{ "meta": { "total_records": 3859, "timestamp": "2026-06-02T18:31:43Z" }, "data": [ { "title": "United for Health: EMA in WorldPride 2026", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "Science and health belong to everyone", "first_published_date": "01/06/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/united-health-ema-worldpride-2026" }, { "title": "ETF recommends updating COVID-19 vaccines to target XFG variant", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "Updated vaccines will help maintain protection against disease as virus continues to evolve", "first_published_date": "29/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-xfg-variant" }, { "title": "EU recommendations for 2026/2027 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "Annual updates to virus strains ensure vaccines stay effective", "first_published_date": "30/03/2026", "last_updated_date": "26/05/2026", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2026-2027-seasonal-flu-vaccine-composition" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026", "press_release": "No", "related_medicine_referral": "Nobivac NXT HC;Nobivac NXT HCP;Nobivac NXT HCPCh;BTVPUR;Respivac aMPV (previously Respivac TRT)", "categories": "Veterinary", "topics": "Medicines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "22/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-19-21-may-2026" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026", "press_release": "No", "related_medicine_referral": "Boey;Etcamah;Jascayd;Vijoice;Ablymico;Liraglutide STADA;Colchicine Agepha Pharma;Vislyfa;Deqtynet;Braftovi;Enhertu;Erbitux;Fasenra;Hetronifly;Iclusig;Keytruda;Maviret;Padcev;Palynziq;Sogroya;Tepkinly;Trodelvy;Veblocema;Orblid;Wegovy", "categories": "Human", "topics": "Medicines", "news_summary": "Eight new medicines recommended for approval; another 13 medicines recommended for extension of their therapeutic indications", "first_published_date": "22/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-may-2026" }, { "title": "New medicine for two types of pulmonary fibrosis", "press_release": "No", "related_medicine_referral": "Jascayd", "categories": "Human", "topics": "Medicines", "news_summary": "Jascayd slowed loss of lung function in patients with idiopathic or progressive pulmonary fibrosis", "first_published_date": "22/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-two-types-pulmonary-fibrosis" }, { "title": "First medicine to treat rare uncontrolled growth of body tissues", "press_release": "No", "related_medicine_referral": "Vijoice", "categories": "Human", "topics": "Medicines", "news_summary": "Vijoice addresses an unmet medical need for patients with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders", "first_published_date": "22/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-medicine-treat-rare-uncontrolled-growth-body-tissues" }, { "title": "First oral GLP-1 treatment for weight management", "press_release": "No", "related_medicine_referral": "Wegovy", "categories": "Human", "topics": "Medicines", "news_summary": "Wegovy tablets offer an alternative to subcutaneous injections", "first_published_date": "22/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-oral-glp-1-treatment-weight-management" }, { "title": "EMA closed on Whit Monday, 25 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on Friday 22 May until 08:30 on Tuesday 26 May", "first_published_date": "21/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-whit-monday-25-may" }, { "title": "EU tracks progress towards 2030 clinical trial targets", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "19 multinational clinical trials have been authorised in addition to the historical average; 40.5% of the total number of clinical trials recruit participants within 200 days", "first_published_date": "20/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-tracks-progress-towards-2030-clinical-trial-targets" }, { "title": "EMA actively monitoring cruise ship Hantavirus outbreak", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "Risk for the general population currently considered very low by ECDC", "first_published_date": "12/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-actively-monitoring-cruise-ship-hantavirus-outbreak" }, { "title": "EMA business hours over Ascension Day holidays, 14 and 15 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on Wednesday 13 May until 08:30 on Monday 18 May", "first_published_date": "12/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-ascension-day-holidays-14-15-may" }, { "title": "EMA welcomes political agreement on Critical Medicines Act", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages;Medicines", "news_summary": "Act to improve availability, production and supply of critical medicines in the European Union", "first_published_date": "12/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-critical-medicines-act" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2026", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use", "first_published_date": "08/05/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-may-2026" }, { "title": "EMA launches new advisory group on vaccine confidence", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "International panel of high-level experts will support EMA’s efforts to strengthen trust in vaccines", "first_published_date": "29/04/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-launches-new-advisory-group-vaccine-confidence" }, { "title": "New pilot to support development of ‘breakthrough’ medical devices", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medical devices", "news_summary": "Enhanced regulatory support and priority access to scientific advice for developers", "first_published_date": "28/04/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-pilot-support-development-breakthrough-medical-devices" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026", "press_release": "No", "related_medicine_referral": "Cenrifki;Itvisma;Redemplo;Palbociclib Viatris;Rexatilux;Agamree;Aquipta;Inaqovi;Opdivo;Privigen;Skyrizi;Venclyxto;Opdualag;Pluvicto;Viokat;Comirnaty", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "Five new medicines recommended for approval; another nine medicines recommended for extension of their therapeutic indications", "first_published_date": "24/04/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-april-2026" }, { "title": "New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome", "press_release": "No", "related_medicine_referral": "Redemplo", "categories": "Human", "topics": "Medicines", "news_summary": "Redemplo provides new treatment option for patients with a high unmet medical need", "first_published_date": "24/04/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-reduce-triglycerides-adults-familial-chylomicronaemia-syndrome" }, { "title": "EMA business hours over King's Day and Labour Day, 27 April and 1 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed for King's Day in the Netherlands on Monday 27 April and for Labour Day on Friday 1 May", "first_published_date": "23/04/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-kings-day-labour-day-27-april-1-may" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 April 2026", "press_release": "No", "related_medicine_referral": "Nobivac NXT HCPChFeLV;Solensia;Startvac;Vectormune HVT-AIV", "categories": "Veterinary", "topics": "Medicines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "17/04/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-14-16-april-2026" }, { "title": "EMA recommends authorisation of first veterinary vaccine using RNA technology", "press_release": "No", "related_medicine_referral": "Nobivac NXT HCPChFeLV", "categories": "Veterinary", "topics": "Vaccines", "news_summary": "Nobivac NXT HCPChFeLV helps protect against common, highly contagious infections in cats", "first_published_date": "17/04/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-authorisation-first-veterinary-vaccine-using-rna-technology" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC agrees on communication to healthcare professionals about cases of severe liver injury with epilepsy medicine", "first_published_date": "10/04/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-april-2026" }, { "title": "EMA consults on virtual control groups to help reduce animal use in medicines development", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Innovation;Research and development", "news_summary": "A draft qualification opinion for the new testing method is open for consultation", "first_published_date": "31/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-consults-virtual-control-groups-help-reduce-animal-use-medicines-development" }, { "title": "EMA business hours over Easter holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on 1 April to 08:30 on 7 April", "first_published_date": "31/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-easter-holiday-period-1" }, { "title": "New treatment for relapsed extensive-stage small cell lung cancer", "press_release": "No", "related_medicine_referral": "Imdylltra", "categories": "Human", "topics": "", "news_summary": "Imdylltra addresses unmet need in people with poor prognosis and limited treatment options", "first_published_date": "27/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-relapsed-extensive-stage-small-cell-lung-cancer" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026", "press_release": "No", "related_medicine_referral": "Adstiladrin;Imdylltra;Joenja;Zepzelca;Bopediat;Besponsa;Capvaxive;Feraccru;Hetronifly;Hympavzi;Imcivree;Lojuxta;Mekinist;mResvia;Namuscla;Retsevmo;Sotyktu;Tafinlar;Blarcamesine Anavex;Hetlioz;Tecovirimat SIGA", "categories": "Human", "topics": "Medicines", "news_summary": "Five new medicines recommended for approval; another 13 medicines recommended for extension of their therapeutic indications", "first_published_date": "27/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-2026" }, { "title": "EMA recommends restricting use of Tecovirimat SIGA", "press_release": "No", "related_medicine_referral": "Tecovirimat SIGA;Tecovirimat SIGA", "categories": "Human", "topics": "Referrals", "news_summary": "The medicine was not effective for the treatment of mpox in randomised clinical trials", "first_published_date": "27/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-restricting-use-tecovirimat-siga" }, { "title": "New PRIME tools to accelerate development of medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "PRIME", "news_summary": "Three new PRIME features streamline scientific dialogue and help developers to stay on track", "first_published_date": "18/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-prime-tools-accelerate-development-medicines-eu" }, { "title": "EMA Management Board: highlights of March 2026 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Clinical trials;Medicine shortages", "news_summary": "Board adopts Agency’s 2025 annual report and notes electronic product information implementation roadmap", "first_published_date": "13/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2026-meeting" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 March 2026", "press_release": "No", "related_medicine_referral": "AviGate S. Infantis;VeroBlue-3;Syvazul BTV 3;Mometamax Ultra", "categories": "Veterinary", "topics": "Medicines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "13/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-10-12-march-2026" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 March 2026", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC warns about known risk of aseptic meningitis with chikungunya vaccine Ixchiq", "first_published_date": "13/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-march-2026" }, { "title": "New guidance on the conduct of clinical trials during public health emergencies in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "Recommendations to streamline authorisation of new clinical trials and changes to ongoing trials to generate clinical evidence", "first_published_date": "05/03/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-guidance-conduct-clinical-trials-during-public-health-emergencies-eu" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026", "press_release": "No", "related_medicine_referral": "mCombriax;Ojemda;Onerji;Palsonify;Rhapsido;Xolremdi;Bysumlog;Dazparda;Fubelv;Poherdy;Tuyory;Zandoriah;Acoziborole Winthrop;Daybu;Iloperidone Vanda Pharmaceuticals;Dupixent;Jorveza;Keytruda;Olumiant;Scemblix;Stelara;Zumrad", "categories": "Human", "topics": "COVID-19;Medicines;Medicines for use outside the EU;Vaccines", "news_summary": "12 new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications", "first_published_date": "27/02/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-february-2026" }, { "title": "New single-dose oral treatment for human African trypanosomiasis (sleeping sickness)", "press_release": "No", "related_medicine_referral": "Acoziborole Winthrop", "categories": "Human", "topics": "Medicines for use outside the EU", "news_summary": "Acoziborole Winthrop simplifies treatment of first- and second-stage disease caused by T. brucei gambiense", "first_published_date": "27/02/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-single-dose-oral-treatment-human-african-trypanosomiasis-sleeping-sickness" }, { "title": "First combined COVID-19 and influenza vaccine for people 50 years and older", "press_release": "No", "related_medicine_referral": "mCombriax", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "mCombriax helps to protect against both COVID-19 caused by SARS-CoV-2 and seasonal influenza", "first_published_date": "27/02/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-combined-covid-19-influenza-vaccine-people-50-years-older" }, { "title": "New medicine to treat paediatric low-grade glioma", "press_release": "No", "related_medicine_referral": "Ojemda", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "Ojemda addresses unmet need for patients aged 6 months and older with paediatric brain tumour with BRAF alterations", "first_published_date": "27/02/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-treat-paediatric-low-grade-glioma" }, { "title": "Recruitment procedure opens for next Executive Director of the European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "Candidates have until 19 March to apply for the role", "first_published_date": "20/02/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/recruitment-procedure-opens-next-executive-director-european-medicines-agency" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 February 2026", "press_release": "No", "related_medicine_referral": "Emepax;Suvaxyn PRRS MLV;Bluevac BTV (previously Bluevac BTV8);Bravecto;Coxevac;Yurvac RHD;Versican Plus DHPPi/L4;Versican Plus DHPPi/L4R", "categories": "Veterinary", "topics": "Medicines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "13/02/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-10-12-february-2026" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 February 2026", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC concludes safety review of levamisole, a medicine used to treat parasitic worm infections", "first_published_date": "13/02/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-february-2026" }, { "title": "EMA recommends withdrawal of marketing authorisations for levamisole medicines", "press_release": "No", "related_medicine_referral": "Levamisole-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "Leukoencephalopathy confirmed as a serious side effect of levamisole", "first_published_date": "13/02/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-withdrawal-marketing-authorisations-levamisole-medicines" }, { "title": "First treatment for rare thymidine kinase 2 deficiency", "press_release": "No", "related_medicine_referral": "Kygevvi", "categories": "Human", "topics": "PRIME;Medicines;Rare diseases", "news_summary": "Kygevvi improves motor function of patients with disease onset at or before 12 years of age", "first_published_date": "30/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-rare-thymidine-kinase-2-deficiency" }, { "title": "New medicine to treat chronic graft-versus-host disease", "press_release": "No", "related_medicine_referral": "Rezurock", "categories": "Human", "topics": "Medicines;Rare diseases", "news_summary": "Rezurock addresses unmet need when other treatments are unsuccessful or unsuitable", "first_published_date": "30/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-treat-chronic-graft-versus-host-disease" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 26-29 January 2026", "press_release": "No", "related_medicine_referral": "Fylrevy;Ilumira;Kayshild;Kygevvi;Supemtek;Akeega;Efmody;Eurneffy;Imfinzi;Kerendia;Noxafil;Opdivo;Zynyz;Iclusig;Rezurock;Tavneos;Mounjaro", "categories": "Human", "topics": "Medicines", "news_summary": "Six new medicines recommended for approval; another nine medicines recommended for extension of their therapeutic indications", "first_published_date": "30/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-26-29-january-2026" }, { "title": "EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA", "press_release": "No", "related_medicine_referral": "Tavneos;Tavneos", "categories": "Human", "topics": "Referrals", "news_summary": "Review prompted by questions regarding data integrity of main study", "first_published_date": "30/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-tavneos-medicine-rare-autoimmune-diseases-gpa-mpa" }, { "title": "First immunotherapy-based treatment recommended for advanced anal cancer", "press_release": "No", "related_medicine_referral": "Zynyz", "categories": "Human", "topics": "Medicines", "news_summary": "Zynyz provides an option for adults with squamous cell carcinoma of the anal canal", "first_published_date": "30/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-immunotherapy-based-treatment-recommended-advanced-anal-cancer" }, { "title": "Ilona Reischl re-elected as chair of Committee for Advanced Therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Advanced therapies", "news_summary": "Ilona Reischl’s second three-year mandate will begin in February 2026", "first_published_date": "23/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ilona-reischl-re-elected-chair-committee-advanced-therapies" }, { "title": "Carmen Purdel elected as new chair of the Committee for Herbal Medicinal Products", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Herbal;Corporate", "topics": "", "news_summary": "Carmen Purdel will begin her three-year mandate in March 2026.", "first_published_date": "21/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/carmen-purdel-elected-new-chair-committee-herbal-medicinal-products" }, { "title": "Use of paracetamol during pregnancy unchanged in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "Paracetamol medicines can be used in pregnancy, in accordance with official recommendations", "first_published_date": "23/09/2025", "last_updated_date": "20/01/2026", "news_url": "https://www.ema.europa.eu/en/news/use-paracetamol-during-pregnancy-unchanged-eu" }, { "title": "Veterinary medicines in 2025", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "30 new medicines recommended for approval; 13 with a new active substance", "first_published_date": "19/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-2025" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 January 2026", "press_release": "No", "related_medicine_referral": "Lotilaner / Milbemycin Elanco;Arti-Cell Forte;Librela;Equip WNV (previously Duvaxyn WNV);Suvaxyn CSF Marker;Suvaxyn Circo+MH RTU;Cytopoint;Suvaxyn Circo;Suvaxyn PRRS MLV;CircoMax;CircoMax Myco;Solensia;Purevax RCPCh;Purevax RCPCh FeLV;Strangvac;Vectormune ND;Vectormune HVT-AIV;Newflend ND H9;Ultifend ND IBD;Versican Plus DHPPi/L4;Versican Plus DHPPi/L4R;Versican Plus DHPPi;Versican Plus Pi;Versican Plus Pi/L4;Versican Plus Pi/L4R;Bluevac-3", "categories": "Veterinary", "topics": "Medicines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "16/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-13-14-january-2026" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12 - 15 January 2026", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use", "first_published_date": "16/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-12-15-january-2026" }, { "title": "Human medicines in 2025", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "104 new medicines recommended for approval; 38 had a new active substance", "first_published_date": "15/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-2025" }, { "title": "EMA and FDA set common principles for AI in medicine development", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Data on medicines", "news_summary": "Advancing safe, ethical and aligned AI practices across the medicines lifecycle", "first_published_date": "14/01/2026", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0" }, { "title": "Emer Cooke, EMA’s Executive Director: 2025 achievements in medicine regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "EMA's Executive Director shares her end-of-year message and takes stock of EMA's work in 2025.", "first_published_date": "19/12/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emer-cooke-emas-executive-director-2025-achievements-medicine-regulation" }, { "title": "EMA Management Board: highlights of December 2025 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate;Clinical trials;Data on medicines;Medicines", "news_summary": "Board welcomes political agreement on new pharmaceutical legislation and adopts work programme for 2026", "first_published_date": "19/12/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2025-meeting" }, { "title": "EMA business hours over holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on 22 December to 08:30 on 5 January", "first_published_date": "19/12/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-holiday-period-2" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025", "press_release": "No", "related_medicine_referral": "Anktiva;Aumseqa;Exdensur;Myqorzo;mNexspike;Gotenfia;Ranluspec;Aspaveli;Arexvy;Dovprela (previously Pretomanid FGK);Elucirem;Eylea;Mounjaro;Nucala;Recarbrio;Simponi;Uplizna;Vueway;Winrevair;Jelrix;Hetlioz;Melatomed and associated names;Vfend", "categories": "Human", "topics": "Medicines", "news_summary": "Seven new medicines recommended for approval; another 12 medicines recommended for extension of their therapeutic indications", "first_published_date": "12/12/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-8-11-december-2025" }, { "title": "New medicine to treat non-muscle invasive bladder cancer", "press_release": "No", "related_medicine_referral": "Anktiva", "categories": "Human", "topics": "Medicines", "news_summary": "Anktiva provides an alternative to surgery for patients whose cancer does not respond to treatment with Bacillus Calmette-Guérin", "first_published_date": "12/12/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-treat-non-muscle-invasive-bladder-cancer" }, { "title": "EMA welcomes political agreement on new EU pharmaceutical legislation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "Reform to enhance patient access, strengthen medicine supply security and boost innovation", "first_published_date": "11/12/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation" }, { "title": "New data on antimicrobials sales and use in animals in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "Report showing small increase in sales, new dashboard launched", "first_published_date": "09/12/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-data-antimicrobials-sales-use-animals-eu" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 2-4 December 2025", "press_release": "No", "related_medicine_referral": "Orbyk EHD (previously Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A.);Firocoxib CP-Pharma;Varenzin;Dexdomitor;Felpreva;Mirataz;AdTab (previously Lotilaner Elanco);Duotic;Osurnia;Eluracat;Meloxidyl;NexGard;Nexgard Spectra;Frontpro (previously Afoxolaner Merial);ProteqFlu-Te;Sileo;Zuprevo", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "05/12/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-2-4-december-2025" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 November 2025", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use", "first_published_date": "28/11/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-november-2025" }, { "title": "Call for expressions of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "Three members and alternates representing healthcare professionals and three members and alternates representing patients’ associations will be appointed", "first_published_date": "20/11/2025", "last_updated_date": "27/11/2025", "news_url": "https://www.ema.europa.eu/en/news/call-expressions-interest-civil-society-representatives-participate-work-emas-paediatric-committee" }, { "title": "First-in-class treatment to delay onset of type 1 diabetes", "press_release": "No", "related_medicine_referral": "Teizeild", "categories": "Human", "topics": "Medicines", "news_summary": "Teizeild significantly delays onset of stage 3 diabetes and preserves functioning of cells producing insulin", "first_published_date": "14/11/2025", "last_updated_date": "20/11/2025", "news_url": "https://www.ema.europa.eu/en/news/first-class-treatment-delay-onset-type-1-diabetes" }, { "title": "Improved scientific advice for medicines for public health threats including antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials;Medicines;Scientific advice", "news_summary": "New approach brings together clinical trial and ethics expertise to accelerate development of medicines for use ahead of or during emergencies", "first_published_date": "17/11/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/improved-scientific-advice-medicines-public-health-threats-including-antimicrobial-resistance" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 November 2025", "press_release": "No", "related_medicine_referral": "Dawnzera;GalenVita;Inluriyo;Teizeild;VacPertagen;Waskyra;Ondibta;Osqay;Enzalutamide Accordpharma;Teduglutide Viatris;Koselugo;Minjuvi;Veyvondi;Xerava;Aqneursa;Insulin Aspart Injection;Nurzigma;Ohtuvayre;Hetlioz;Rezurock", "categories": "Human", "topics": "Medicines", "news_summary": "Ten new medicines recommended for approval; another four medicines recommended for extension of their therapeutic indications", "first_published_date": "14/11/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-november-2025" }, { "title": "First gene therapy to treat rare disease Wiskott-Aldrich syndrome", "press_release": "No", "related_medicine_referral": "Waskyra", "categories": "Human", "topics": "Medicines", "news_summary": "Waskyra significantly reduces infections and bleeding episodes in people with life-threatening immunodeficiency", "first_published_date": "14/11/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-gene-therapy-treat-rare-disease-wiskott-aldrich-syndrome" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 November 2025", "press_release": "No", "related_medicine_referral": "Vaxxinact H5;Ecovaxxin MS;Credelio;Lotimax;Credelio Plus;Frontpro (previously Afoxolaner Merial);Mhyosphere PCV ID;Librela", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "07/11/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-4-6-november-2025" }, { "title": "EMA partners with healthcare professionals and consumers for #ItTakesATeam medicine shortages campaign", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "Campaign highlights how different actors can help in case of a shortage", "first_published_date": "04/11/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-partners-healthcare-professionals-consumers-ittakesateam-medicine-shortages-campaign" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 - 30 October 2025", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC agrees on a communication to healthcare professionals on injectable tranexamic acid medicines", "first_published_date": "31/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-october-2025" }, { "title": "ICMRA Summit 2025: EMA concludes its two mandates as chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "ICMRA elects new chair in Amsterdam", "first_published_date": "24/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/icmra-summit-2025-ema-concludes-its-two-mandates-chair" }, { "title": "EMA partners with content creators to promote safe and responsible use of GLP-1 medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "#HealthNotHype social media campaign aims to expand audience reach of public health messages", "first_published_date": "21/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-partners-content-creators-promote-safe-responsible-use-glp-1-medicines" }, { "title": "First treatment for serious chronic lung disease", "press_release": "No", "related_medicine_referral": "Brinsupri", "categories": "Human", "topics": "Medicines", "news_summary": "Brinsupri significantly reduces and delays the occurrence of pulmonary exacerbations in patients with non-cystic fibrosis bronchiectasis", "first_published_date": "17/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-serious-chronic-lung-disease" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025", "press_release": "No", "related_medicine_referral": "Brinsupri;Wayrilz;Rezurock;Austedo;Breyanzi;Cejemly;Gazyvaro;Libtayo;Paxlovid;Pyrukynd;Tremfya;Scemblix;Hydrocortisone Aguettant;Oxbryta", "categories": "Human", "topics": "Medicines", "news_summary": "Two new medicines recommended for approval; another eight medicines recommended for extension of their therapeutic indications", "first_published_date": "17/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-october-2025" }, { "title": "EMA confirms suspension of sickle cell disease medicine Oxbryta", "press_release": "No", "related_medicine_referral": "Oxbryta", "categories": "Human", "topics": "Referrals", "news_summary": "Higher rate of death and disease complications in recent trials means benefit-risk balance no longer favourable", "first_published_date": "17/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-suspension-sickle-cell-disease-medicine-oxbryta" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 October 2025", "press_release": "No", "related_medicine_referral": "Lenivia;Vaxxitek HVT+IBD+H5;Yurvac RHD;Vectormune HVT-AIV;Respiporc FLUpan H1N1;Respiporc Flu3;Posatex;Mometamax Ultra;Emdocam;Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "10/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-7-9-october-2025" }, { "title": "EMA Management Board: highlights of October 2025 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Data on medicines;Medicines", "news_summary": "Board notes mid-year report and endorses first network data strategy", "first_published_date": "03/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2025-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September - 2 October 2025", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use", "first_published_date": "03/10/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-september-2-october-2025" }, { "title": "Advice on end-of-year submission dates for type I variations in 2025", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "Regulatory update", "first_published_date": "02/10/2025", "last_updated_date": "02/10/2025", "news_url": "https://www.ema.europa.eu/en/news/advice-end-year-submission-dates-type-i-variations-2025" }, { "title": "A path to better include patients’ perspectives in the regulation of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "Reflection paper on patient experience data for public consultation until 31 January 2026", "first_published_date": "29/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/path-better-include-patients-perspectives-regulation-medicines" }, { "title": "New co-chairs elected for working parties for healthcare professionals and for patients and consumers", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Paediatrics", "news_summary": "The Patients and Consumer Working Party (PCWP), and the Healthcare Profesionals' Working Party (HCPWP), held elections for new co-chairs on September 23", "first_published_date": "24/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-co-chairs-elected-working-parties-healthcare-professionals-patients-consumers" }, { "title": "New targets for clinical trials in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "500 authorised multinational clinical trials to be added over five years", "first_published_date": "23/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-targets-clinical-trials-europe" }, { "title": "New variations guidelines to streamline lifecycle management of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance", "news_summary": "Measures to facilitate quicker processing of variations", "first_published_date": "22/09/2025", "last_updated_date": "22/09/2025", "news_url": "https://www.ema.europa.eu/en/news/new-variations-guidelines-streamline-lifecycle-management-medicines" }, { "title": "First treatment recommended for rare immunoglobulin-related autoimmune disease", "press_release": "No", "related_medicine_referral": "Uplizna", "categories": "Human", "topics": "Medicines", "news_summary": "Uplizna significantly reduced the number of flares in patients with active immunoglobulin G4-related disease", "first_published_date": "19/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-recommended-rare-immunoglobulin-related-autoimmune-disease" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025", "press_release": "No", "related_medicine_referral": "Acvybra;Amtagvi;Atropine sulfate FGK;Bimervax;Degevma;Vysribli (previously Denosumab Intas);Dupixent;Enflonsia;Fanskya;Gobivaz;Imaavy;Kefdensis;Keytruda;Koselugo;Kyinsu;Lunsumio;Lutathera;Lynkuet;Omforro;Norvir;Ponlimsi;Rivaroxaban Koanaa;Tezspire;Tuzodi;Uplizna;Usgena;Winlevi;Xbonzy;Zvogra;Remsima", "categories": "Human", "topics": "Medicines", "news_summary": "14 new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications", "first_published_date": "19/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-september-2025" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 9-10 September 2025", "press_release": "No", "related_medicine_referral": "Bravecto TriUNO;Portela;Divence Tetra;ArthriCox;BTVPUR;Credelio;Credelio Plus;Lotimax;AdTab (previously Lotilaner Elanco);Cytopoint;Draxxin;Easotic;Emevet;Equilis Te;Equilis Prequenza Te;Equioxx;Felpreva;ProZinc;RenuTend;Semintra;Senvelgo;Simparica Trio;Strangvac;Tulinovet;Chanhold;Evicto;Meloxidolor;Novaquin;Osurnia;Strangvac;Zulvac 1+8 Bovis;Zulvac 1+8 Ovis;Zulvac SBV", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "12/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-9-10-september-2025" }, { "title": "Management Board formally approves renewal of Executive Director’s mandate", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "Board’s decision concludes renewal process", "first_published_date": "10/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/management-board-formally-approves-renewal-executive-directors-mandate" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1 – 4 September 2025", "press_release": "No", "related_medicine_referral": "Levamisole-containing medicinal products;Crysvita;Remsima", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "PRAC starts safety review of levamisole, a medicine used to treat parasitic worm infections", "first_published_date": "05/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-4-september-2025" }, { "title": "PRAC starts safety review of levamisole, a medicine used to treat parasitic worm infections", "press_release": "No", "related_medicine_referral": "Levamisole-containing medicinal products", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "Review will assess risk of leukoencephalopathy, a condition affecting the brain", "first_published_date": "05/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prac-starts-safety-review-levamisole-medicine-used-treat-parasitic-worm-infections" }, { "title": "Warning about sharp rise in illegal medicines sold in the EU", "press_release": "No", "related_medicine_referral": "Ozempic;Saxenda;Trulicity;Victoza", "categories": "Human", "topics": "Medicines", "news_summary": "Illegal medicines marketed as GLP-1 receptor agonists for weight loss and diabetes pose serious risk to health", "first_published_date": "03/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/warning-about-sharp-rise-illegal-medicines-sold-eu" }, { "title": "EMA and WHO mark ten years of collaboration to advance global access to medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Corporate;Medicines for use outside the EU", "news_summary": "Key partnership leverages EMA’s scientific expertise and WHO’s mandate to improve access to safe and effective medicines worldwide", "first_published_date": "01/09/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-who-mark-ten-years-collaboration-advance-global-access-medicines" }, { "title": "EMA closed on 15 August for Assumption Day", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on 14 August 2025 to 08:30 on 18 August 2025", "first_published_date": "13/08/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-15-august-assumption-day" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025", "press_release": "No", "related_medicine_referral": "Aplidin;Aqneursa;Baqsimi;Bildyos;Bilprevda;Clopidogrel Zentiva (previously Clopidogrel Winthrop);Comirnaty;Ekterly;Elevidys;Eyluxvi;Ifinwil;Invokana;Ixchiq;Jelrix;Kisunla;Macitentan Accord;Macitentan AccordPharma;mResvia;Neuraceq;Nurzigma;Romvimza;Sirturo;Spikevax (previously COVID-19 Vaccine Moderna);Taltz;Tecovirimat SIGA;Tevimbra;Tryngolza;Usrenty;Voranigo;Yeytuo;Zurzuvae;Lenacapavir Gilead", "categories": "Human", "topics": "Medicines", "news_summary": "13 new medicines recommended for approval; another 8 medicines recommended for extension of their therapeutic indications", "first_published_date": "25/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-july-2025" }, { "title": "First reformulation of an inhaled medicine with environmentally friendly gas propellant", "press_release": "No", "related_medicine_referral": "Trixeo Aerosphere;Riltrava Aerosphere", "categories": "Human", "topics": "Medicines", "news_summary": "The new propellant in Trixeo Aerosphere and Riltrava Aerosphere has lower global warming potential", "first_published_date": "25/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-reformulation-inhaled-medicine-environmentally-friendly-gas-propellant" }, { "title": "New injection for easier prevention of HIV infection in the EU and worldwide", "press_release": "No", "related_medicine_referral": "Yeytuo;Lenacapavir Gilead", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "Injectable lenacapavir, administered twice yearly, is highly effective at preventing HIV", "first_published_date": "25/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-injection-easier-prevention-hiv-infection-eu-worldwide" }, { "title": "New treatment for Niemann-Pick type C disease", "press_release": "No", "related_medicine_referral": "Aqneursa", "categories": "Human", "topics": "Medicines", "news_summary": "Aqneursa significantly improves neurological signs, symptoms and functioning", "first_published_date": "25/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-niemann-pick-type-c-disease" }, { "title": "Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted", "press_release": "No", "related_medicine_referral": "Ixchiq", "categories": "Human", "topics": "Referrals", "news_summary": "Vaccine to be used only when there is a significant chikungunya risk and after careful consideration of the benefits and risks", "first_published_date": "25/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ixchiq-temporary-restriction-vaccinating-people-65-years-older-be-lifted-0" }, { "title": "EMA Paediatric Committee elects Sabine Scherer as its new chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Paediatrics", "news_summary": "Sabine Scherer begins her three-year mandate in September 2025", "first_published_date": "24/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-paediatric-committee-elects-sabine-scherer-its-new-chair" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-17 July 2025", "press_release": "No", "related_medicine_referral": "Cevac Reomune;Hemosyvet;Syvazul BTV 3;Nobivac L4;Nobivac LoVo L4;Quarter-based selective dry cow therapy;Eluracat;Divence IBR Marker Live;Neptra;Bovela;Clynav;Evanovo;Gumbohatch;Suprelorin;Tulaven;Prevexxion RN+HVT+IBD;Recocam;Zulvac 8 Ovis;Galliprant", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "18/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-15-17-july-2025" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 – 10 July 2025", "press_release": "No", "related_medicine_referral": "Ixchiq;Ixchiq;Varilrix;Valproate", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted", "first_published_date": "11/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-july-2025" }, { "title": "Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted", "press_release": "No", "related_medicine_referral": "Ixchiq;Ixchiq", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "Vaccine to be used only when there is a significant chikungunya risk and after careful consideration of the benefits and risks", "first_published_date": "11/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ixchiq-temporary-restriction-vaccinating-people-65-years-older-be-lifted" }, { "title": "Strengthening supply chain of anti-D immunoglobulins", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "EMA and HMA recommendations to address vulnerabilities in the supply of critical medicines used during pregnancy", "first_published_date": "04/07/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/strengthening-supply-chain-anti-d-immunoglobulins" }, { "title": "EMA starts review of sodium oxybate in alcohol dependence", "press_release": "No", "related_medicine_referral": "Sodium oxybate-containing syrup and oral solution for alcohol dependence", "categories": "Human", "topics": "Referrals", "news_summary": "Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse", "first_published_date": "20/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-sodium-oxybate-alcohol-dependence" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 June 2025", "press_release": "No", "related_medicine_referral": "Austedo;Ogsiveo;Benlysta;Cabometyx;Dapivirine Vaginal Ring 25 mg;Darzalex;Eiyzey;Helicobacter Test INFAI;Imbruvica;Imreplys;Kisunla;Mynzepli;Nintedanib Viatris;Nubeqa;Rezdiffra;Sarclisa;Uplizna;Usymro;Vgenfli;Vivlipeg;Zemcelpro;Afiveg;Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris;Sodium oxybate-containing syrup and oral solution for alcohol dependence", "categories": "Human", "topics": "Medicines;Medicines for use outside the EU;Referrals", "news_summary": "13 new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications", "first_published_date": "20/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-june-2025" }, { "title": "New stem cell therapy to treat patients with blood cancers", "press_release": "No", "related_medicine_referral": "Zemcelpro", "categories": "Human", "topics": "Medicines", "news_summary": "Zemcelpro provides an option for patients with blood cancer who need a blood stem cell transplant and have no suitable donor", "first_published_date": "20/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-stem-cell-therapy-treat-patients-blood-cancers" }, { "title": "First treatment against liver scarring caused by a type of ‘fatty liver disease’", "press_release": "No", "related_medicine_referral": "Rezdiffra", "categories": "Human", "topics": "Medicines", "news_summary": "Rezdiffra is indicated for patients with moderate to advanced scarring due to accumulation of fat", "first_published_date": "20/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-against-liver-scarring-caused-type-fatty-liver-disease" }, { "title": "EMA Management Board: highlights of June 2025 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "Board meets African Medicines Agency Governing Board and adopts Executive Director’s annual activity report for 2024", "first_published_date": "13/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2025-meeting" }, { "title": "First vaccine against swine dysentery disease recommended for approval", "press_release": "No", "related_medicine_referral": "Biobhyo", "categories": "Veterinary", "topics": "Vaccines", "news_summary": "Vaccine to protect animal health and prevent economic losses", "first_published_date": "13/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-vaccine-against-swine-dysentery-disease-recommended-approval" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 June 2025", "press_release": "No", "related_medicine_referral": "Biobhyo;Bravecto CombiUNO;Daxocox;Nobivac L4;Nobivac LoVo L4;Numelvi;Poulvac E. coli;Zenrelia;NexGard;Nexgard Spectra;Bravecto;Ecoporc Shiga;Nobilis IB Primo QX;Nobilis IB 4-91;Imoxat;Meloxidyl;Mometamax Ultra;Reconcile;Innovax-ND-H5", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "13/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-10-12-june-2025" }, { "title": "PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy", "press_release": "No", "related_medicine_referral": "Ozempic;Rybelsus;Wegovy", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "Treatment with semaglutide should be stopped if NAION occurs", "first_published_date": "06/06/2025", "last_updated_date": "13/06/2025", "news_url": "https://www.ema.europa.eu/en/news/prac-concludes-eye-condition-naion-very-rare-side-effect-semaglutide-medicines-ozempic-rybelsus-wegovy" }, { "title": "2024 annual report is published", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "", "news_summary": "Report highlights progress in science, medicines and health in 2024", "first_published_date": "10/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/2024-annual-report-published" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 June 2025", "press_release": "No", "related_medicine_referral": "Ozempic;Rybelsus;Wegovy", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "EMA concludes review of semaglutide medicines and starts review of two chickenpox vaccines", "first_published_date": "06/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-june-2025" }, { "title": "EMA closed 9 June", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency (EMA) is closed from 18:00 on Friday 6 June until 08:30 on Tuesday 10 June", "first_published_date": "05/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-9-june" }, { "title": "New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "Recommendations will support better information on benefits and risks of medicines in this population", "first_published_date": "04/06/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-guideline-inclusion-pregnant-breastfeeding-individuals-clinical-trials" }, { "title": "EMA closed 29-30 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency (EMA) is closed from 18:00 on Wednesday 28 May 2025 until 08:30 on Monday 2 June 2025", "first_published_date": "28/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-29-30-may" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025", "press_release": "No", "related_medicine_referral": "Atropine sulfate FGK;Aucatzyl;Azithromycin-containing medicinal products for systemic use;Blenrep;Bomyntra;Conexxence;Ezmekly;Imfinzi;Itovebi;Lutathera;Maapliv;Rezolsta;Riulvy;Rolcya;Saxenda;Teriparatide Ascend;Winlevi;Kinselby;Tevimbra", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "Ten new medicines recommended for approval; another four medicines recommended for extension of their therapeutic indications", "first_published_date": "23/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-may-2025" }, { "title": "Changes to the use of antibiotic azithromycin", "press_release": "No", "related_medicine_referral": "Azithromycin-containing medicinal products for systemic use", "categories": "Human", "topics": "Referrals", "news_summary": "Recommendations aim to optimise use and minimise development of antimicrobial resistance", "first_published_date": "23/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/changes-use-antibiotic-azithromycin" }, { "title": "EMA starts review of ipidacrine-containing medicines", "press_release": "No", "related_medicine_referral": "Ipidacrine-containing medicinal products", "categories": "Human", "topics": "Referrals", "news_summary": "Review will evaluate effectiveness in authorised uses and liver safety", "first_published_date": "23/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-ipidacrine-containing-medicines" }, { "title": "New treatment for adults with acute lymphoblastic leukaemia", "press_release": "No", "related_medicine_referral": "Aucatzyl", "categories": "Human", "topics": "Rare diseases", "news_summary": "Third CAR T-cell therapy for high-mortality cancer", "first_published_date": "23/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-adults-acute-lymphoblastic-leukaemia" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 May 2025", "press_release": "No", "related_medicine_referral": "Innovax-ND-IBD-ILT;Fluralaner Intervet;Nobilis Multriva IBm+ND+Gm+REOm+EDS;NexGard Combo;Stronghold Plus;Bluevac BTV (previously Bluevac BTV8);Divence Penta;Mirataz;Pexion;Profender;Procox;Felpreva;Coxatab;DogStem;HorStem;Melovem;Oncept IL-2;Profender", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "16/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-13-15-may-2025" }, { "title": "ETF recommends updating COVID-19 vaccines to target new LP.8.1 variant", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "Updated vaccines will help maintain protection against disease as virus continues to evolve", "first_published_date": "16/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-lp81-variant" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2025", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products;Ixchiq;Ixchiq", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "Review of medicines containing finasteride and dutasteride concluded", "first_published_date": "08/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-may-2025" }, { "title": "Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "Suicidal thoughts confirmed as side effect of finasteride tablets; no direct link found for dutasteride", "first_published_date": "08/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/measures-minimise-risk-suicidal-thoughts-finasteride-dutasteride-medicines" }, { "title": "Leveraging the power of data for public and animal health", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Data on medicines;Innovation;Research and development", "news_summary": "EU regulators agree workplan to optimise use of data and artificial intelligence (AI)", "first_published_date": "07/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/leveraging-power-data-public-animal-health" }, { "title": "EMA starts review of Ixchiq (live attenuated chikungunya vaccine)", "press_release": "No", "related_medicine_referral": "Ixchiq;Ixchiq", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "Vaccine must not be used in people 65 years and above while review is underway", "first_published_date": "07/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-ixchiq-live-attenuated-chikungunya-vaccine" }, { "title": "EMA closed on 9 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on 8 May 2025 to 08:30 on 12 May 2025", "first_published_date": "07/05/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-9-may" }, { "title": "EMA closed 1 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on 30 April 2025 to 08:30 on 2 May 2025", "first_published_date": "29/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-1-may-0" }, { "title": "Management Board meeting on possible renewal of Executive Director’s mandate", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "Consultation of the Board constitutes first step of renewal process", "first_published_date": "28/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/management-board-meeting-possible-renewal-executive-directors-mandate" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2025", "press_release": "No", "related_medicine_referral": "Alyftrek;Attrogy;Duvyzat;Oczyesa;Sephience;Tepezza;Ziihera;Denbrayce;Evfraxy;Enwylma;Izamby;Junod;Vevzuo;Yaxwer;Zadenvi;Adcetris;Adempas;Amvuttra;Calquence;Cystadrops;Jivi;Veklury;Vyvgart;Zoonotic Influenza Vaccine Seqirus;Kisunla;Dazluma;Ngenla;Xofluza;Winlevi", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "16 new medicines recommended for approval; another ten medicines recommended for extension of their therapeutic indications", "first_published_date": "25/04/2025", "last_updated_date": "25/04/2025", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2025" }, { "title": "New treatment against Duchenne muscular dystrophy", "press_release": "No", "related_medicine_referral": "Duvyzat", "categories": "Human", "topics": "Medicines", "news_summary": "Duvyzat can be used in a wide patient population from the age of six", "first_published_date": "25/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-against-duchenne-muscular-dystrophy" }, { "title": "First treatment against severe thyroid eye disease", "press_release": "No", "related_medicine_referral": "Tepezza", "categories": "Human", "topics": "Medicines", "news_summary": "Tepezza significantly improves symptoms for patients with moderate-to-severe TED", "first_published_date": "25/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-against-severe-thyroid-eye-disease" }, { "title": "EMA business hours over Easter holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on 16 April 2025 to 08:30 on 22 April 2025", "first_published_date": "15/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-easter-holiday-period-0" }, { "title": "Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "EMA and HMA encourage strengthening Europe’s production capacity", "first_published_date": "14/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/tackling-vulnerabilities-supply-chain-radiopharmaceuticals-eu" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-9 April 2025", "press_release": "No", "related_medicine_referral": "Emevet;Nobilis Multriva Gm+REOm;Nobilis Multriva IBm+ND;Clevor;ReproCyc ParvoFLEX;Newflend ND H9;Vectormune ND;Zycortal", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "11/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-8-9-april-2025" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2025", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use", "first_published_date": "11/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-april-2025" }, { "title": "EU recommendations for 2025/2026 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "Yearly updates to virus strains ensure vaccine effectiveness", "first_published_date": "01/04/2025", "last_updated_date": "09/04/2025", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2025-2026-seasonal-flu-vaccine-composition" }, { "title": "Clinical Trials Information System designated as WHO primary registry", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "Designation facilitates data sharing, promotes transparency and trust in clinical research", "first_published_date": "03/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/clinical-trials-information-system-designated-who-primary-registry" }, { "title": "Streamlining development and assessment of biosimilar medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Biosimilars", "news_summary": "Proposal aims to encourage development and improve patient access", "first_published_date": "01/04/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/streamlining-development-assessment-biosimilar-medicines" }, { "title": "First report on EU-wide sales and use of antimicrobials in animals", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "Data comes from EU27 plus Iceland and Norway", "first_published_date": "31/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-report-eu-wide-sales-use-antimicrobials-animals" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025", "press_release": "No", "related_medicine_referral": "Amyvid;Bosulif;Calquence;Cinainu;Flucelvax;Insulin Human Rechon;Jubereq;Kisunla;Mysimba;Opdivo;Osvyrti;Pemazyre;Qoyvolma;Ryjunea;Tevimbra;Tremfya;Xoanacyl;Xydalba", "categories": "Human", "topics": "Medicines;Referrals;Vaccines", "news_summary": "Five new medicines recommended for approval; another seven medicines recommended for extension of their therapeutic indications", "first_published_date": "28/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-march-2025" }, { "title": "EMA concludes review of weight management medicine Mysimba", "press_release": "No", "related_medicine_referral": "Mysimba", "categories": "Human", "topics": "Referrals", "news_summary": "Benefits continue to outweigh risks, with new risk minimisation measures and more information to be provided about long-term effect on the heart", "first_published_date": "28/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-concludes-review-weight-management-medicine-mysimba" }, { "title": "EMA establishes regular procedure for scientific advice on certain high-risk medical devices", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medical devices", "news_summary": "Manufacturers can request advice on their medical device clinical development programme", "first_published_date": "10/02/2025", "last_updated_date": "24/03/2025", "news_url": "https://www.ema.europa.eu/en/news/ema-establishes-regular-procedure-scientific-advice-certain-high-risk-medical-devices" }, { "title": "EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH) in biopsy samples", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials;Medicines", "news_summary": "Artificial intelligence tool reliably identifies disease severity and reduces variability", "first_published_date": "20/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-qualifies-first-artificial-intelligence-tool-diagnose-inflammatory-liver-disease-mash-biopsy-samples" }, { "title": "Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance;Medicines", "news_summary": "Seizing opportunities in a changing medicines landscape", "first_published_date": "18/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/joint-strategy-sets-direction-ema-eu-medicines-regulatory-agencies-2028" }, { "title": "First vaccine against epizootic haemorrhagic disease recommended for approval", "press_release": "No", "related_medicine_referral": "Hepizovac", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "The vaccine will protect cattle from outbreaks, protect animal health and prevent economic losses", "first_published_date": "14/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-vaccine-against-epizootic-haemorrhagic-disease-recommended-approval" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 March 2025", "press_release": "No", "related_medicine_referral": "Hepizovac;Nobilis Multriva RT+IBm+ND+EDS;Prazivetin;Prevestrus vet;Rheumocam;Osurnia;Bravecto;Forceris;Porcilis ColiClos;Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli);Porcilis AR-T DF;Sevohale (previously Sevocalm);Quadrisol;Sevohale (previously Sevocalm);Veraflox", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "14/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-11-13-march-2025" }, { "title": "EMA Management Board: highlights of March 2025 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Clinical trials;Governance", "news_summary": "EMA annual report 2024 and network strategy to 2028 adopted", "first_published_date": "14/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2025-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 March 2025", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use", "first_published_date": "14/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-march-2025" }, { "title": "Unregulated advanced therapy medicinal products pose serious risks to health", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies", "news_summary": "Authorities warn about unregulated products in the EU, including dendritic cell cancer therapies", "first_published_date": "13/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/unregulated-advanced-therapy-medicinal-products-pose-serious-risks-health" }, { "title": "EMA Management Board elects new chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "Rui Santos Ivo elected for three-year term", "first_published_date": "13/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-elects-new-chair" }, { "title": "New clinical trial map launched in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "Patients can locate trials for potential enrolment in their area", "first_published_date": "03/03/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-clinical-trial-map-launched-eu" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025", "press_release": "No", "related_medicine_referral": "Imfinzi;Dupixent;Rinvoq;Keytruda;Trabectedin Accord;Tremfya;Pelgraz Paediatric;Enhertu;Stelara;Kaftrio;Bimervax;Vyjuvek;Fabhalta;Deqsiga;Rilonacept FGK Representative Service GmbH ;Prevymis;Supemtek Tetra (previously Supemtek);Ixchiq;Calquence;Abrysvo;Leqembi;Jaypirca;Darzalex;Columvi", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications", "first_published_date": "28/02/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-february-2025" }, { "title": "First topical gene therapy treatment for dystrophic epidermolysis bullosa", "press_release": "No", "related_medicine_referral": "Vyjuvek", "categories": "Human", "topics": "Medicines", "news_summary": "Vyjuvek expected to bring substantial therapeutic benefits and improve quality of life for patients with ultra-rare genetic skin disorder", "first_published_date": "28/02/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-topical-gene-therapy-treatment-dystrophic-epidermolysis-bullosa" }, { "title": "Combination of cystic fibrosis medicines to treat patients with rare mutations", "press_release": "No", "related_medicine_referral": "Kaftrio;Kalydeco", "categories": "Human", "topics": "Medicines", "news_summary": "Positive opinion for extension of indication brings disease-modifying treatment to all cystic fibrosis patients with modulator responsive mutations", "first_published_date": "28/02/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/combination-cystic-fibrosis-medicines-treat-patients-rare-mutations" }, { "title": "EMA earns certification for its environmental efforts", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "Eco-Management and Audit Scheme (EMAS) certificate is a mark of environmental excellence in the EU", "first_published_date": "17/02/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-earns-certification-its-environmental-efforts" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-12 February 2025", "press_release": "No", "related_medicine_referral": "Omeprazole TriviumVet;Elmaro;Vectormune HVT-AIV;Porcilis ColiClos;Simparica Trio;Bluevac BTV (previously Bluevac BTV8);Porcilis ColiClos;Strangvac;Suvaxyn PRRS MLV;Cardalis;Clevor;Fortekor Plus;Hydrocortisone aceponate Ecuphar (previously Cortacare);Increxxa;Ingelvac CircoFLEX;ProZinc;ReproCyc ParvoFLEX;Sileo;Sedadex", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "14/02/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-11-12-february-2025" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use", "first_published_date": "14/02/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-february-2025" }, { "title": "Clinical Trials Regulation becomes fully applicable", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "Clinical Trials Information System now supports submission, assessment and oversight of all trials in the EU", "first_published_date": "31/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/clinical-trials-regulation-becomes-fully-applicable" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025", "press_release": "No", "related_medicine_referral": "Capvaxive;Datroway;Tivdak;Vimkunya;Dyrupeg;Pavblu;Skojoy;Eltrombopag Accord;Breyanzi;Imfinzi;Ronapreve;Rxulti;Sivextro;Slenyto;Opdivo;Yervoy;Ivermectin/Albendazole;Datopotamab deruxtecan Daiichi Sankyo;Nugalviq;Leqembi", "categories": "Human", "topics": "Medicines;Medicines for use outside the EU", "news_summary": "Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the EU", "first_published_date": "31/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-january-2025" }, { "title": "New Chikungunya vaccine for adolescents from 12 and adults", "press_release": "No", "related_medicine_referral": "Vimkunya", "categories": "Human", "topics": "Medicines", "news_summary": "The review of Vimkunya was expedited because of public health interest", "first_published_date": "31/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-chikungunya-vaccine-adolescents-12-adults" }, { "title": "New combination of medicines to treat parasitic worm infections", "press_release": "No", "related_medicine_referral": "Ivermectin/Albendazole", "categories": "Human", "topics": "Medicines;Medicines for use outside the EU", "news_summary": "EMA opinion for ivermectin and albendazole supports global efforts to eliminate widespread infections", "first_published_date": "31/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-combination-medicines-treat-parasitic-worm-infections" }, { "title": "One Health: EU agencies unite to tackle azole fungicide resistance in Aspergillus fungi", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Medicines", "news_summary": "The extensive use of azole fungicides (azoles), particularly in some agricultural and horticultural practices, can increase the risk of Aspergillus fungi developing resistance to essential antifungal treatments. This significant finding is highlighted in a report by the five EU health and environment agencies, with support from the European Commission’s Joint Research Centre (JRC). The Agencies collaborated under a One Health approach to address this growing threat.", "first_published_date": "30/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/one-health-eu-agencies-unite-tackle-azole-fungicide-resistance-aspergillus-fungi" }, { "title": "European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "Reporting of medicine shortages by marketing authorisation holders and regulators in one single platform", "first_published_date": "29/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-shortages-monitoring-platform-fully-operational-monitoring-shortages-eu" }, { "title": "EMA celebrates 30 years of progress in science and medicines in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "Agency marks milestone highlighting its changing role in Europe", "first_published_date": "27/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-celebrates-30-years-progress-science-medicines-european-union" }, { "title": "Veterinary medicines in 2024", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "25 new medicines recommended for approval; two with a new active substance", "first_published_date": "23/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-2024" }, { "title": "Two new vaccines against bluetongue recommended for approval", "press_release": "No", "related_medicine_referral": "Bluevac-3;Syvazul BTV 3", "categories": "Veterinary", "topics": "Medicines", "news_summary": "These vaccines will protect sheep and cattle from disease outbreaks of newly emerged serotype-3", "first_published_date": "17/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/two-new-vaccines-against-bluetongue-recommended-approval" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 January 2025", "press_release": "No", "related_medicine_referral": "Bluevac-3;Syvazul BTV 3;Nobilis Multriva REOm;Nobivac Bb;Porcilis AR-T DF;Porcilis ColiClos;Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "17/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-14-15-january-2025" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2025", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products;Ozempic;Rybelsus;Wegovy", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "Investigation of risk of rare eye condition with semaglutide medicines", "first_published_date": "17/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-january-2025" }, { "title": "Human medicines in 2024", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines;Medicines", "news_summary": "114 new medicines recommended for approval; 46 had a new active substance", "first_published_date": "16/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-2024" }, { "title": "Revised rules on handling of competing interests published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "Updated policies for committee members, experts and Management Board members effective from May 2025", "first_published_date": "14/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/revised-rules-handling-competing-interests-published" }, { "title": "New EU rules for health technology assessments become effective", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies", "news_summary": "Enhanced EU collaboration to allow faster and wider access to innovative health technologies", "first_published_date": "10/01/2025", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-eu-rules-health-technology-assessments-become-effective" }, { "title": "A common EU approach to data transparency in medicine regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "EMA and HMA update principles for identification and disclosure of commercially confidential information and personal data", "first_published_date": "18/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/common-eu-approach-data-transparency-medicine-regulation" }, { "title": "Emer Cooke, EMA’s Executive Director: 2024 achievements in medicine regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "EMA's Executive Director shares her end-of-year message and takes stock of EMA's work in 2024", "first_published_date": "17/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emer-cooke-emas-executive-director-2024-achievements-medicine-regulation" }, { "title": "EMA business hours over holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on 19 December 2024 to 08:30 on 6 January 2025", "first_published_date": "17/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-holiday-period-1" }, { "title": "Successful pilot paves the way for implementation of ePI", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Product information", "news_summary": "Report outlines recommendations and next steps", "first_published_date": "16/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/successful-pilot-paves-way-implementation-epi" }, { "title": "EMA Management Board: highlights of December 2024 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate;Clinical trials;Fees;Medicine shortages", "news_summary": "Work programme and budget for 2025 among other topics", "first_published_date": "13/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2024-meeting" }, { "title": "First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome", "press_release": "No", "related_medicine_referral": "Emcitate", "categories": "Human", "topics": "Medicines", "news_summary": "Emcitate can be used in patients of all ages", "first_published_date": "13/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-peripheral-thyrotoxicosis-patients-allan-herndon-dudley-syndrome" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2024", "press_release": "No", "related_medicine_referral": "Andembry;Beyonttra;Kavigale;Kostaive;Nemluvio;Paxneury;Rytelo;Welireg;Avtozma;Eydenzelt;Osenvelt;Yesintek;Zefylti;Stoboclo;Emcitate;Tuzulby;Blincyto;Bridion;Flucelvax Tetra;Jemperli;Ofev;Omvoh;Rekambys;Vocabria;Cinainu;Kizfizo;Keytruda;Evusheld;Regkirona;Alofisel;Ronapreve;Xevudy;Mounjaro;Bamlanivimab and etesevimab for COVID-19", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "Seventeen new medicines recommended for approval; another eight medicines recommended for extension of their therapeutic indications", "first_published_date": "13/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-9-12-december-2024" }, { "title": "First medicine to treat rare genetic disorder causing cysts and tumours", "press_release": "No", "related_medicine_referral": "Welireg", "categories": "Human", "topics": "Medicines", "news_summary": "Oral medicine to treat two different conditions, rare von Hippel-Lindau disease and advanced clear cell renal cell carcinoma", "first_published_date": "13/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-medicine-treat-rare-genetic-disorder-causing-cysts-tumours" }, { "title": "Alofisel withdrawn from the EU market", "press_release": "No", "related_medicine_referral": "Alofisel", "categories": "Human", "topics": "Medicines", "news_summary": "Benefit of medicine used in Crohn’s disease no longer demonstrated", "first_published_date": "13/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/alofisel-withdrawn-eu-market" }, { "title": "First treatment recommended for rare progressive lung conditions in children and adolescents", "press_release": "No", "related_medicine_referral": "Ofev", "categories": "Human", "topics": "Medicines", "news_summary": "Positive opinion for extension of indication from age of six", "first_published_date": "13/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-recommended-rare-progressive-lung-conditions-children-adolescents" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 December 2024", "press_release": "No", "related_medicine_referral": "Icthiovac ERM;Poulvac Procerta HVT-IBD-ND ;Tolfenamic acid VMD;Librela;Cerenia;NexGard Combo;Prevexxion RN+HVT;Prevexxion RN+HVT+IBD;Prevexxion RN;Bonqat;Ecoporc Shiga;Pexion;Vectra 3D", "categories": "Veterinary", "topics": "Maximum residue limit;Medicines;Vaccines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting", "first_published_date": "06/12/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-3-5-december-2024" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "Doxycycline: currently available evidence not supporting link with risk of suicidality", "first_published_date": "29/11/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-november-2024" }, { "title": "European Shortages Monitoring Platform enables better monitoring of shortages in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicine shortages", "news_summary": "Marketing authorisation holders can now use the platform to report shortages of centrally authorised human medicines.", "first_published_date": "28/11/2024", "last_updated_date": "28/11/2024", "news_url": "https://www.ema.europa.eu/en/news/european-shortages-monitoring-platform-enables-better-monitoring-shortages-eu" }, { "title": "EMA encourages companies to submit type I variations for 2024 by end November 2024", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Medicines", "news_summary": "EMA is advising marketing authorisation holders to submit type I variations for 2024 no later than 30 November 2024.", "first_published_date": "15/11/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-encourages-companies-submit-type-i-variations-2024-end-november-2024-0" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024", "press_release": "No", "related_medicine_referral": "Augtyro;Gohibic;Lazcluze;Ahzantive;Baiama;Obodence;Xbryk;CellCept;Evkeeza;Jakavi;Kevzara;Keytruda;Opdivo;Palforzia;Rybrevant;Sarclisa;Tagrisso;Yervoy;Cinainu;Kizfizo;Inaqovi;Izelvay;Leqembi;Mysimba", "categories": "Human", "topics": "Medicines", "news_summary": "Leqembi (lecanemab) recommended for treatment of early Alzheimer’s disease", "first_published_date": "15/11/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-november-2024" }, { "title": "Updated advice to minimise risks of interaction between weight loss medicine Mysimba and opioids", "press_release": "No", "related_medicine_referral": "Mysimba", "categories": "Human", "topics": "Medicines", "news_summary": "Use of opioid medicines with Mysimba may lead to serious side effects", "first_published_date": "15/11/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/updated-advice-minimise-risks-interaction-between-weight-loss-medicine-mysimba-opioids" }, { "title": "EMA encourages companies to submit type I variations for 2024 by end November 2024", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "15/11/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-encourages-companies-submit-type-i-variations-2024-end-november-2024" }, { "title": "Leqembi recommended for treatment of early Alzheimer’s disease", "press_release": "No", "related_medicine_referral": "Leqembi", "categories": "Human", "topics": "Medicines", "news_summary": "Re-examination concludes that benefits outweigh risks in a restricted patient population", "first_published_date": "14/11/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/leqembi-recommended-treatment-early-alzheimers-disease" }, { "title": "First certification of a veterinary vaccine platform technology master file", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "Platform technologies enable rapid response to emerging infectious disease threats", "first_published_date": "08/11/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-certification-veterinary-vaccine-platform-technology-master-file" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 November 2024", "press_release": "No", "related_medicine_referral": "Carprofen Orion;MS-H Vaccine;Simparica Trio;Baycox Iron;Eurican L4;Rabitec;RenuTend;Equisolon;Rexxolide", "categories": "Veterinary", "topics": "Maximum residue limit;Medicines;Vaccines", "news_summary": "", "first_published_date": "08/11/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-5-7-november-2024" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2024", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use", "first_published_date": "31/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-31-october-2024" }, { "title": "EMA closed 1 November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed on Friday 1 November 2024 for All Saints’ Day.", "first_published_date": "30/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-1-november" }, { "title": "Fostering regulatory collaboration to improve access to mpox medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials;Medicines;Vaccines", "news_summary": "Global regulators discuss available knowledge supporting mpox medicine development and approval", "first_published_date": "25/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/fostering-regulatory-collaboration-improve-access-mpox-medicines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024", "press_release": "No", "related_medicine_referral": "Alhemo;Fluad;Flucelvax;Korjuny;Siiltibcy;Wainzua;Absimky;Imuldosa;Buprenorphine Neuraxpharm;Eltrombopag Viatris;Cerdelga;Hepcludex;Kevzara;Kisqali;Tevimbra;Yselty;Masitinib AB Science;Translarna;Epixram", "categories": "Human", "topics": "Medicines", "news_summary": "Ten new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications", "first_published_date": "18/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2024" }, { "title": "Translarna: EMA re-confirms non-renewal of authorisation of Duchenne muscular dystrophy medicine", "press_release": "No", "related_medicine_referral": "Translarna", "categories": "Human", "topics": "Medicines", "news_summary": "Re-examination concludes effectiveness has not been confirmed", "first_published_date": "18/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/translarna-ema-re-confirms-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 October 2024", "press_release": "No", "related_medicine_referral": "Duotic;Bravecto TriUNO;Vaxxon ND Clone ;Bovela;Cortavance;Easotic;Enteroporc Coli AC;Poulvac Procerta HVT-IBD;Zycortal;Bovilis Nasalgen-C;Eluracat;Mometamax Ultra", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "11/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-8-10-october-2024" }, { "title": "Handling of competing interests: revised rules for committee members and experts", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "Public consultation on updated policy to run until 10 November 2024", "first_published_date": "10/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/handling-competing-interests-revised-rules-committee-members-experts" }, { "title": "Seizing opportunities in a changing medicines landscape", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "European medicines agencies network strategy to 2028 – launch of public consultation", "first_published_date": "09/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/seizing-opportunities-changing-medicines-landscape" }, { "title": "EMA Management Board: highlights of October 2024 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "Board elects new vice-chair and endorses draft network strategy to 2028 for public consultation", "first_published_date": "04/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2024-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 September-3 October 2024", "press_release": "No", "related_medicine_referral": "Finasteride- and dutasteride-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "Review of medicines containing finasteride and dutasteride started", "first_published_date": "04/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-30-september-3-october-2024" }, { "title": "Improving efficiency of approval process for new medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "Measures to optimise use of the EU's expert resources for faster assessments", "first_published_date": "02/10/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/improving-efficiency-approval-process-new-medicines-eu" }, { "title": "EMA recommends suspension of sickle cell disease medicine Oxbryta", "press_release": "No", "related_medicine_referral": "Oxbryta;Oxbryta", "categories": "Human", "topics": "Medicines", "news_summary": "Measure taken as precaution while review of emerging data is ongoing", "first_published_date": "26/09/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-suspension-sickle-cell-disease-medicine-oxbryta" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2024", "press_release": "No", "related_medicine_referral": "Elahere;Hetronifly;Hympavzi;Penbraya;Theralugand;Afqlir;Buccolam;Pomalidomide Teva;Opuviz;Syfovre;Darzalex;Dupixent;Esperoct;Fasenra;Imvanex;Keytruda;Otezla;Pravafenix;Synjardy;Zavicefta;Durysta;Tecentriq;Sialanar", "categories": "Human", "topics": "Medicines", "news_summary": "8 new medicines recommended for approval; another 12 medicines recommended for extension of their therapeutic indications", "first_published_date": "20/09/2024", "last_updated_date": "23/09/2024", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-september-2024" }, { "title": "EMA recommends extending indication of mpox vaccine to adolescents", "press_release": "No", "related_medicine_referral": "Imvanex", "categories": "Human", "topics": "Mpox;Medicines", "news_summary": "Vaccine assessment can support African regulators in fight against ongoing outbreak", "first_published_date": "19/09/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-extending-indication-mpox-vaccine-adolescents" }, { "title": "EMA’s human medicines committee elects new Chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Medicines", "news_summary": "Bruno Sepodes begins his three-year mandate on 21 September 2024", "first_published_date": "18/09/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emas-human-medicines-committee-elects-new-chair" }, { "title": "New chair elected for EMA’s Orphan Medicinal Products Committee", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "Tim Leest begins his three-year mandate on 16 September", "first_published_date": "16/09/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-chair-elected-emas-orphan-medicinal-products-committee" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 September 2024", "press_release": "No", "related_medicine_referral": "ArthriCox;Cirbloc M Hyo;NexGard Combo;Yurvac RHD;Cerenia;Locatim (previously Serinucoli);Mhyosphere PCV ID;Panacur AquaSol;Profender;Respiporc Flu3;Simparica;Simparica Trio;Solensia;Strangvac;Suvaxyn PRRS MLV;Zenalpha;Neptra", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "13/09/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-10-12-september-2024" }, { "title": "EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole", "press_release": "No", "related_medicine_referral": "Metamizole-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "Product information to be updated to raise awareness of known risk of agranulocytosis and facilitate its early detection and diagnosis", "first_published_date": "06/09/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-measures-minimise-serious-outcomes-known-side-effect-painkiller-metamizole" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024", "press_release": "No", "related_medicine_referral": "Metamizole-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole", "first_published_date": "06/09/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-september-2024" }, { "title": "Harnessing AI in medicines regulation: use of large language models (LLMs)", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "Guiding principles set out how EU medicine regulators can use LLMs in a safe, responsible and effective manner", "first_published_date": "05/09/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/harnessing-ai-medicines-regulation-use-large-language-models-llms" }, { "title": "EMA is closed on Assumption Day, 15 August", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "The European Medicines Agency's (EMA) office is closed on Thursday 15 August 2024.", "first_published_date": "13/08/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-assumption-day-15-august" }, { "title": "New pilot programme to support orphan medical devices", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medical devices", "news_summary": "Free advice and guidance available for manufacturers and notified bodies", "first_published_date": "02/08/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-pilot-programme-support-orphan-medical-devices" }, { "title": "EMA supports pilot for joint African continental assessment procedures", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "Validating processes is an important step towards establishment of African Medicines Agency", "first_published_date": "30/07/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-supports-pilot-joint-african-continental-assessment-procedures" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024", "press_release": "No", "related_medicine_referral": "Anzupgo;Iqirvo;Loqtorzi;Vevizye;Vyloy;Yuvanci;Axitinib Accord;Eksunbi;Fymskina;Hervelous;Ituxredi;Otulfi;Epruvy (previously Ranibizumab Midas);Leqembi;Arexvy;Braftovi;Edurant;Keytruda;Mektovi;Opsumit;Padcev;Rybrevant;Slenyto;Spevigo;Tecentriq;Masitinib AB Science;Syfovre;Translarna;Wegovy;Mysimba;Kayfanda", "categories": "Human", "topics": "Medicines", "news_summary": "14 new medicines recommended for approval; another 11 medicines recommended for extension of therapeutic indications", "first_published_date": "26/07/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2024" }, { "title": "EMA advises about risks of using weight loss medicine Mysimba with opioids", "press_release": "No", "related_medicine_referral": "Mysimba", "categories": "Human", "topics": "Medicines", "news_summary": "Use of opioid medicines with Mysimba may lead to serious side effects", "first_published_date": "26/07/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-advises-about-risks-using-weight-loss-medicine-mysimba-opioids" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 July 2024", "press_release": "No", "related_medicine_referral": "Cevac Salmune ETI K;Porcilis PCV M Hyo ID;Cepeloron;Senvelgo;Eluracat;Vectormune ND;Versican Plus Pi/L4R;Versican Plus DHPPi/L4;Versican Plus Pi/L4;Versican Plus Pi/L4R;Versican Plus L4;Clomicalm;Posatex", "categories": "Veterinary", "topics": "Medicines", "news_summary": "Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting.", "first_published_date": "19/07/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-16-18-july-2024" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024", "press_release": "No", "related_medicine_referral": "Metamizole-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "PRAC elects new chair", "first_published_date": "12/07/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-july-2024" }, { "title": "EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna", "press_release": "No", "related_medicine_referral": "Translarna", "categories": "Human", "topics": "Referrals", "news_summary": "Opinion follows review of additional data and advice from group of experts.", "first_published_date": "28/06/2024", "last_updated_date": "11/07/2024", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna-0" }, { "title": "EMA’s safety committee elects new chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "Ulla Wändel Liminga will begin her three-year mandate in September 2024", "first_published_date": "11/07/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emas-safety-committee-elects-new-chair" }, { "title": "Recent additions to EMA’s management team", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "New appointments in the Legal Department and the Regulatory Science and Innovation Task Force", "first_published_date": "04/07/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/recent-additions-emas-management-team" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024", "press_release": "No", "related_medicine_referral": "Balversa;Eurneffy;mResvia;Ordspono;Piasky;Tauvid;Winrevair;Steqeyma;Enzalutamide Viatris;Nilotinib Accord;Masitinib AB Science;Syfovre;Translarna;Betmiga;Beyfortus;Cresemba;Imfinzi;Imcivree;Infanrix Hexa;Lynparza;Pegasys;Tepkinly;Vabysmo;Xalkori;Dabigatran etexilate Teva ;Ocaliva;Havrix;Lorazepam Macure 4 mg/ml, solution for injection", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "10 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications", "first_published_date": "28/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024" }, { "title": "Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension", "press_release": "No", "related_medicine_referral": "Winrevair", "categories": "Human", "topics": "Medicines", "news_summary": "Winrevair received support through PRIority Medicines (PRIME) scheme due to its potential to bring a major therapeutic advantage over existing therapies", "first_published_date": "28/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/positive-chmp-opinion-first-class-medicine-treat-pulmonary-arterial-hypertension" }, { "title": "EMA recommends revoking conditional marketing authorisation for Ocaliva", "press_release": "No", "related_medicine_referral": "Ocaliva;Ocaliva", "categories": "Human", "topics": "Referrals", "news_summary": "Benefits of Ocaliva no longer considered to outweigh its risks", "first_published_date": "28/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-revoking-conditional-marketing-authorisation-ocaliva" }, { "title": "First nasal adrenaline spray for emergency treatment against allergic reactions", "press_release": "No", "related_medicine_referral": "Eurneffy", "categories": "Human", "topics": "", "news_summary": "Eurneffy (epinephrine) is an alternative to injectable formulations", "first_published_date": "28/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-nasal-adrenaline-spray-emergency-treatment-against-allergic-reactions" }, { "title": "EU actions to tackle shortages of GLP-1 receptor agonists", "press_release": "No", "related_medicine_referral": "Ozempic;Saxenda;Trulicity;Victoza", "categories": "Human", "topics": "Medicine shortages", "news_summary": "MSSG recommendations for all stakeholders and upcoming multistakeholder workshop", "first_published_date": "26/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-actions-tackle-shortages-glp-1-receptor-agonists" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-19 June 2024", "press_release": "No", "related_medicine_referral": "Divence IBR Marker Live;Daxocox;Suvaxyn PRRS MLV;Rabitec;Credelio;AdTab (previously Lotilaner Elanco);Stronghold Plus;Neptra", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "21/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-18-19-june-2024" }, { "title": "Faster access to clinical trial information in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "Revised rules for Clinical Trials Information System (CTIS) become applicable", "first_published_date": "18/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe" }, { "title": "Review of painkiller metamizole started", "press_release": "No", "related_medicine_referral": "Metamizole-containing medicinal products", "categories": "Human", "topics": "Referrals", "news_summary": "Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to minimise it.", "first_published_date": "14/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/review-painkiller-metamizole-started" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024", "press_release": "No", "related_medicine_referral": "Abecma;Breyanzi;Carvykti;Kymriah;Tecartus;Yescarta;Metamizole-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "Start of review of painkiller metamizole and risk of secondary cancers with CAR T-cell medicines.", "first_published_date": "14/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-june-2024" }, { "title": "EMA Management Board: highlights of June 2024 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Clinical trials;Fees;Medicine shortages", "news_summary": "Board adopts Executive Director’s annual activity report for 2023 and hears updates on implementation of new fee regulation.", "first_published_date": "14/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2024-meeting" }, { "title": "Two new advice pilots to improve clinical trials in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "Pilots are part of ACT EU collaboration to foster high-quality clinical research in the EU.", "first_published_date": "10/06/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/two-new-advice-pilots-improve-clinical-trials-europe" }, { "title": "EU recommendations for 2024/2025 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024.", "first_published_date": "26/03/2024", "last_updated_date": "03/06/2024", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2024-2025-seasonal-flu-vaccine-composition" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024", "press_release": "No", "related_medicine_referral": "Adzynma;Akantior;Cejemly;Beqvez (previously Durveqtix);Fluenz;GalliaPharm;Ixchiq;Zegalogue;Avzivi;Apexelsin;Dasatinib Accord Healthcare;Pomalidomide Accord;Pomalidomide Krka;Pomalidomide Zentiva;Dupixent;Eliquis;Kinpeygo;Livmarli;Skyrizi;Tagrisso;Tevimbra;Valdoxan;Kinharto;Scenesse", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "14 new medicines recommended for approval; another seven medicines are recommended for extension of their therapeutic indications", "first_published_date": "31/05/2024", "last_updated_date": "31/05/2024", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-may-2024" }, { "title": "First vaccine to protect adults from Chikungunya", "press_release": "No", "related_medicine_referral": "Ixchiq", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "Ixchiq was assessed under the OPEN framework to promote global public health", "first_published_date": "31/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-vaccine-protect-adults-chikungunya" }, { "title": "New gene therapy treatment for haemophilia B", "press_release": "No", "related_medicine_referral": "Beqvez (previously Durveqtix)", "categories": "Human", "topics": "Medicines", "news_summary": "Durveqtix received support through the PRIority Medicines (PRIME) scheme due to its potential to improve patients’ quality of life", "first_published_date": "31/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-gene-therapy-treatment-haemophilia-b" }, { "title": "Annual report highlights progress in science, medicines and health in 2023", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "", "news_summary": "EMA publishes 2023 annual report", "first_published_date": "30/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/annual-report-highlights-progress-science-medicines-health-2023" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May 2024", "press_release": "No", "related_medicine_referral": "Nobilis Multriva RT+IBm+ND+EDS;Nobilis Multriva RT+IBm+ND+Gm+REOm;Bluevac BTV (previously Bluevac BTV8);Contacera;Felpreva;Locatim (previously Serinucoli);MS-H Vaccine;Nobivac LoVo L4;Rabitec;Tulissin;Circovac;Forceris;Isemid;Porcilis AR-T DF;Vectra Felis;Vectra 3D;Virbagen Omega", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "24/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-21-22-may-2024" }, { "title": "EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna", "press_release": "No", "related_medicine_referral": "Translarna", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/01/2024", "last_updated_date": "21/05/2024", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-recommendation-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna" }, { "title": "Medical devices: new guidance for industry and notified bodies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medical devices", "news_summary": "Question-and-answer document clarifies regulatory requirements for devices used in combination with medicines", "first_published_date": "21/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/medical-devices-new-guidance-industry-notified-bodies" }, { "title": "Have your say and help shape EMA’s future communications", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "EMA launches fifth communication perception survey", "first_published_date": "21/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/have-your-say-help-shape-emas-future-communications" }, { "title": "European medicines network designated as WHO listed authority", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Regulatory Network (EMRN) has been designated as WHO Listed Authority (WLA) by the World Health Organization (WHO).", "first_published_date": "20/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-network-designated-who-listed-authority" }, { "title": "Hydroxyprogesterone caproate medicines to be suspended from the EU market", "press_release": "No", "related_medicine_referral": "Hydroxyprogesterone caproate-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "Review of studies raises possible safety concern and finds no effect in preventing premature birth", "first_published_date": "17/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/hydroxyprogesterone-caproate-medicines-be-suspended-eu-market" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024", "press_release": "No", "related_medicine_referral": "Hydroxyprogesterone caproate-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "Hydroxyprogesterone caproate medicines to be suspended from the EU market", "first_published_date": "17/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-may-2024" }, { "title": "EMA closed on Whit Monday, 20 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on Friday 17 May 2024 to 07:30 on Tuesday 21 May 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.", "first_published_date": "16/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-whit-monday-20-may" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024", "press_release": "No", "related_medicine_referral": "Altuvoct;Fruzaqla;Jeraygo;Obgemsa;Truqap;Tocilizumab STADA (previously Tofidence);Wezenla;Eribulin Baxter;Alecensa;Opdivo;Rozlytrek;Rybrevant;Sirturo;Triumeq;Reyataz;GeGant;Syfovre;Upstelda", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.", "first_published_date": "26/04/2024", "last_updated_date": "07/05/2024", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024" }, { "title": "EMA closed 9-10 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on Wednesday 8 May 2024 to 07:30 on Monday 13 May 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.", "first_published_date": "07/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-9-10-may" }, { "title": "One Health: a joint framework for action published by five EU agencies", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "", "news_summary": "Today, the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).", "first_published_date": "07/05/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agencies" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 April 2024", "press_release": "No", "related_medicine_referral": "Respivac aMPV (previously Respivac TRT);Coxatab;Coxevac;Evant;Simparica Trio;Advocate;Arti-Cell Forte;Convenia;Cortavance;MS-H Vaccine;Neoleish;NexGard;Syvazul BTV;Tessie;UpCard;Innovax-ND-H5", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/04/2024", "last_updated_date": "30/04/2024", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-16-18-april-2024" }, { "title": "ETF recommends updating COVID-19 vaccines to target new JN.1 variant", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "Updated vaccines will help maintain protection against disease as virus continues to evolve.", "first_published_date": "30/04/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant" }, { "title": "EMA closed 1 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:00 on Tuesday 30 April 2024 to 07:30 on Thursday 2 May 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.", "first_published_date": "29/04/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-1-may" }, { "title": "Confidentiality arrangement between the EU and the Republic of Korea", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a working arrangement with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for the exchange of confidential information on medical and medicinal products.", "first_published_date": "26/04/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/confidentiality-arrangement-between-eu-republic-korea" }, { "title": "New recommendations to strengthen supply chains of critical medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.", "first_published_date": "23/04/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-recommendations-strengthen-supply-chains-critical-medicines" }, { "title": "COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "Report on COVID-19 vaccine strain updates: global regulators agree on timing and data requirements", "first_published_date": "17/04/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-strain-updates-global-regulators-agree-timing-data-requirements" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024", "press_release": "No", "related_medicine_referral": "Hydroxyprogesterone caproate-containing medicinal products;Ozempic;Rybelsus;Wegovy;Victoza;Saxenda;Xultophy;Byetta;Bydureon;Lyxumia;Suliqua;Trulicity", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "GLP-1 receptor agonists: available evidence not supporting link with suicidal and self-injurious thoughts and actions", "first_published_date": "12/04/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024" }, { "title": "EMA systems disruption expected from 11 to 17 April", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "Due to planned system maintenance, several EMA applications will be fully or partially inaccessible from 11 to 17 April.", "first_published_date": "08/04/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-systems-disruption-expected-11-17-april" }, { "title": "Regulatory information – adjusted fees for applications to EMA from 1 April 2024", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2024.", "first_published_date": "27/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2024" }, { "title": "EMA business hours over Easter holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 27 March 2024 to 07:30 on Tuesday 2 April 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.", "first_published_date": "26/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-easter-holiday-period" }, { "title": "EMA Management Board: highlights of March 2024 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Corporate;Clinical trials;Fees", "news_summary": "Outcomes of the EMA Management Board meeting. The Management Board is an integral governance body of the Agency.", "first_published_date": "22/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2024-meeting" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024", "press_release": "No", "related_medicine_referral": "Awiqli;Emblaveo;Fabhalta;Lytenava;Jubbonti;Omlyclo;Wyost;Agilus;Neoatricon;Dimethyl fumarate Accord;Dimethyl fumarate Mylan;Dimethyl fumarate Neuraxpharm;Bimzelx;Nilemdo;Nustendi;Onivyde pegylated liposomal (previously Onivyde);Retsevmo;Xtandi;Adcetris;Ongentys;Ontilyv;Orencia;Synapse;Micrazym and associated names;Syfovre", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.", "first_published_date": "22/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-march-2024" }, { "title": "New antibiotic to fight infections caused by multidrug-resistant bacteria", "press_release": "No", "related_medicine_referral": "Emblaveo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-antibiotic-fight-infections-caused-multidrug-resistant-bacteria" }, { "title": "First oral monotherapy for patients with paroxysmal nocturnal haemoglobinuria", "press_release": "No", "related_medicine_referral": "Fabhalta", "categories": "Human", "topics": "Medicines", "news_summary": "EMA has recommended granting a marketing authorisation in the European Union (EU) for Fabhalta (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.", "first_published_date": "22/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-oral-monotherapy-patients-paroxysmal-nocturnal-haemoglobinuria" }, { "title": "Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU).", "first_published_date": "20/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/accelerating-stakeholder-collaboration-enhance-clinical-trials-environment-eu" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-13 March 2024", "press_release": "No", "related_medicine_referral": "Divence Tetra;Trilocur;Trilorale;Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS;Lotimax;Prevexxion RN+HVT+IBD;Respiporc FLUpan H1N1;Senvelgo;Bovela;Aivlosin;Coliprotec F4/F18;Eurican Herpes 205;Halocur;Nobilis IB Primo QX;Purevax RCP;Purevax RCP FeLV;Respiporc FLUpan H1N1;Suiseng Diff/A;Tulaven;Zulvac BTV", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "18/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-12-13-march-2024" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Medicines;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "08/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-march-2024" }, { "title": "DARWIN EU® continues expanding its capacity to deliver real-world data studies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.", "first_published_date": "06/03/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/darwin-eur-continues-expanding-its-capacity-deliver-real-world-data-studies" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024", "press_release": "No", "related_medicine_referral": "Celldemic;Filspari;Incellipan;Qalsody;Voydeya;Zynyz;Pyzchiva;Apremilast Accord;Nintedanib Accord;Nezglyal;Carvykti;Cibinqo;Kalydeco;Keytruda;Reblozyl;Xromi;Ibuprofen NVT", "categories": "Human", "topics": "Medicines;Referrals;Vaccines", "news_summary": "", "first_published_date": "23/02/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-february-2024" }, { "title": "New treatment for rare motor neurone disease recommended for approval", "press_release": "No", "related_medicine_referral": "Qalsody", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/02/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-rare-motor-neurone-disease-recommended-approval" }, { "title": "First oral treatment against residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria", "press_release": "No", "related_medicine_referral": "Voydeya", "categories": "Human", "topics": "Medicines", "news_summary": "EMA has recommended granting a marketing authorisation in the European Union (EU) for Voydeya, the first oral treatment for patients with paroxysmal nocturnal haemoglobinuria (PNH) who continue to have haemolytic anaemia (low levels of red blood cells) despite treatment with a C5 complement inhibitor (eculizumab or ravulizumab).", "first_published_date": "23/02/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-oral-treatment-against-residual-haemolytic-anaemia-patients-paroxysmal-nocturnal-haemoglobinuria" }, { "title": "Multi-agency report highlights importance of reducing antibiotic use", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Antimicrobial resistance", "news_summary": "Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria.", "first_published_date": "21/02/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/multi-agency-report-highlights-importance-reducing-antibiotic-use" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024", "press_release": "No", "related_medicine_referral": "Alcort;Divence Penta;Lexylan;Strangvac;Credelio;AdTab (previously Lotilaner Elanco);Aivlosin;Gumbohatch;Bovela;Daxocox;Increxxa;Librela;Profender;Syvazul BTV;Draxxin;Incurin;Lydaxx;OvuGel;Purevax RCP;Suprelorin;Syvazul BTV;Tulissin", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "16/02/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-13-14-february-2024" }, { "title": "Launch of new HMA-EMA catalogues of real-world data sources and studies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one for RWD studies.", "first_published_date": "15/02/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/launch-new-hma-ema-catalogues-real-world-data-sources-studies" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024", "press_release": "No", "related_medicine_referral": "Paxlovid", "categories": "Human", "topics": "COVID-19;Medicines;Pharmacovigilance;Referrals", "news_summary": "Paxlovid: reminder of serious adverse reactions when taken together with certain immunosuppressants", "first_published_date": "09/02/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-february-2024" }, { "title": "Progress update on pilot for academic and non-profit developers of advanced therapy medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Data on medicines", "news_summary": "Following the launch in September 2022, EMA has accepted three academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) into a pilot scheme, in which they benefit from enhanced support from the Agency.", "first_published_date": "08/02/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/progress-update-pilot-academic-non-profit-developers-advanced-therapy-medicines" }, { "title": "Clinical trials' transition to new EU system - one year left", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials;Medicines", "news_summary": "All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.", "first_published_date": "31/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/clinical-trials-transition-new-eu-system-one-year-left" }, { "title": "New platform for collection of sales and use data of antimicrobials in animals", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "EMA has just launched the new Antimicrobial Sales and Use (ASU) platform to support the collection of data by Member States on the sales and use of antimicrobials in animals.", "first_published_date": "29/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-platform-collection-sales-and-use-data-antimicrobials-animals" }, { "title": "EMA to support establishment of the African Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "EMA will harness its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network.", "first_published_date": "26/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-support-establishment-african-medicines-agency" }, { "title": "Precautionary measures to address potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines", "press_release": "No", "related_medicine_referral": "Valproate and related substances", "categories": "Human", "topics": "Referrals", "news_summary": "On 24 January 2024, the CMDh endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the 3 months before conception. Valproate medicines are used to treat epilepsy, bipolar disorders and, in some EU countries, migraine.", "first_published_date": "26/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/precautionary-measures-address-potential-risk-neurodevelopmental-disorders-children-born-men-treated-valproate-medicines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024", "press_release": "No", "related_medicine_referral": "Exblifep;Ryzneuta;Niapelf;Nezglyal;Abecma;Prevenar 20 (previously Apexxnar);Aspaveli;Beyfortus;Retsevmo;Translarna;Pseudoephedrine-containing medicinal products;Synapse;Aerinaze", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.", "first_published_date": "26/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-january-2024" }, { "title": "EMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine", "press_release": "No", "related_medicine_referral": "Aerinaze;Pseudoephedrine-containing medicinal products", "categories": "", "topics": "", "news_summary": "On 25 January 2024, EMA’s human medicines committee (CHMP) endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine.", "first_published_date": "26/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-measures-minimise-risk-serious-side-effects-medicines-containing-pseudoephedrine" }, { "title": "Veterinary medicines: Highlights of 2023", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "EMA has published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.", "first_published_date": "24/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2023" }, { "title": "Major update of the SME user guide", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Medicines;SME", "news_summary": "The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector. ", "first_published_date": "23/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/major-update-sme-user-guide" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-17 January 2024", "press_release": "No", "related_medicine_referral": "Metacam;Fevaxyn Pentofel;Suvaxyn CSF Marker;Suvaxyn PRRS MLV;Rexxolide;Moxidectin-containing veterinary medicines used in cattle, sheep and horses", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-16-17-january-2024" }, { "title": "Human medicines: highlights of 2023", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before.", "first_published_date": "16/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2023" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024", "press_release": "No", "related_medicine_referral": "Valproate and related substances", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures", "first_published_date": "12/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-january-2024" }, { "title": "Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures", "press_release": "No", "related_medicine_referral": "Valproate and related substances", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.", "first_published_date": "12/01/2024", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/potential-risk-neurodevelopmental-disorders-children-born-men-treated-valproate-medicines-prac-recommends-precautionary-measures" }, { "title": "Midterm report on 2025 network strategy highlights good progress during critical period of the pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The midterm report of the European Medicines Agencies Network Strategy finds the pandemic strengthened the network and supported transformative change in the European system across key strategic areas.", "first_published_date": "20/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/midterm-report-2025-network-strategy-highlights-good-progress-during-critical-period-pandemic" }, { "title": "EMA business hours over holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "The European Medicines Agency's (EMA) office is closed from Friday 22 December 2023 to Wednesday 3 January 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.", "first_published_date": "20/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-holiday-period-0" }, { "title": "Goodbye 2023: when optimism came back", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "EMA's Executive Director, Emer Cooke, shares her end-of-year message and takes stock of EMA's work in 2023.", "first_published_date": "19/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/goodbye-2023-when-optimism-came-back" }, { "title": "Artificial intelligence workplan to guide use of AI in medicines regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Data on medicines", "news_summary": "EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.", "first_published_date": "18/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation" }, { "title": "EMA Management Board: highlights of December 2023 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Corporate", "news_summary": "The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.", "first_published_date": "15/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2023-meeting" }, { "title": "First gene editing therapy to treat beta thalassemia and severe sickle cell disease", "press_release": "No", "related_medicine_referral": "Casgevy", "categories": "Human", "topics": "Medicines", "news_summary": "EMA has recommended approval of the first medicine using CRISPR/Cas9, a novel gene-editing technology. Casgevy (exagamglogene autotemcel) is indicated for the treatment of transfusion‑dependent beta thalassemia and severe sickle cell disease in patients 12 years of age and older for whom haematopoietic stem cell transplantation is appropriate and a suitable donor is not available.", "first_published_date": "15/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-gene-editing-therapy-treat-beta-thalassemia-and-severe-sickle-cell-disease" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023", "press_release": "No", "related_medicine_referral": "Casgevy;Skyclarys;Velsipity;Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma);Ibuprofen Gen.Orph;Mevlyq;Pomalidomide Viatris;HyQvia;Metalyse;VeraSeal;Zinplava;Blenrep;Fexinidazole Winthrop;Synapse", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.", "first_published_date": "15/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-december-2023" }, { "title": "New treatment for young children with parasitic disease schistosomiasis", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Arpraziquantel used to treat schistosomiasis in young children aged 3 months to 6 years.", "first_published_date": "15/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-young-children-parasitic-disease-schistosomiasis" }, { "title": "EMA confirms recommendation for non-renewal of authorisation of multiple myeloma medicine Blenrep", "press_release": "No", "related_medicine_referral": "Blenrep", "categories": "Human", "topics": "Medicines", "news_summary": "EMA’s human medicines committee (CHMP) has confirmed its initial recommendation to not renew the conditional marketing authorisation for Blenrep (belantamab mafodotin) because recent data did not confirm its effectiveness; the benefits of Blenrep are therefore considered to no longer outweigh its risks.", "first_published_date": "15/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-recommendation-non-renewal-authorisation-multiple-myeloma-medicine-blenrep" }, { "title": "Synapse Labs Pvt. Ltd: EMA recommends suspension of medicines over flawed studies", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India.", "first_published_date": "15/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/synapse-labs-pvt-ltd-ema-recommends-suspension-medicines-over-flawed-studies" }, { "title": "First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "The first version of the Union list of critical medicines contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU / EEA, for which continuity of supply is a priority and shortages should be avoided.", "first_published_date": "12/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-version-union-list-critical-medicines-agreed-help-avoid-potential-shortages-eu" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 December 2023", "press_release": "No", "related_medicine_referral": "Arti-Cell Forte;RenuTend;Bovilis Nasalgen-C;Nobilis IB 4-91;Porcilis AR-T DF;Nobilis IB Primo QX;Nobivac DP Plus;Porcilis ColiClos;Nobivac Bb;Nobivac Myxo-RHD Plus;Broadline;Solensia;Tulinovet;Vectra 3D;Zactran;Frontpro (previously Afoxolaner Merial)", "categories": "Veterinary", "topics": "Medicines", "news_summary": "The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bravecto (fluralaner) concerning the addition of a new pharmaceutical form, 150 mg/ml powder and solvent for suspension for injection, for dogs.", "first_published_date": "08/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-5-7-december-2023" }, { "title": "Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "Collaboration between medicines regulators is paving the way towards a global Pharmaceutical Quality Knowledge Management System (PQ KMS).", "first_published_date": "08/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-strengthen-efforts-ensure-continuous-availability-safe-and-high-quality-medicines" }, { "title": "Relaunched EMA website now live", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "The new website aims to help users find the information they need more easily.", "first_published_date": "05/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/relaunched-ema-website-now-live" }, { "title": "EU medicines agencies reflect on lessons learned from COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "The report reviews the response to the pandemic and highlights the main learnings for the future.", "first_published_date": "01/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-medicines-agencies-reflect-lessons-learned-covid-19" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023", "press_release": "No", "related_medicine_referral": "Pseudoephedrine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine.", "first_published_date": "01/12/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-november-2023" }, { "title": "Consumption of antimicrobials in animals reaches lowest level ever in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "European countries have substantially reduced sales of veterinary antibiotics.", "first_published_date": "20/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/consumption-antimicrobials-animals-reaches-lowest-level-ever-europe" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 November 2023", "press_release": "No", "related_medicine_referral": "Equioxx;Onsior;Simparica Trio;Felisecto Plus;MiPet Easecto;Simparica;Stronghold Plus;Vectormune ND;Newflend ND H9;Credelio Plus;Eravac;Eryseng;Eryseng Parvo;Evalon;Evant;Hiprabovis IBR Marker Live;Meloxoral;Mhyosphere PCV ID;Nasym;Nobivac LeuFel;Leucogen;Rhiniseng;Startvac;Suvaxyn Circo+MH RTU;Suvaxyn Circo;Ubac;Vepured", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "10/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-7-9-november-2023" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023", "press_release": "No", "related_medicine_referral": "Omjjara;Rystiggo;Uzpruvo;Azacitidine Kabi;Naveruclif;Vijoice;Krazati;Aspaveli;Ayvakyt;Evkeeza;Fluad Tetra;Jardiance;Keytruda;Mounjaro;NexoBrid;Talzenna;Xromi;Pradaxa;Veltassa;Rimmyrah;Bylvay", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "EMA’s human medicines committee (CHMP) recommended eight medicines.", "first_published_date": "10/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-6-9-november-2023" }, { "title": "Getting ready for EMA’s website relaunch on 5 December 2023", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "", "first_published_date": "09/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/getting-ready-emas-website-relaunch-5-december-2023" }, { "title": "Global regulators celebrate 10 years of strategic leadership and cooperation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "09/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-celebrate-10-years-strategic-leadership-and-cooperation" }, { "title": "First electronic product information (ePI) published for selected human medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Data on medicines;Product information", "news_summary": "", "first_published_date": "08/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-electronic-product-information-epi-published-selected-human-medicines" }, { "title": "EMA encourages companies to submit type I variations for 2023 in November 2023", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-encourages-companies-submit-type-i-variations-2023-november-2023" }, { "title": "Call for expressions of interest for patients’ organisations representatives to join Committee for Orphan Medicinal Products (COMP)", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/call-expressions-interest-patients-organisations-representatives-join-committee-orphan-medicinal-products-comp" }, { "title": "Call for expression of interest for independent scientific experts to participate in the work of EMA’s Safety Committee", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/11/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/call-expression-interest-independent-scientific-experts-participate-work-emas-safety-committee" }, { "title": "EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5", "press_release": "No", "related_medicine_referral": "Nuvaxovid", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "31/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-adapted-nuvaxovid-covid-19-vaccine-targeting-omicron-xbb15" }, { "title": "EMA business hours over All Saints' Day and All Souls' Day, 1 and 2 November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-all-saints-day-and-all-souls-day-1-and-2-november-0" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023", "press_release": "No", "related_medicine_referral": "Pseudoephedrine-containing medicinal products;Hydroxyprogesterone caproate-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "27/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-23-26-october-2023" }, { "title": "EMA takes further steps to address critical shortages of medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "", "first_published_date": "24/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-takes-further-steps-address-critical-shortages-medicines-eu" }, { "title": "EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens", "press_release": "No", "related_medicine_referral": "Ozempic", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-alerts-eu-patients-healthcare-professionals-reports-falsified-ozempic-pens" }, { "title": "New treatment option for heavily pre-treated multiple myeloma patients", "press_release": "No", "related_medicine_referral": "Elrexfio", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "13/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-option-heavily-pre-treated-multiple-myeloma-patients" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2023", "press_release": "No", "related_medicine_referral": "Agamree;Elrexfio;Elucirem;Vueway;Loargys;Rezzayo;Veoza;Brukinsa;Imfinzi;Jemperli;Keytruda;Praluent;Prevymis;Rubraca;Veyvondi;Jivadco;Sugammadex Lorien;RoActemra;Translarna;Blenrep;Albrioza;Ocaliva", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "13/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-9-12-october-2023" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 September 2023", "press_release": "No", "related_medicine_referral": "Evanovo;Gumbohatch;Felpreva;Nexgard Spectra;Nobivac DP Plus;Porcilis PCV M Hyo;ProZinc;Simparica;Stelfonta;Zenalpha;Clynav;Felisecto Plus;Innovax-ND-ILT;Leucofeligen FeLV/RCP;Previcox;Stronghold Plus;Oxmax;Loxitab;Poulvac Procerta HVT-IBD;Prevexxion RN+HVT", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "08/09/2023", "last_updated_date": "12/10/2023", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-5-7-september-2023" }, { "title": "Monitoring of products originating from Japan for the possibility of radioactivity", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/05/2011", "last_updated_date": "11/10/2023", "news_url": "https://www.ema.europa.eu/en/news/monitoring-products-originating-japan-possibility-radioactivity" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 October 2023", "press_release": "No", "related_medicine_referral": "Evanovo;Gumbohatch;Felpreva;Nexgard Spectra;Nobivac DP Plus;Porcilis PCV M Hyo;ProZinc;Simparica;Senvelgo;Bovilis Cryptium;Suiseng Diff/A;CircoMax;CircoMax Myco;Clomicalm;Fortekor Plus;Porcilis ColiClos;Porcilis PCV;Porcilis PCV;Porcilis PCV M Hyo;Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli);Suvaxyn CSF Marker;Tulinovet", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "06/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-3-5-october-2023" }, { "title": "EMA Management Board: highlights of October 2023 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2023-meeting" }, { "title": "Revised transparency rules for the EU Clinical Trials Information System (CTIS)", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/10/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/revised-transparency-rules-eu-clinical-trials-information-system-ctis" }, { "title": "EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna", "press_release": "No", "related_medicine_referral": "Translarna", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/09/2023", "last_updated_date": "05/10/2023", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023", "press_release": "No", "related_medicine_referral": "Pseudoephedrine-containing medicinal products;Hydroxyprogesterone caproate-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "29/09/2023", "last_updated_date": "29/09/2023", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-september-2023" }, { "title": "EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep", "press_release": "No", "related_medicine_referral": "Blenrep", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/09/2023", "last_updated_date": "28/09/2023", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-non-renewal-authorisation-multiple-myeloma-medicine-blenrep" }, { "title": "Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/09/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/towards-permanent-collaboration-framework-ema-and-health-technology-assessment-bodies" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023", "press_release": "No", "related_medicine_referral": "Ebglyss;Finlee;Vanflyta;Yorvipath;Zilbrysq;Zoonotic Influenza Vaccine Seqirus;Herwenda;Catiolanze;Adcetris;Enhertu;Kaftrio;Kalydeco;Keytruda;Nordimet;Olumiant;Pepaxti;Ryeqo;Takhzyro;Voxzogo;Lutholaz;Vivjoa;Iclusig;Mysimba;Spikevax (previously COVID-19 Vaccine Moderna);Skycovion;Translarna;Blenrep", "categories": "Human", "topics": "COVID-19;Medicines;Referrals", "news_summary": "", "first_published_date": "15/09/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-september-2023" }, { "title": "Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "14/09/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/spikevax-ema-recommends-approval-adapted-covid-19-vaccine-targeting-omicron-xbb15" }, { "title": "PRAC recommends new measures to avoid topiramate exposure in pregnancy", "press_release": "No", "related_medicine_referral": "Topiramate", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "01/09/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-new-measures-avoid-topiramate-exposure-pregnancy" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023", "press_release": "No", "related_medicine_referral": "Topiramate;Pseudoephedrine-containing medicinal products;Hydroxyprogesterone caproate-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "01/09/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-31-august-2023" }, { "title": "Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "30/08/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/comirnaty-ema-recommends-approval-adapted-covid-19-vaccine-targeting-omicron-xbb15" }, { "title": "EMA review of data on paternal exposure to valproate", "press_release": "Yes", "related_medicine_referral": "Valproate and related substances", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/08/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-review-data-paternal-exposure-valproate" }, { "title": "EMA mourns passing of Noël Wathion", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/08/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-mourns-passing-noel-wathion" }, { "title": "EMA business hours over Assumption Day, 15 August", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19;Mpox", "news_summary": "", "first_published_date": "11/08/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-assumption-day-15-august-0" }, { "title": "Paving the way towards coordinated clinical trials in public health emergencies in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "25/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/paving-way-towards-coordinated-clinical-trials-public-health-emergencies-eu" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2023", "press_release": "No", "related_medicine_referral": "Abrysvo;Apretude;Degarelix Accord;Enrylaze;Inaqovi;Litfulo;Lyfnua;Talvey;Tepkinly;Tevimbra;Tyenne;Tyruko;Yesafili;Orserdu;Krazati;Bylvay;Ervebo;Evrysdi;Keytruda;Olumiant;Opdivo;Spikevax (previously COVID-19 Vaccine Moderna);Gefzuris;Gazyvaro;Synapse;Jesduvroq", "categories": "Human", "topics": "COVID-19;Medicines;Referrals", "news_summary": "", "first_published_date": "21/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-july-2023" }, { "title": "First RSV vaccine to protect infants up to 6 months of age and older adults", "press_release": "No", "related_medicine_referral": "Abrysvo", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "21/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-rsv-vaccine-protect-infants-6-months-age-and-older-adults" }, { "title": "OPEN framework extended to a wider range of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/open-framework-extended-wider-range-medicines" }, { "title": "Reflection paper on the use of artificial intelligence in the lifecycle of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Data on medicines", "news_summary": "", "first_published_date": "19/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/reflection-paper-use-artificial-intelligence-lifecycle-medicines" }, { "title": "European Health Union: EU steps up action to prevent shortages of antibiotics for next winter", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "", "first_published_date": "17/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-health-union-eu-steps-action-prevent-shortages-antibiotics-next-winter" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023", "press_release": "No", "related_medicine_referral": "Yurvac RHD;Tessie;NexGard Combo;Cimalgex;Apoquel;CircoMax;Enteroporc Coli AC;Felpreva;Kexxtone;Tulaven;Dexdomitor;Palladia;Panacur AquaSol;Porcilis PCV;RenuTend;Ypozane;Zactran;Zuprevo", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "14/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-11-13-july-2023" }, { "title": "EMA statement on ongoing review of GLP-1 receptor agonists", "press_release": "No", "related_medicine_referral": "Ozempic;Rybelsus;Saxenda;Xultophy;Bydureon;Byetta;Trulicity;Lyxumia;Suliqua", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "11/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-statement-ongoing-review-glp-1-receptor-agonists" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3 - 6 July 2023", "press_release": "No", "related_medicine_referral": "Topiramate;Pseudoephedrine-containing medicinal products;Hydroxyprogesterone caproate-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "07/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-july-2023" }, { "title": "Phasing out of extraordinary COVID-19 regulatory flexibilities", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "06/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/phasing-out-extraordinary-covid-19-regulatory-flexibilities" }, { "title": "Global regulators confirm good safety profile of COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "05/07/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-confirm-good-safety-profile-covid-19-vaccines" }, { "title": "Use of real-world evidence in regulatory decision making – EMA publishes review of its studies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "23/06/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/use-real-world-evidence-regulatory-decision-making-ema-publishes-review-its-studies" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023", "press_release": "No", "related_medicine_referral": "Aquipta;Jesduvroq;Albrioza;Imjudo;Jardiance;Lonsurf;Refixia;Ryeqo;Soliris;Trodelvy;Dyrupeg;Zefylti;Comirnaty", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/06/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-june-2023" }, { "title": "ACT EU: creating a better environment for clinical trials through collaboration", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "22/06/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/act-eu-creating-better-environment-clinical-trials-through-collaboration" }, { "title": "Report: How EU ensured safety of medicines during COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "22/06/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/report-how-eu-ensured-safety-medicines-during-covid-19" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 June 2023", "press_release": "No", "related_medicine_referral": "Eryseng Parvo;Galliprant;Mhyosphere PCV ID;Simparica Trio;Cytopoint;Easotic;Equilis Prequenza;Equilis Prequenza Te;Nobilis IB 4-91;Prevexxion RN;SevoFlo;Versican Plus DHPPi;Versican Plus DHPPi/L4;Equilis Te", "categories": "Veterinary", "topics": "Maximum residue limit;Medicines", "news_summary": "", "first_published_date": "16/06/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-13-15-june-2023" }, { "title": "EMA Management Board: highlights of June 2023 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/06/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2023-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 - 8 June 2023", "press_release": "No", "related_medicine_referral": "Topiramate;Pseudoephedrine-containing medicinal products;Hydroxyprogesterone caproate-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "09/06/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-june-2023" }, { "title": "EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "06/06/2023", "last_updated_date": "07/06/2023", "news_url": "https://www.ema.europa.eu/en/news/ema-and-ecdc-statement-updating-covid-19-vaccines-target-new-sars-cov-2-virus-variants" }, { "title": "Progress with EU-US mutual recognition agreement for inspections for veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "31/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/progress-eu-us-mutual-recognition-agreement-inspections-veterinary-medicines" }, { "title": "Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "30/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-agree-way-forward-adapt-covid-19-vaccines-emerging-variants" }, { "title": "EMA business hours over Whit Monday, 29 May", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "26/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-whit-monday-29-may" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 May 2023", "press_release": "No", "related_medicine_referral": "Pylclari;Ztalmy;Sogroya;Opdivo;Sohonos;Asimtufii;Susvimo;Adakveo;Adakveo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-may-2023" }, { "title": "Revocation of authorisation for sickle cell disease medicine Adakveo", "press_release": "No", "related_medicine_referral": "Adakveo", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "26/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/revocation-authorisation-sickle-cell-disease-medicine-adakveo" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023", "press_release": "No", "related_medicine_referral": "Arexvy;Camzyos;Columvi;Lytgobi;Opfolda;Sugammadex Piramal;Orkambi;Adempas;Bimzelx;Cosentyx;Opdivo;Revestive;Ronapreve;Spikevax (previously COVID-19 Vaccine Moderna);Vemlidy;Yervoy;Lumevoq;Tidhesco;Epidyolex", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "26/04/2023", "last_updated_date": "26/05/2023", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-26-april-2023" }, { "title": "Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects", "press_release": "No", "related_medicine_referral": "Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "12/05/2023", "last_updated_date": "22/05/2023", "news_url": "https://www.ema.europa.eu/en/news/fluoroquinolone-antibiotics-reminder-measures-reduce-risk-long-lasting-disabling-potentially-irreversible-side-effects" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023", "press_release": "No", "related_medicine_referral": "Topiramate;Pseudoephedrine-containing medicinal products;Hydroxyprogesterone caproate-containing medicinal products;Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "12/05/2023", "last_updated_date": "22/05/2023", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-12-may-2023" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023", "press_release": "No", "related_medicine_referral": "Eluracat;Chanaxin;Hiprabovis IBR Marker Live;Forceris;Librela;Prevexxion RN+HVT+IBD;Purevax RCP FeLV;Purevax RCPCh FeLV;Purevax RC;Purevax RCP;Purevax RCPCh;Reconcile;Strangvac;Versican Plus DHPPi/L4R;Versican Plus Pi/L4R;Ypozane;Canigen L4;MiPet Easecto;Naxcel;Nobivac DP Plus;Nobivac L4;Porcilis ColiClos;Simparica;Vaxxitek HVT+IBD", "categories": "Veterinary", "topics": "Maximum residue limit;Medicines", "news_summary": "", "first_published_date": "22/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-15-16-may-2023" }, { "title": "Guidance for industry to prevent and mitigate medicine shortages", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "", "first_published_date": "17/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/guidance-industry-prevent-mitigate-medicine-shortages" }, { "title": "EMA business hours over Ascension Day holidays, 18 and 19 May", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "16/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-ascension-day-holidays-18-and-19-may" }, { "title": "EMA annual report 2022 published", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "15/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-annual-report-2022-published" }, { "title": "EMA and European medicines regulatory network lift COVID-19 business continuity status", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "10/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-european-medicines-regulatory-network-lift-covid-19-business-continuity-status" }, { "title": "Statement from Emer Cooke on the end of the COVID-19 public health emergency", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "08/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/statement-emer-cooke-end-covid-19-public-health-emergency" }, { "title": "EMA business hours on Europe Day, Tuesday 9 May", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "05/05/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-europe-day-tuesday-9-may" }, { "title": "Review of transparency rules for the EU Clinical Trials Information System (CTIS)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "03/05/2023", "last_updated_date": "03/05/2023", "news_url": "https://www.ema.europa.eu/en/news/review-transparency-rules-eu-clinical-trials-information-system-ctis" }, { "title": "First vaccine to protect older adults from respiratory syncytial virus (RSV) infection", "press_release": "No", "related_medicine_referral": "Arexvy", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "26/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-vaccine-protect-older-adults-respiratory-syncytial-virus-rsv-infection" }, { "title": "EMA business hours over King's Day and Labour Day, 27 April and 1 May", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "25/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-kings-day-and-labour-day-27-april-and-1-may" }, { "title": "European Immunization Week 2023: Statement by Executive Director Emer Cooke - Routine vaccination matters! Every dose counts to stay protected", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "24/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-immunization-week-2023-statement-executive-director-emer-cooke-routine-vaccination-matters-every-dose-counts-stay-protected" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023", "press_release": "No", "related_medicine_referral": "Gumbohatch;Vaxxitek HVT+IBD;Prevexxion RN+HVT+IBD;Prevexxion RN;Melovem;Purevax RCPCh;Purevax RCPCh FeLV;Purevax RCP FeLV;Purevax RCP;Cerenia;Contacera;Onsior;Proteq West Nile", "categories": "Veterinary", "topics": "Maximum residue limit;Medicines", "news_summary": "", "first_published_date": "21/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-18-20-april-2023" }, { "title": "Single-arm trials as pivotal evidence for the authorisation of medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "21/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/single-arm-trials-pivotal-evidence-authorisation-medicines-eu" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023", "press_release": "No", "related_medicine_referral": "Topiramate;Pseudoephedrine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "14/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-april-2023" }, { "title": "Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines", "press_release": "No", "related_medicine_referral": "Veterinary medicinal products containing N-methyl pyrrolidone as an excipient;Vectra 3D;Melovem", "categories": "Veterinary", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "14/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/reducing-risks-human-animal-health-exposure-n-methyl-pyrrolidone-veterinary-medicines" }, { "title": "New features further strengthen Priority Medicines scheme (PRIME)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Research and development", "news_summary": "", "first_published_date": "04/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-features-further-strengthen-priority-medicines-scheme-prime" }, { "title": "EMA business hours over Easter holiday", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/04/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-easter-holiday-0" }, { "title": "EU recommendations for 2023-2024 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "03/04/2023", "last_updated_date": "04/04/2023", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2023-2024-seasonal-flu-vaccine-composition" }, { "title": "Regulatory information – adjusted fees for applications to EMA from 1 April 2023", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/03/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2023" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023", "press_release": "No", "related_medicine_referral": "Bimervax;Briumvi;Omvoh;Pedmarqsi;Epysqli;Qaialdo;Dabigatran Etexilate Accord;Lacosamide Adroiq;Sugammadex Adroiq;Breyanzi;Entresto;Neparvis;Tenkasi (previously Orbactiv);Ultomiris;Wegovy;Feraheme;Raltegravir Viatris", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "31/03/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-march-2023" }, { "title": "EMA recommends approval of Bimervax as a COVID-19 booster vaccine", "press_release": "No", "related_medicine_referral": "Bimervax", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "30/03/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-bimervax-covid-19-booster-vaccine" }, { "title": "DARWIN EU® has completed its first studies and is calling for new data partners", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "28/03/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/darwin-eur-has-completed-its-first-studies-and-calling-new-data-partners" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023", "press_release": "No", "related_medicine_referral": "Bravecto;Kriptazen;Leucofeligen FeLV/RCP;Masivet;NexGard Combo;Prevomax;Suprelorin;Bravecto;Innovax-ILT;Nobilis Influenza H5N2;Porcilis PCV M Hyo;Poulvac E. coli;Purevax Rabies;Stronghold;Versican Plus L4;Versican Plus Pi;Versican Plus Pi/L4;Galliprant;Newflend ND H9", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "24/03/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-21-22-march-2023" }, { "title": "Advancing regulatory science in the EU – mid-point report published", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Innovation;Research and development", "news_summary": "", "first_published_date": "22/03/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/advancing-regulatory-science-eu-mid-point-report-published" }, { "title": "EMA Management Board: highlights of March 2023 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/03/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2023-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "17/03/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-march-2023" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022", "press_release": "No", "related_medicine_referral": "Porcilis PCV ID;Simparica Trio;Credelio Plus;NexGard;Nexgard Spectra;Prevomax;Locatim (previously Serinucoli);Solensia;Purevax RC;Purevax RCP FeLV;Purevax RCPCh FeLV;BTVPUR;Eurican Herpes 205;Purevax RCPCh;Purevax RCP;Suvaxyn CSF Marker;Fevaxyn Pentofel;Suvaxyn PRRS MLV;Mirataz;Imoxat;Panacur AquaSol;Procox;Bluevac BTV (previously Bluevac BTV8);Brucellin Aquilon;Veterinary medicinal products containing N-methyl pyrrolidone as an excipient", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "09/12/2022", "last_updated_date": "15/03/2023", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-6-8-december-2022" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 February 2023", "press_release": "No", "related_medicine_referral": "Bravecto Plus;Zeleris;Aservo EquiHaler;Simparica Trio;Librela;Innovax-ND-IBD;Evanovo;Gumbohatch;Zolvix;BTVPUR;Galliprant;Trocoxil;Procox;Mhyosphere PCV ID;Syvazul BTV;Librela;Halocur;Equip WNV (previously Duvaxyn WNV);Purevax RCP FeLV;Suvaxyn PRRS MLV;Naxcel;Suprelorin;Versican Plus Pi/L4R;Versican Plus Pi/L4;Versican Plus DHPPi/L4;Versican Plus DHPPi/L4R;Versican Plus L4;Vectormune FP ILT;Vectormune FP ILT + AE;Suvaxyn PRRS MLV;AdTab (previously Lotilaner Elanco);Bovilis Nasalgen-C;Coxevac;Innovax-ILT-IBD;Eurican L4;Prolevare", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2023", "last_updated_date": "10/03/2023", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-14-16-february-2023" }, { "title": "EMA pilots scientific advice for certain high-risk medical devices", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medical devices", "news_summary": "", "first_published_date": "27/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-pilots-scientific-advice-certain-high-risk-medical-devices" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 - 23 February 2023", "press_release": "No", "related_medicine_referral": "Vafseo;Hyftor;Akeega;Tidhesco;Tibsovo;Libtayo;Buvidal;Bekemv;Rinvoq;Elfabrio;Esbriet;Opzelura;TachoSil;Lagevrio", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "24/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-february-2023" }, { "title": "Human medicines: highlights of 2022", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2022" }, { "title": "Veterinary medicines: highlights of 2022", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2022" }, { "title": "PRAC starts safety review of pseudoephedrine-containing medicines", "press_release": "No", "related_medicine_referral": "Pseudoephedrine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "10/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prac-starts-safety-review-pseudoephedrine-containing-medicines" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023", "press_release": "No", "related_medicine_referral": "Topiramate;Pseudoephedrine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "10/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-february-2023" }, { "title": "EMA update on shortages of antibiotics in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages;Medicines", "news_summary": "", "first_published_date": "26/01/2023", "last_updated_date": "06/02/2023", "news_url": "https://www.ema.europa.eu/en/news/ema-update-shortages-antibiotics-eu" }, { "title": "Actions to support the development of medicines for children", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Innovation;Medicines;Paediatrics", "news_summary": "", "first_published_date": "06/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/actions-support-development-medicines-children" }, { "title": "Public consultation on a multi-stakeholder platform to improve clinical trials in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "03/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-multi-stakeholder-platform-improve-clinical-trials-eu" }, { "title": "EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Herbal", "topics": "Corporate", "news_summary": "", "first_published_date": "03/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-committee-herbal-medicinal-products-re-elects-emiel-van-galen-chair" }, { "title": "A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medical devices", "news_summary": "", "first_published_date": "02/02/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-role-ema-monitoring-mitigating-critical-medical-device-shortages-during-public-health-emergencies" }, { "title": "Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "31/01/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/use-clinical-trials-information-system-becomes-mandatory-new-clinical-trial-applications-eu" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023", "press_release": "No", "related_medicine_referral": "Sotyktu;Dapagliflozin Viatris;Sitagliptin / Metformin hydrochloride Sun;Tolvaptan Accord;Sohonos;Dupixent;Nubeqa;Reblozyl;Rinvoq;Trecondi;Trulicity;Wakix;Garsun;Imbruvica;Janus kinase inhibitors (JAKi);Adakveo;Paxlovid", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "27/01/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-january-2023" }, { "title": "EMA Committee for Advanced Therapies elects Ilona Reischl as its new Chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/01/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-committee-advanced-therapies-elects-ilona-reischl-its-new-chair" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023", "press_release": "No", "related_medicine_referral": "Suvaxyn Circo+MH RTU;Galliprant;Bovela;Advocate;Nobivac Myxo-RHD Plus;Purevax RC", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "20/01/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-17-18-january-2023" }, { "title": "Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/01/2023", "last_updated_date": "20/01/2023", "news_url": "https://www.ema.europa.eu/en/news/joint-statement-executive-steering-group-shortages-safety-medicinal-products-mssg-shortages-antibiotic-medicines" }, { "title": "Assessment of human dietary exposure to residues of veterinary medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/01/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/assessment-human-dietary-exposure-residues-veterinary-medicines-eu" }, { "title": "Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "19/01/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/mandatory-use-ctis-31-january-2023-all-new-clinical-trial-applications" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023", "press_release": "No", "related_medicine_referral": "Topiramate;Janus kinase inhibitors (JAKi)", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "13/01/2023", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-january-2023" }, { "title": "EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders", "press_release": "No", "related_medicine_referral": "Janus kinase inhibitors (JAKi)", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "11/11/2022", "last_updated_date": "13/01/2023", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-measures-minimise-risk-serious-side-effects-janus-kinase-inhibitors-chronic-inflammatory-disorders" }, { "title": "End-of-year message from EMA’s Executive Director", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Corporate", "news_summary": "", "first_published_date": "21/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/end-year-message-emas-executive-director-0" }, { "title": "EMA business hours over holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "20/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-holiday-period" }, { "title": "Facilitating Decentralised Clinical Trials in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "19/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/facilitating-decentralised-clinical-trials-eu" }, { "title": "EMA Management Board: highlights of December 2022 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2022-meeting" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022", "press_release": "No", "related_medicine_referral": "Hemgenix;Imjudo;Pombiliti;Tremelimumab AstraZeneca;Dimethyl fumarate Accord;Omblastys;Adcirca (previously Tadalafil Lilly);Dupixent;Edistride;Enhertu;Forxiga;Fintepla;Hemlibra;Imfinzi;Kerendia;Spikevax (previously COVID-19 Vaccine Moderna);Triumeq;Imbarkyd;Olumiant;Rambis and associated names;Gelisia and associated names", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "16/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-december-2022" }, { "title": "First gene therapy to treat haemophilia B", "press_release": "No", "related_medicine_referral": "Hemgenix", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-gene-therapy-treat-haemophilia-b" }, { "title": "ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2", "press_release": "No", "related_medicine_referral": "Evusheld;Ronapreve;Xevudy;Regkirona;Paxlovid;Veklury", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "09/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/etf-warns-monoclonal-antibodies-may-not-be-effective-against-emerging-strains-sars-cov-2" }, { "title": "ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "08/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ecdc-and-ema-collaborate-vaccine-safety-and-effectiveness-monitoring-studies" }, { "title": "ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "06/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/etf-concludes-bivalent-original-omicron-ba4-5-mrna-vaccines-may-be-used-primary-vaccination" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022", "press_release": "No", "related_medicine_referral": "Topiramate;Pholcodine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "02/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-november-1-december-2022" }, { "title": "EMA recommends withdrawal of pholcodine medicines from EU market", "press_release": "No", "related_medicine_referral": "Pholcodine-containing medicinal products", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "02/12/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-withdrawal-pholcodine-medicines-eu-market" }, { "title": "DARWIN EU® welcomes first data partners", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "23/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/darwin-eur-welcomes-first-data-partners" }, { "title": "New Quality Innovation Expert Group (QIG) supports medicine innovation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Quality of medicines", "news_summary": "", "first_published_date": "21/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-quality-innovation-expert-group-qig-supports-medicine-innovation" }, { "title": "Best practices to fight antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "21/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/best-practices-fight-antimicrobial-resistance" }, { "title": "European Antibiotic Awareness Day 2022: Preventing antimicrobial resistance together", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "18/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-2022-preventing-antimicrobial-resistance-together" }, { "title": "Sales of antibiotics for animal use have almost halved between 2011-2021", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "18/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/sales-antibiotics-animal-use-have-almost-halved-between-2011-2021" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022", "press_release": "No", "related_medicine_referral": "Neoleish;Rabitec;Versican Plus Pi/L4R;Versican Plus DHPPi/L4R;ProteqFlu;ProteqFlu-Te;Apoquel;Aservo EquiHaler;Semintra;Lydaxx;Simparica Trio;Rhiniseng;Porcilis PCV M Hyo;Librela;Onsior;Convenia;Solensia;Equilis Prequenza;Equilis Prequenza Te;Nobivac DP Plus", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "11/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-8-10-november-2022" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022", "press_release": "No", "related_medicine_referral": "Janus kinase inhibitors (JAKi);VidPrevtyn Beta;Kauliv;Pirfenidone Viatris;Sugammadex Amomed;Ceprotin;Comirnaty;DuoPlavin;Dupixent;Enhertu;Eylea;Imfinzi;Iscover;Lynparza;Plavix;Xofluza;Orepaxam;Febseltiq;Gavreto;Ilaris", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "11/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-7-10-november-2022" }, { "title": "New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome", "press_release": "No", "related_medicine_referral": "Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "11/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-recommendations-terlipressin-containing-medicines-treatment-hepatorenal-syndrome-0" }, { "title": "EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines", "press_release": "No", "related_medicine_referral": "Amfepramone-containing medicinal products", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "11/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-recommendation-withdraw-marketing-authorisations-amfepramone-medicines-0" }, { "title": "EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine", "press_release": "No", "related_medicine_referral": "VidPrevtyn Beta", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "10/11/2022", "last_updated_date": "11/11/2022", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-vidprevtyn-beta-covid-19-booster-vaccine" }, { "title": "Regulatory update - EMA encourages companies to submit type I variations for 2022 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/11/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2022-end-november" }, { "title": "EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders", "press_release": "No", "related_medicine_referral": "Janus kinase inhibitors (JAKi);Xeljanz;Cibinqo;Olumiant;Rinvoq;Jyseleca", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "28/10/2022", "last_updated_date": "03/11/2022", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-measures-minimise-risk-serious-side-effects-janus-kinase-inhibitors-chronic-inflammatory-disorders" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 October 2022", "press_release": "No", "related_medicine_referral": "Janus kinase inhibitors (JAKi);Amfepramone-containing medicinal products;Stelara;Spikevax (previously COVID-19 Vaccine Moderna);Comirnaty", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "28/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-october-2022" }, { "title": "EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines", "press_release": "No", "related_medicine_referral": "Amfepramone-containing medicinal products", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "28/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-recommendation-withdraw-marketing-authorisations-amfepramone-medicines" }, { "title": "EMA business hours over All Saints' Day and All Souls' Day, 1 and 2 November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "28/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-all-saints-day-and-all-souls-day-1-and-2-november" }, { "title": "EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "19/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-comirnaty-spikevax-covid-19-vaccines-children-6-months-age" }, { "title": "EMA recommends approval of second adapted Spikevax vaccine", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "19/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-second-adapted-spikevax-vaccine" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022", "press_release": "No", "related_medicine_referral": "Ebvallo;Eladynos;Livmarli;Locametz;Qdenga;Pluvicto;Spevigo;Dimethyl fumarate Teva;Pemetrexed Baxter;Plerixafor Accord;Brukinsa;Libtayo;Lyumjev (previously Liumjev);Xydalba;Tuznue;Hervelous;Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Medicines;Medicines for use outside the EU", "news_summary": "", "first_published_date": "14/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-october-2022" }, { "title": "First therapy to treat transplant patients with post-transplant lymphoproliferative disease", "press_release": "No", "related_medicine_referral": "Ebvallo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "14/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-therapy-treat-transplant-patients-post-transplant-lymphoproliferative-disease" }, { "title": "New vaccine to protect people in the EU and worldwide against dengue", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Medicines for use outside the EU", "news_summary": "", "first_published_date": "14/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-vaccine-protect-people-eu-and-worldwide-against-dengue" }, { "title": "High-quality data to empower data-driven medicines regulation in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "10/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/high-quality-data-empower-data-driven-medicines-regulation-european-union" }, { "title": "EMA Management Board: highlights of October 2022 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2022-meeting" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022", "press_release": "No", "related_medicine_referral": "Meloxoral;Mometamax Ultra;Simparica;MiPet Easecto;Equip WNV (previously Duvaxyn WNV);CircoMax;CircoMax Myco;Arti-Cell Forte;Zenalpha;Bovela;Versican Plus Pi/L4R;Versican Plus DHPPi/L4R", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "07/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-4-6-october-2022" }, { "title": "Chair of the European Network of Paediatric Research at EMA re-elected", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "05/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/chair-european-network-paediatric-research-ema-re-elected" }, { "title": "Call for expression of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "05/10/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/call-expression-interest-civil-society-representatives-participate-work-emas-paediatric-committee" }, { "title": "Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-pharmacovigilance-applications-3-october-2022" }, { "title": "New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome", "press_release": "No", "related_medicine_referral": "Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "30/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-recommendations-terlipressin-containing-medicines-treatment-hepatorenal-syndrome" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022", "press_release": "No", "related_medicine_referral": "Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome;Janus kinase inhibitors (JAKi);Amfepramone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "30/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-september-2022" }, { "title": "EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Medicines", "news_summary": "", "first_published_date": "29/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-pilot-offers-enhanced-support-academic-and-non-profit-developers-advanced-therapy-medicinal-products" }, { "title": "New co-chairs elected for working parties for healthcare professionals and for patients and consumers", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-co-chairs-elected-working-parties-healthcare-professionals-and-patients-and-consumers" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022", "press_release": "No", "related_medicine_referral": "Beyfortus;Enjaymo;Livtencity;Melatonin Neurim;Mycapssa;Pyrukynd;Zynlonta;Sorafenib Accord;Teriflunomide Accord;Teriflunomide Viatris (previously Teriflunomide Mylan);Teriparatide Sun;Ximluci;Adtralza;Biktarvy;Brukinsa;Evusheld;Exparel liposomal;Revolade;Skyrizi;Vaxneuvance;Veklury;Xalkori;Yescarta;Exkivity;Synchron", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "16/09/2022", "last_updated_date": "22/09/2022", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-september-2022" }, { "title": "Biosimilar medicines can be interchanged", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Biosimilars", "news_summary": "", "first_published_date": "19/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged" }, { "title": "New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection", "press_release": "No", "related_medicine_referral": "Beyfortus", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-protect-babies-and-infants-respiratory-syncytial-virus-rsv-infection" }, { "title": "EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "16/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-standard-marketing-authorisations-comirnaty-spikevax-covid-19-vaccines" }, { "title": "Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "12/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/adapted-vaccine-targeting-ba4-ba5-omicron-variants-original-sars-cov-2-recommended-approval" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022", "press_release": "No", "related_medicine_referral": "Exzolt;Porcilis PCV ID;Solensia;Improvac;Clynav;Evicto;Poulvac E. coli;Tulinovet;Vaxxitek HVT+IBD;Prevexxion RN+HVT+IBD;Prevexxion RN;Improvac", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "09/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-6-8-september-2022" }, { "title": "ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "06/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ecdc-ema-statement-booster-vaccination-omicron-adapted-bivalent-covid-19-vaccines" }, { "title": "Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "30/08/2022", "last_updated_date": "02/09/2022", "news_url": "https://www.ema.europa.eu/en/news/accelerating-clinical-trials-eu-publication-2022-2026-workplan" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022", "press_release": "No", "related_medicine_referral": "Nomegestrol and chlormadinone;Janus kinase inhibitors (JAKi);Topiramate;Pholcodine-containing medicinal products;Amfepramone-containing medicinal products;Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "02/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-august-1-september-2022" }, { "title": "Review of pholcodine medicines started", "press_release": "No", "related_medicine_referral": "Pholcodine-containing medicinal products", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "02/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/review-pholcodine-medicines-started" }, { "title": "PRAC starts review of topiramate use in pregnancy and women of childbearing potential", "press_release": "No", "related_medicine_referral": "Topiramate", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "02/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prac-starts-review-topiramate-use-pregnancy-and-women-childbearing-potential" }, { "title": "New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone", "press_release": "No", "related_medicine_referral": "Nomegestrol and chlormadinone;Zoely", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "02/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-measures-minimise-risk-meningioma-medicines-containing-nomegestrol-or-chlormadinone" }, { "title": "First adapted COVID-19 booster vaccines recommended for approval in the EU", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "01/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-adapted-covid-19-booster-vaccines-recommended-approval-eu" }, { "title": "Have your say on EMA’s communications – how are we doing?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/09/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/have-your-say-emas-communications-how-are-we-doing-0" }, { "title": "EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox ", "press_release": "No", "related_medicine_referral": "Imvanex", "categories": "Human", "topics": "Mpox;Vaccines", "news_summary": "", "first_published_date": "19/08/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emas-emergency-task-force-advises-intradermal-use-imvanex-jynneos-against-monkeypox" }, { "title": "EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "18/08/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-conditional-marketing-authorisation-application-skycovion-covid-19-vaccine" }, { "title": "EMA business hours over Assumption Day, 15 August", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "11/08/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-assumption-day-15-august" }, { "title": "Big data use for public health: publication of Big Data Steering Group workplan 2022-25", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Research and development", "news_summary": "", "first_published_date": "28/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/big-data-use-public-health-publication-big-data-steering-group-workplan-2022-25" }, { "title": "EMA reviewing data on sabizabulin for COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "27/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-reviewing-data-sabizabulin-covid-19" }, { "title": "EMA response to the monkeypox public health emergency", "press_release": "No", "related_medicine_referral": "Tecovirimat SIGA;Imvanex", "categories": "Human", "topics": "Mpox;Medicines", "news_summary": "", "first_published_date": "27/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-response-monkeypox-public-health-emergency" }, { "title": "Hydroxyethyl-starch solutions for infusion recommended for suspension from the market", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "25/02/2022", "last_updated_date": "26/07/2022", "news_url": "https://www.ema.europa.eu/en/news/hydroxyethyl-starch-solutions-infusion-recommended-suspension-market" }, { "title": "EMA Paediatric Committee elects Brian Aylward as its new Chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-paediatric-committee-elects-brian-aylward-its-new-chair" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022", "press_release": "No", "related_medicine_referral": "Amvuttra;Celdoxome pegylated liposomal;Lupkynis;Mounjaro;Nulibry;Opdualag;Tecvayli;Tezspire;Vabysmo;Thalidomide Lipomed;Parsaclisib Incyte Biosciences Distribution B.V.;Genvoya;Imcivree;Imvanex;Retsevmo;Tecartus;Ultomiris;Imcivree;Rubraca;Lutetium (177Lu) chloride Billev (previously Illuzyce)", "categories": "Human", "topics": "COVID-19;Mpox;Medicines", "news_summary": "", "first_published_date": "22/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-july-2022" }, { "title": "New medicine for multiple myeloma patients with limited treatment options", "press_release": "No", "related_medicine_referral": "Tecvayli", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-multiple-myeloma-patients-limited-treatment-options" }, { "title": "EMA recommends restricting use of cancer medicine Rubraca", "press_release": "No", "related_medicine_referral": "Rubraca;Rubraca", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "22/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-restricting-use-cancer-medicine-rubraca" }, { "title": "EMA recommends approval of Imvanex for the prevention of monkeypox disease", "press_release": "No", "related_medicine_referral": "Imvanex", "categories": "Human", "topics": "Mpox;Medicines", "news_summary": "", "first_published_date": "22/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-imvanex-prevention-monkeypox-disease" }, { "title": "Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-call-international-collaboration-integrate-real-world-evidence-regulatory-decision-making" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022", "press_release": "No", "related_medicine_referral": "AdTab (previously Lotilaner Elanco);Purevax RCPCh;Purevax RCPCh FeLV;Letifend;NexGard;Prevomax;ProZinc;Hiprabovis IBR Marker Live", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "15/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-12-14-july-2022" }, { "title": "Towards better prevention of medicine shortages in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages", "news_summary": "", "first_published_date": "15/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/towards-better-prevention-medicine-shortages-eu" }, { "title": "EMA re-elected as chair of ICMRA from October 2022", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "13/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-re-elected-chair-icmra-october-2022" }, { "title": "EMA launches pilot project on analysis of raw data from clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "12/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-launches-pilot-project-analysis-raw-data-clinical-trials" }, { "title": "ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ecdc-and-ema-update-recommendations-additional-booster-doses-mrna-covid-19-vaccines" }, { "title": "Further measures to identify and address medicine shortages during public health emergencies adopted", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "08/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/further-measures-identify-address-medicine-shortages-during-public-health-emergencies-adopted" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022", "press_release": "No", "related_medicine_referral": "Nomegestrol and chlormadinone;Zoely;Janus kinase inhibitors (JAKi)", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "08/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-july-2022" }, { "title": "Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma", "press_release": "No", "related_medicine_referral": "Nomegestrol and chlormadinone;Zoely", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "08/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/medicines-containing-nomegestrol-or-chlormadinone-prac-recommends-new-measures-minimise-risk-meningioma" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022", "press_release": "No", "related_medicine_referral": "Breyanzi;Paxlovid;Sondelbay;Stimufend;Dasatinib Accord;Dasatinib Accordpharma;Vildagliptin / Metformin hydrochloride Accord;Ipique;Abylqis;Aliqopa;Tookad;Brilique;Ayvakyt;Briviact (in Italy: Nubriveo);Dupixent;Jardiance;Lacosamide UCB;Senshio;Tecfidera;Vimpat;Etifoxine-containing medicinal products;Synchron;Nasolam and associated names;Lidocain/Prilocain Idetec and associated names", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "28/01/2022", "last_updated_date": "05/07/2022", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-january-2022" }, { "title": "Global regulators agree on key principles on adapting vaccines to tackle virus variants", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "01/07/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-agree-key-principles-adapting-vaccines-tackle-virus-variants" }, { "title": "Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "30/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/assessing-dietary-exposure-residues-veterinary-medicines-feed-additives-and-pesticides-food-animal-origin-eu" }, { "title": "Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "28/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/call-companies-register-their-industry-single-point-contact-i-spoc-supply-and-availability" }, { "title": "Monkeypox: EMA starts review for Imvanex", "press_release": "No", "related_medicine_referral": "Imvanex", "categories": "Human", "topics": "Mpox;Vaccines", "news_summary": "", "first_published_date": "28/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/monkeypox-ema-starts-review-imvanex" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022", "press_release": "No", "related_medicine_referral": "COVID-19 Vaccine (inactivated, adjuvanted) Valneva;Pepaxti;Rayvow;Roctavian;Scemblix;Sunlenca;Vyvgart;Vyvgart;Ranivisio;Vegzelma;Tuznue;Hervelous;Crysvita;Enhertu;Imbruvica;Lynparza;Nuvaxovid;Rinvoq;Zerbaxa;Synchron", "categories": "Human", "topics": "COVID-19;Medicines;Referrals", "news_summary": "", "first_published_date": "24/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-june-2022" }, { "title": "First gene therapy to treat severe haemophilia A", "press_release": "No", "related_medicine_referral": "Roctavian", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-gene-therapy-treat-severe-haemophilia" }, { "title": "EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU", "press_release": "No", "related_medicine_referral": "COVID-19 Vaccine (inactivated, adjuvanted) Valneva", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "23/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-valnevas-covid-19-vaccine-authorisation-eu" }, { "title": "EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17", "press_release": "No", "related_medicine_referral": "Nuvaxovid", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "23/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-authorisation-nuvaxovid-adolescents-aged-12-17" }, { "title": "Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "20/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-work-towards-strengthening-collaboration-observational-research-beyond-covid-19-pandemic" }, { "title": "EMA Management Board: highlights of June 2022 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2022-meeting" }, { "title": "Start of rolling review for adapted Spikevax COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "17/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/start-rolling-review-adapted-spikevax-covid-19-vaccine" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 June 2022", "press_release": "No", "related_medicine_referral": "Cortaderm;DogStem;Evanovo;Bravecto;Coxatab;Circovac;Nobilis IB 4-91;Credelio;Onsior;Suprelorin;Loxicom;Felpreva", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "17/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-14-15-june-2022" }, { "title": "Start of rolling review for adapted Comirnaty COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "15/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/start-rolling-review-adapted-comirnaty-covid-19-vaccine" }, { "title": "Big Data strategy for veterinary medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "13/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/big-data-strategy-veterinary-medicines-eu" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022", "press_release": "No", "related_medicine_referral": "Amfepramone-containing medicinal products", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "10/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-june-2022" }, { "title": "EMA recommends withdrawal of marketing authorisation for amfepramone medicines", "press_release": "No", "related_medicine_referral": "Amfepramone-containing medicinal products", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "10/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-withdrawal-marketing-authorisation-amfepramone-medicines" }, { "title": "EMA publishes annual report 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "10/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-publishes-annual-report-2021" }, { "title": "EMA adopts first list of critical medicines for COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "08/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-adopts-first-list-critical-medicines-covid-19" }, { "title": "EMA business hours over Whit Monday holiday, 6 June", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "02/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-whit-monday-holiday-6-june" }, { "title": "EMA appoints Chief Medical Officer", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "", "first_published_date": "01/06/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-appoints-chief-medical-officer" }, { "title": "EMA business hours over Ascension Day holidays, 26 and 27 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "24/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-ascension-day-holidays-26-and-27-may" }, { "title": "EMA guidance supports development of new antibiotics", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Paediatrics", "news_summary": "", "first_published_date": "24/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-guidance-supports-development-new-antibiotics" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022", "press_release": "No", "related_medicine_referral": "Sitoiganap;Xenpozyme;Synchron;Rinvoq;Xeljanz;Kinpeygo;Ertapenem SUN;Nexpovio;HemAryo;Tuznue;Sugammadex Fresenius Kabi;Olumiant;Sitagliptin / Metformin hydrochloride Accord;Zokinvy;Cevenfacta;Upstaza;Cosentyx;Keytruda;Ganirelix Gedeon Richter;Daruph and Anafezyn;Hervelous;Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "20/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-may-2022" }, { "title": "First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes)", "press_release": "No", "related_medicine_referral": "Zokinvy", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-children-progeria-or-progeroid-syndromes-rare-premature-aging-syndromes" }, { "title": "First therapy to treat rare genetic nervous system disorder AADC deficiency", "press_release": "No", "related_medicine_referral": "Upstaza", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-therapy-treat-rare-genetic-nervous-system-disorder-aadc-deficiency" }, { "title": "Synchron Research Service: suspension of medicines over flawed studies", "press_release": "No", "related_medicine_referral": "Synchron", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "20/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/synchron-research-service-suspension-medicines-over-flawed-studies" }, { "title": "First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder", "press_release": "No", "related_medicine_referral": "Xenpozyme", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-therapy-treat-two-types-niemann-pick-disease-rare-genetic-metabolic-disorder" }, { "title": "International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "17/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-and-who-support-healthcare-professionals-enhance-public-confidence-covid-19-vaccines" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May 2022", "press_release": "No", "related_medicine_referral": "Vectormune ND;Sileo;Apoquel;Suprelorin;Innovax-ND-IBD;Zenalpha;Innovax-ND-ILT;Canigen L4;Nobivac L4;Credelio Plus;Fortekor Plus;Cerenia;Nasym;Aservo EquiHaler;Librela", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "13/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-10-12-may-2022" }, { "title": "Gerrit Johan Schefferlie elected new Chair of EMA Committee for Veterinary Medicinal Products (CVMP)", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/gerrit-johan-schefferlie-elected-new-chair-ema-committee-veterinary-medicinal-products-cvmp" }, { "title": "Extended mandate: First meeting of Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/extended-mandate-first-meeting-executive-steering-group-shortages-safety-medicinal-products-mssg" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022", "press_release": "No", "related_medicine_referral": "Defitelio", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "06/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-may-2022" }, { "title": "EMA business hours on Europe Day, Monday 9 May", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "05/05/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-europe-day-monday-9-may" }, { "title": "European Immunization Week 2022: Statement by Executive Director Emer Cooke - Why vaccines contribute to a “Long Life for All”", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "25/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-immunization-week-2022-statement-executive-director-emer-cooke-why-vaccines-contribute-long-life-all" }, { "title": "EMA business hours over King's Day holiday", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "25/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-kings-day-holiday" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022", "press_release": "No", "related_medicine_referral": "Filsuvez;Lunsumio;Tabrecta;Pirfenidone axunio (previously Pirfenidone AET);Tecfidera;Yselty;Aduhelm;Neffy;Miplyffa;Bydureon;Elonva;Keytruda;NovoSeven;Retsevmo;Tecentriq;Yescarta;Actrapid;Insulatard;Rubraca", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-april-2022" }, { "title": "Facilitating global access to diabetes treatments for non-EU patients", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Medicines for use outside the EU", "news_summary": "", "first_published_date": "22/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/facilitating-global-access-diabetes-treatments-non-eu-patients" }, { "title": "EMA starts review of cancer medicine Rubraca", "press_release": "No", "related_medicine_referral": "Rubraca", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "22/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-cancer-medicine-rubraca" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 April 2022", "press_release": "No", "related_medicine_referral": "Bonqat;Nexgard Spectra;Rabitec;Suprelorin", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-11-13-april-2022" }, { "title": "EMA and the EUnetHTA 21 consortium set priorities for their collaboration", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "12/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-and-eunethta-21-consortium-set-priorities-their-collaboration" }, { "title": "EMA business hours over Easter holiday", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "12/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-business-hours-over-easter-holiday" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022", "press_release": "No", "related_medicine_referral": "Janus kinase inhibitors (JAKi);Spikevax (previously COVID-19 Vaccine Moderna);Comirnaty;Amfepramone-containing medicinal products;Nomegestrol and chlormadinone;Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome;Nulojix", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals;Vaccines", "news_summary": "", "first_published_date": "08/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-april-2022" }, { "title": "ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "06/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ecdc-ema-issue-advice-fourth-doses-mrna-covid-19-vaccines" }, { "title": "Regulatory information – 0.3% and 5.3% increase in general fees from 1 April 2022", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Fees", "news_summary": "", "first_published_date": "01/04/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-03-and-53-increase-general-fees-1-april-2022" }, { "title": "EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "31/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-establishes-cancer-medicines-forum-academia-optimise-cancer-treatments-clinical-practice" }, { "title": "Advice to sponsors on managing the impact of the war in Ukraine on clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Clinical trials", "news_summary": "", "first_published_date": "30/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/advice-sponsors-managing-impact-war-ukraine-clinical-trials" }, { "title": "EU recommendations for 2022-2023 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "29/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2022-2023-seasonal-flu-vaccine-composition" }, { "title": "EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "29/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-hipra-phh-1v" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022", "press_release": "No", "related_medicine_referral": "Carvykti;Evusheld;Camcevi;Amifampridine SERB;Cabometyx;Jakavi;Keytruda;Kymriah;Polivy;Vyxeos liposomal (previously Vyxeos);Dimherity", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "25/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-march-2022" }, { "title": "New gene therapy to treat adult patients with multiple myeloma", "press_release": "No", "related_medicine_referral": "Carvykti", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-gene-therapy-treat-adult-patients-multiple-myeloma" }, { "title": "EMA recommends authorisation of COVID-19 medicine Evusheld", "press_release": "No", "related_medicine_referral": "Evusheld", "categories": "Human", "topics": "COVID-19;Data on medicines", "news_summary": "", "first_published_date": "24/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-authorisation-covid-19-medicine-evusheld" }, { "title": "EMA Management Board: highlights of March 2022 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2022-meeting" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 March 2022", "press_release": "No", "related_medicine_referral": "Coliprotec F4/F18;Advocate;BTVPUR;Cepedex;Inflacam;Rheumocam;Porcilis ColiClos;ProteqFlu-Te;Recocam", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "18/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-15-16-march-2022" }, { "title": "EMA Management Board elects Lorraine Nolan as chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "17/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-elects-lorraine-nolan-chair" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022", "press_release": "No", "related_medicine_referral": "Janus kinase inhibitors (JAKi);Spikevax (previously COVID-19 Vaccine Moderna);Jcovden (previously COVID-19 Vaccine Janssen);Amfepramone-containing medicinal products;Nomegestrol and chlormadinone;Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals;Vaccines", "news_summary": "", "first_published_date": "11/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-march-2022" }, { "title": "PRIME enables earlier availability of life-changing medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Early access", "news_summary": "", "first_published_date": "03/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prime-enables-earlier-availability-life-changing-medicines" }, { "title": "Regulation on EMA’s extended mandate becomes applicable", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Governance;Medicine shortages;Scientific advice;Vaccines", "news_summary": "", "first_published_date": "01/03/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulation-emas-extended-mandate-becomes-applicable" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022", "press_release": "No", "related_medicine_referral": "PreHevbri;Kapruvia;Kimmtrak;Orgovyx;Quviviq;Vydura;Inpremzia;Truvelog Mix 30;Amversio;Dimethyl fumarate Neuraxpharm;Dimethyl fumarate Polpharma;Dimethyl fumarate Mylan;Sitagliptin Accord;Aduhelm;Padcev;Tecfidera;Ipique;Opdivo;Spikevax (previously COVID-19 Vaccine Moderna);Verzenios;Delstrigo;Pifeltro;Beovu;Yervoy", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "25/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-february-2022" }, { "title": "New medicine for rare type of eye cancer", "press_release": "No", "related_medicine_referral": "Kimmtrak", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-rare-type-eye-cancer" }, { "title": "EMA recommends authorisation of booster doses of Comirnaty from 12 years of age", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "24/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-authorisation-booster-doses-comirnaty-12-years-age" }, { "title": "EMA recommends approval of Spikevax for children aged 6 to 11", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "24/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-spikevax-children-aged-6-11" }, { "title": "European medicines regulatory network adopts EU common standard for electronic product information", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Product information", "news_summary": "", "first_published_date": "22/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-regulatory-network-adopts-eu-common-standard-electronic-product-information" }, { "title": "Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 February 2022", "press_release": "No", "related_medicine_referral": "Chanaxin;RenuTend;Forceris;Strangvac;Tulissin;Veraflox;Purevax RCPCh FeLV;Purevax RCP FeLV;Purevax RCP;Purevax RC;Purevax RCPCh;Arti-Cell Forte;Comfortis;Daxocox;ProteqFlu;ProteqFlu-Te;Simparica Trio;Neptra;Nobivac Myxo-RHD Plus", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "21/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-15-16-february-2022" }, { "title": "Veterinary medicines: highlights of 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2021" }, { "title": "Human medicines: highlights of 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2021" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022", "press_release": "No", "related_medicine_referral": "Janus kinase inhibitors (JAKi);Xeljanz;Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna);Cibinqo;Jyseleca;Rinvoq;Olumiant", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals;Vaccines", "news_summary": "", "first_published_date": "11/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-february-2022" }, { "title": "PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "11/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-suspending-hydroxyethyl-starch-solutions-infusion-market-0" }, { "title": "EMA starts safety review of Janus kinase inhibitors for inflammatory disorders", "press_release": "No", "related_medicine_referral": "Janus kinase inhibitors (JAKi)", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "11/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-safety-review-janus-kinase-inhibitors-inflammatory-disorders" }, { "title": "Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "09/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/initiation-darwin-eur-coordination-centre-advances-integration-real-world-evidence-assessment-medicines-eu" }, { "title": "EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "08/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-evaluating-data-booster-dose-covid-19-vaccine-comirnaty-adolescents" }, { "title": "Public consultation on reflection paper on prophylactic use of antimicrobials in animals", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "08/02/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-reflection-paper-prophylactic-use-antimicrobials-animals" }, { "title": "A stronger role for EMA", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/stronger-role-ema" }, { "title": "New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma", "press_release": "No", "related_medicine_referral": "Breyanzi", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "28/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-gene-therapy-treatment-patients-relapsed-or-refractory-large-b-cell-lymphoma" }, { "title": "COVID-19: EMA recommends conditional marketing authorisation for Paxlovid", "press_release": "No", "related_medicine_referral": "Paxlovid", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "27/01/2022", "last_updated_date": "28/01/2022", "news_url": "https://www.ema.europa.eu/en/news/covid-19-ema-recommends-conditional-marketing-authorisation-paxlovid" }, { "title": "New EU rules for safe and high-quality medicines for animals become effective", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "28/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-eu-rules-safe-and-high-quality-medicines-animals-become-effective" }, { "title": "Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "25/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-harmonisation-clinical-trials-eu-clinical-trials-regulation-enter-application-and-new-clinical-trials-information-system-be-launched" }, { "title": "Increase in manufacturing capacity for Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "24/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increase-manufacturing-capacity-vaxzevria-previously-covid-19-vaccine-astrazeneca" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 2022", "press_release": "No", "related_medicine_referral": "Credelio;VarroMed;Purevax RC;Purevax RCPCh;Purevax RCPCh FeLV;Evant;Cimalgex;Hiprabovis IBR Marker Live;Ingelvac CircoFLEX;Isemid;NexGard;Frontpro (previously Afoxolaner Merial);Solensia;Stronghold Plus;Felisecto Plus;Syvazul BTV;Stelfonta;Suvaxyn Circo", "categories": "Veterinary", "topics": "Maximum residue limit;Medicines", "news_summary": "", "first_published_date": "21/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-18-19-january-2022" }, { "title": "International regulators’ recommendations on COVID-19 vaccines and the Omicron variant", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "21/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-recommendations-covid-19-vaccines-and-omicron-variant" }, { "title": "COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "18/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-latest-safety-data-provide-reassurance-about-use-mrna-vaccines-during-pregnancy" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022", "press_release": "No", "related_medicine_referral": "Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome;Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Jcovden (previously COVID-19 Vaccine Janssen);Mavenclad", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals;Vaccines", "news_summary": "", "first_published_date": "14/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-january-2022" }, { "title": "EMA welcomes EU Commissioner for Health and Food Safety", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "13/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-welcomes-eu-commissioner-health-food-safety" }, { "title": "Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address patients’ needs", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "13/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/accelerating-clinical-trials-eu-act-eu-better-clinical-trials-address-patients-needs" }, { "title": "Global regulators discuss path towards regulatory alignment on response to Omicron variant", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "13/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-discuss-path-towards-regulatory-alignment-response-omicron-variant" }, { "title": "Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/preliminary-data-indicate-covid-19-vaccines-remain-effective-against-severe-disease-hospitalisation-caused-omicron-variant" }, { "title": "EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "10/01/2022", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-paxlovid-pf-07321332-ritonavir-treating-patients-covid-19" }, { "title": "Emer Cooke’s end-of-year message", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "22/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emer-cookes-end-year-message" }, { "title": "EMA recommends Nuvaxovid for authorisation in the EU", "press_release": "No", "related_medicine_referral": "Nuvaxovid", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "20/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu" }, { "title": "EMA working on COVID-19 over holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "20/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-working-covid-19-over-holiday-period-0" }, { "title": "EMA Management Board: highlights of December 2021 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2021-meeting" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021", "press_release": "No", "related_medicine_referral": "Oxbryta;Aduhelm;Lorviqua;Sapropterin Dipharma;Xevudy;Veklury;Keytruda;Padcev;Kineret;Entyvio;Ontilyv;Yselty;Ngenla;Saphnelo;Teysuno;Kerendia;Zektayos - Hepjuvo;Sitagliptin / Metformin hydrochloride Mylan;Okedi;Prevenar 20 (previously Apexxnar)", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "17/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021" }, { "title": "New treatment for sickle cell disease", "press_release": "No", "related_medicine_referral": "Oxbryta", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-sickle-cell-disease" }, { "title": "EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "16/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-issues-advice-use-paxlovid-pf-07321332-ritonavir-treatment-covid-19-rolling-review-starts-parallel" }, { "title": "Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen);Spikevax (previously COVID-19 Vaccine Moderna);Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "16/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increase-manufacturing-capacity-covid-19-vaccines-janssen-moderna-biontech-pfizer" }, { "title": "EMA recommends approval for use of Kineret in adults with COVID-19", "press_release": "No", "related_medicine_referral": "Kineret", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "16/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-use-kineret-adults-covid-19" }, { "title": "COVID-19: EMA recommends authorisation of antibody medicine Xevudy", "press_release": "No", "related_medicine_referral": "Xevudy", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "16/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-antibody-medicine-xevudy" }, { "title": "EMA launches the Regulatory Science Research Needs initiative", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Research and development", "news_summary": "", "first_published_date": "15/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-launches-regulatory-science-research-needs-initiative" }, { "title": "COVID-19 Vaccine Janssen: EMA recommendation on booster dose", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "15/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-ema-recommendation-booster-dose" }, { "title": "EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "14/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-reviewing-new-data-effectiveness-lagevrio-molnupiravir-treatment-covid-19" }, { "title": "International regulators’ reflections on remote approaches to GCP and GMP regulatory oversight during COVID-19 pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "13/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-reflections-remote-approaches-gcp-and-gmp-regulatory-oversight-during-covid-19-pandemic" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 December 2021", "press_release": "No", "related_medicine_referral": "Bravecto;Cytopoint;Meloxidyl;Zeleris;Mhyosphere PCV ID;Neocolipor;Forceris;Simparica;Felisecto Plus;Simparica Trio;MiPet Easecto;Stronghold Plus;Vaxxitek HVT+IBD", "categories": "Veterinary", "topics": "Maximum residue limit;Medicines", "news_summary": "", "first_published_date": "10/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-7-9-december-2021" }, { "title": "International regulators stress continued need for COVID-19 therapeutics", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "10/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-stress-continued-need-covid-19-therapeutics" }, { "title": "EMA and ECDC recommendations on heterologous vaccination courses against COVID-19: ‘mix-and-match’ approach can be used for both initial courses and boosters", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "07/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-ecdc-recommendations-heterologous-vaccination-courses-against-covid-19-mix-match-approach-can-be-used-both-initial-courses-boosters" }, { "title": "ICMRA high-level meeting on global health emergencies and regulatory approaches", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "06/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/icmra-high-level-meeting-global-health-emergencies-and-regulatory-approaches" }, { "title": "EMA recommends approval for use of RoActemra in adults with severe COVID-19", "press_release": "No", "related_medicine_referral": "RoActemra", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "06/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-use-roactemra-adults-severe-covid-19" }, { "title": "ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "03/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/icmra-and-who-map-out-flexibilities-used-regulators-respond-covid-19-pandemic" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021", "press_release": "No", "related_medicine_referral": "Comirnaty;Amfepramone-containing medicinal products;Nomegestrol and chlormadinone;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals;Vaccines", "news_summary": "", "first_published_date": "03/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-november-2-december-2021" }, { "title": "EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)", "press_release": "No", "related_medicine_referral": "COVID-19 Vaccine (inactivated, adjuvanted) Valneva", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "02/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-valnevas-covid-19-vaccine-vla2001" }, { "title": "Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "01/12/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increase-manufacturing-capacity-covid-19-vaccine-astrazeneca" }, { "title": "Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "25/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11" }, { "title": "A vision for use of real-world evidence in EU medicines regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "24/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/vision-use-real-world-evidence-eu-medicines-regulation" }, { "title": "EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "23/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-lagevrio-molnupiravir-treating-patients-covid-19" }, { "title": "2011-2020: More than 40% decrease in sales of antimicrobials for use in animals", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "23/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/2011-2020-more-40-decrease-sales-antimicrobials-use-animals" }, { "title": "EMA evaluating data on booster dose of COVID-19 Vaccine Janssen", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "22/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-evaluating-data-booster-dose-covid-19-vaccine-janssen" }, { "title": "EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "19/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-issues-advice-use-lagevrio-molnupiravir-treatment-covid-19" }, { "title": "EMA starts review of Paxlovid for treating patients with COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "19/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-paxlovid-treating-patients-covid-19" }, { "title": "European Antibiotic Awareness Day: Fighting the silent pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "18/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-fighting-silent-pandemic" }, { "title": "EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "18/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-xevudy-sotrovimab-treating-patients-covid-19" }, { "title": "EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "17/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-novavaxs-covid-19-vaccine-nuvaxovid" }, { "title": "COVID-19: EMA recommends authorisation of two monoclonal antibody medicines", "press_release": "No", "related_medicine_referral": "Regkirona;Ronapreve", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "11/11/2021", "last_updated_date": "12/11/2021", "news_url": "https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021", "press_release": "No", "related_medicine_referral": "Dengvaxia;Epclusa;Kaftrio;Kalydeco;Noxafil;Flynpovi;Cervarix;Nexviadyme;Nouryant;Rapiscan;Skytrofa (previously Lonapegsomatropin Ascendis Pharma);Lumykras;Regkirona;Ronapreve;Riltrava Aerosphere;Tavneos;Tecovirimat SIGA;Uplizna;Voraxaze;Vyepti;Wegovy;Ipique;Lidocain/Prilocain Idetec and associated names", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "12/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-8-11-november-2021" }, { "title": "First-in-class medicine recommended for treatment of rare blood vessel inflammation", "press_release": "No", "related_medicine_referral": "Tavneos", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "12/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-class-medicine-recommended-treatment-rare-blood-vessel-inflammation" }, { "title": "EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "10/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-evaluating-use-covid-19-vaccine-spikevax-children-aged-6-11" }, { "title": "COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "08/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-ema-and-heads-medicines-agencies-update-molnupiravir" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 2021", "press_release": "No", "related_medicine_referral": "Respiporc FLUpan H1N1;Bovela;Halagon;Credelio;Coliprotec F4;Vaxxitek HVT+IBD;CircoMax", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "08/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-3-4-november-2021" }, { "title": "EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "02/11/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-ends-rolling-review-antibodies-bamlanivimab-and-etesevimab-covid-19-following-withdrawal-lilly" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021", "press_release": "No", "related_medicine_referral": "Imbruvica;Amfepramone-containing medicinal products;Nomegestrol and chlormadinone", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals;Vaccines", "news_summary": "", "first_published_date": "29/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-october-2021" }, { "title": "Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "", "news_summary": "", "first_published_date": "29/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2021-november-2021" }, { "title": "Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Scientific advice", "news_summary": "", "first_published_date": "28/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/repurposing-authorised-medicines-pilot-support-not-profit-organisations-and-academia" }, { "title": "Call for expressions of interest for civil society representatives to participate in work of EMA", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "22/09/2021", "last_updated_date": "27/10/2021", "news_url": "https://www.ema.europa.eu/en/news/call-expressions-interest-civil-society-representatives-participate-work-ema" }, { "title": "EMA working on COVID-19 during closure on 1 and 2 November 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "27/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-working-covid-19-during-closure-1-and-2-november-2021" }, { "title": "Generating high-quality evidence from registry-based studies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Scientific guidelines", "news_summary": "", "first_published_date": "26/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/generating-high-quality-evidence-registry-based-studies" }, { "title": "Spikevax: EMA recommendation on booster", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "25/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/spikevax-ema-recommendation-booster" }, { "title": "COVID-19: EMA starts rolling review of molnupiravir", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "25/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-ema-starts-rolling-review-molnupiravir" }, { "title": "EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Paediatrics;Vaccines", "news_summary": "", "first_published_date": "18/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-evaluating-use-covid-19-vaccine-comirnaty-children-aged-5-11" }, { "title": "New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "18/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-manufacturing-sites-and-new-formulation-approved-covid-19-vaccine-biontech-pfizer" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021", "press_release": "No", "related_medicine_referral": "Cibinqo;Rybrevant;Zynyz;Sitagliptin SUN;Repatha;Aspaveli;Keytruda;Trodelvy;Lenvima;Hizentra;Skyrizi;Zeposia;Xeljanz;Kisplyx;Vaxneuvance;Forxiga;Edistride;Lidocain/Prilocain Idetec and associated names", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "15/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-october-2021" }, { "title": "First-in-class medicine to treat aggressive form of breast cancer", "press_release": "No", "related_medicine_referral": "Trodelvy", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-class-medicine-treat-aggressive-form-breast-cancer" }, { "title": "EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)", "press_release": "No", "related_medicine_referral": "Evusheld", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "14/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-evusheld-tixagevimab-cilgavimab" }, { "title": "EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "12/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-ends-rolling-review-cvncov-covid-19-vaccine-following-withdrawal-curevac-ag" }, { "title": "A global approach to regulatory flexibility to increase manufacturing capacity during COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "12/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-approach-regulatory-flexibility-increase-manufacturing-capacity-during-covid-19" }, { "title": "EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Paediatrics", "news_summary": "", "first_published_date": "11/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-ronapreve-casirivimab-imdevimab-treatment-prevention-covid-19" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 5-7 October 2021", "press_release": "No", "related_medicine_referral": "Imoxat;Zenalpha;Suiseng Diff/A;Apoquel;NexGard Combo;Nobivac L4;Reconcile;Vaxxitek HVT+IBD;Prevexxion RN+HVT+IBD;Prevexxion RN;VarroMed;Stronghold Plus;Bravecto Plus;Ubac;Letifend;Purevax RC;Purevax RCP;Purevax RCP FeLV;Purevax RCPCh;Purevax RCPCh FeLV;Baycox Iron;Bovilis Blue-8;Clevor;Porcilis AR-T DF;Recocam;Respiporc FLUpan H1N1", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "08/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-5-7-october-2021" }, { "title": "Highlights of Management Board – October 2021 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/highlights-management-board-october-2021-meeting" }, { "title": "Additional manufacturing site for COVID-19 Vaccine Janssen", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "07/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/additional-manufacturing-site-covid-19-vaccine-janssen-0" }, { "title": "Comirnaty and Spikevax: EMA recommendations on extra doses and boosters", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "04/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/comirnaty-spikevax-ema-recommendations-extra-doses-boosters" }, { "title": "EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "04/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-regkirona-regdanvimab-treating-patients-covid-19" }, { "title": "EMA welcomes new Head of International Affairs", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Careers;Governance", "news_summary": "", "first_published_date": "01/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-welcomes-new-head-international-affairs" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021", "press_release": "No", "related_medicine_referral": "Nomegestrol and chlormadinone;Zoely;Amfepramone-containing medicinal products;Jcovden (previously COVID-19 Vaccine Janssen);Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Pharmacovigilance", "news_summary": "", "first_published_date": "01/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-september-2021" }, { "title": "EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines", "press_release": "No", "related_medicine_referral": "Nomegestrol and chlormadinone", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "01/10/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-meningioma-risk-nomegestrol-chlormadinone-containing-medicines" }, { "title": "Transatlantic Taskforce continues international fight against antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Antimicrobial resistance;Clinical trials", "news_summary": "", "first_published_date": "30/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/transatlantic-taskforce-continues-international-fight-against-antimicrobial-resistance" }, { "title": "EMA implements new measures to minimise animal testing during medicines development", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Innovation", "news_summary": "", "first_published_date": "29/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-implements-new-measures-minimise-animal-testing-during-medicines-development" }, { "title": "EMA evaluating data on booster dose of COVID-19 vaccine Spikevax", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "27/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-evaluating-data-booster-dose-covid-19-vaccine-spikevax" }, { "title": "Call for expressions of interest for civil society representatives to participate in work of Committee for Advanced Therapies", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/call-expressions-interest-civil-society-representatives-participate-work-committee-advanced-therapies" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021", "press_release": "No", "related_medicine_referral": "Amfepramone-containing medicinal products;Imbruvica;Comirnaty;Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Pharmacovigilance", "news_summary": "", "first_published_date": "03/09/2021", "last_updated_date": "17/09/2021", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-30-august-2-september-2021" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021", "press_release": "No", "related_medicine_referral": "Artesunate Amivas;Brukinsa;Gavreto;Hukyndra;Libmyris;Qinlock;Vumerity;Rivaroxaban Viatris (previously Rivaroxaban Mylan);Sugammadex Mylan;Nouryant;Nexviadyme;Raylumis;Adempas;Firmagon;Jyseleca;Keytruda;Noxafil;Nucala;Opdivo;Segluromet;Steglatro;Zepatier;Oportuzumab monatox DLRC Pharma Services;Livmarli;Teriparatide Cinnagen;Sildenafil FGK;Byannli (previously Paliperidone Janssen-Cilag International)", "categories": "Human", "topics": "COVID-19;Medicines;Referrals", "news_summary": "", "first_published_date": "17/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-september-2021" }, { "title": "New add-on treatment for rare autoimmune inflammatory disorder", "press_release": "No", "related_medicine_referral": "Nucala", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-add-treatment-rare-autoimmune-inflammatory-disorder" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 September 2021", "press_release": "No", "related_medicine_referral": "Frontpro (previously Afoxolaner Merial);Porcilis PCV ID;Poulvac E. coli;Circovac;Innovax-ND-IBD;Innovax-ND-IBD;Innovax-ILT;Locatim (previously Serinucoli);Prevomax;ProZinc;Startvac;Felpreva;Vepured", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "10/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-7-9-september-2021" }, { "title": "Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "09/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increase-manufacturing-capacity-covid-19-vaccine-biontech-pfizer" }, { "title": "EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "06/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-evaluating-data-booster-dose-covid-19-vaccine-comirnaty" }, { "title": "ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "02/09/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ecdc-ema-highlight-considerations-additional-booster-doses-covid-19-vaccines" }, { "title": "Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna);Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "24/08/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increase-vaccine-manufacturing-capacity-covid-19-vaccines-biontech-pfizer-and-moderna" }, { "title": "EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19", "press_release": "No", "related_medicine_referral": "RoActemra", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "16/08/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-evaluating-use-roactemra-hospitalised-adults-severe-covid-19" }, { "title": "Artificial intelligence in medicine regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Innovation;Medicines", "news_summary": "", "first_published_date": "16/08/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/artificial-intelligence-medicine-regulation" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen);Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Amfepramone-containing medicinal products", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "06/08/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-august-2021" }, { "title": "Interoperability of track and trace systems: key to public health protection", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "06/08/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/interoperability-track-trace-systems-key-public-health-protection" }, { "title": "ECDC and EMA update on COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "04/08/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ecdc-ema-update-covid-19" }, { "title": "Six-month countdown to go-live for the Clinical Trials Information System (CTIS)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "02/08/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/six-month-countdown-go-live-clinical-trials-information-system-ctis" }, { "title": "Increased manufacturing capacity and supply for Spikevax", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "30/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increased-manufacturing-capacity-supply-spikevax" }, { "title": "COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "23/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-spikevax-approved-children-aged-12-17-eu" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021", "press_release": "No", "related_medicine_referral": "Deltyba;Siklos;Ultomiris;Volibris;Zeposia;Zynteglo;Tecentriq;Flynpovi;Nexviadyme;Imatinib Koanaa;Nouryant;Vosevi", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "23/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-july-2021" }, { "title": "CHMP endorses review finding no link between viral vector in Zynteglo and blood cancer", "press_release": "No", "related_medicine_referral": "Zynteglo;Zynteglo", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "23/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/chmp-endorses-review-finding-no-link-between-viral-vector-zynteglo-blood-cancer" }, { "title": "COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "22/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-guillain-barre-syndrome-listed-very-rare-side-effect" }, { "title": "The European Medicines Agency mourns the passing of Jordi Llinares Garcia", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "", "first_published_date": "21/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-mourns-passing-jordi-llinares-garcia" }, { "title": "EMA starts rolling review of COVID-19 vaccine Vidprevtyn", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "20/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-vidprevtyn" }, { "title": "EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure", "press_release": "No", "related_medicine_referral": "Kineret", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "19/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-evaluating-use-kineret-adult-covid-19-patients-increased-risk-severe-respiratory-failure" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 July 2021", "press_release": "No", "related_medicine_referral": "Ingelvac CircoFLEX;Suvaxyn CSF Marker;Apoquel;Ecoporc Shiga;Librela;Locatim (previously Serinucoli);Nobilis Influenza H5N2;Porcilis PCV;Stelfonta;Vectormune ND;Halagon;Advocate;Kriptazen;Vectra 3D;Acticam;Bravecto Plus;Chanhold;Evant;Innovax-ND-IBD;Suvaxyn PRRS MLV;Vepured", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "16/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-13-15-july-2021" }, { "title": "International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "16/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-work-towards-alignment-development-authorisation-second-generation-covid-19-vaccines" }, { "title": "EMA and ECDC update on COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "14/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-ecdc-update-covid-19" }, { "title": "Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "09/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/comirnaty-spikevax-possible-link-very-rare-cases-myocarditis-pericarditis" }, { "title": "EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "09/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-advises-against-use-covid-19-vaccine-janssen-people-history-capillary-leak-syndrome" }, { "title": "EMA finds no evidence linking viral vector in Zynteglo to blood cancer", "press_release": "No", "related_medicine_referral": "Zynteglo;Zynteglo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "09/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-finds-no-evidence-linking-viral-vector-zynteglo-blood-cancer" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna);Jcovden (previously COVID-19 Vaccine Janssen);Zynteglo;Zynteglo", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "09/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-july-2021" }, { "title": "Increased manufacturing capacity for COVID-19 Vaccine Janssen", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "02/07/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increased-manufacturing-capacity-covid-19-vaccine-janssen" }, { "title": "Deputy Executive Director Noël Wathion retires after 25 years of service", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "", "first_published_date": "30/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/deputy-executive-director-noel-wathion-retires-after-25-years-service" }, { "title": "Use of antibiotics in animals is decreasing", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "30/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/use-antibiotics-animals-decreasing" }, { "title": "Update of EU recommendations for 2021–2022 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "28/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-eu-recommendations-2021-2022-seasonal-flu-vaccine-composition" }, { "title": "Success rate for marketing authorisation applications from SMEs doubles between 2016 and 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "SME", "news_summary": "", "first_published_date": "28/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/success-rate-marketing-authorisation-applications-smes-doubles-between-2016-2020" }, { "title": "Additional manufacturing site for COVID-19 Vaccine Janssen", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "25/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/additional-manufacturing-site-covid-19-vaccine-janssen" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021", "press_release": "No", "related_medicine_referral": "Edistride;Forxiga;Galafold;Opdivo;Rinvoq;Xeljanz;Abiraterone Mylan;Fingolimod Mylan;Flynpovi;Abecma;Bimzelx;Byooviz;Evrenzo;Minjuvi;Voxzogo;Esbriet;Etifoxine-containing medicinal products", "categories": "Human", "topics": "COVID-19;Medicines;Referrals", "news_summary": "", "first_published_date": "25/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-june-2021" }, { "title": "First cell-based gene therapy to treat adult patients with multiple myeloma", "press_release": "No", "related_medicine_referral": "Abecma", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-cell-based-gene-therapy-treat-adult-patients-multiple-myeloma" }, { "title": "New treatment for people with dwarfism", "press_release": "No", "related_medicine_referral": "Voxzogo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-people-dwarfism" }, { "title": "Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "22/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/two-additional-manufacturing-sites-biontech-pfizers-covid-19-vaccine" }, { "title": "Highlights of Management Board: June 2021 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19;Fees;Governance", "news_summary": "", "first_published_date": "18/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/highlights-management-board-june-2021-meeting" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021", "press_release": "No", "related_medicine_referral": "Tessie;Fatrovax RHD;Strangvac;Baycox Iron;Eryseng;Eryseng Parvo;Locatim (previously Serinucoli);Porcilis ColiClos;BTVPUR;Eravac;Sedadex", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "18/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-15-17-june-2021" }, { "title": "IT systems temporarily unavailable from 18 to 20 June 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/it-systems-temporarily-unavailable-18-20-june-2021" }, { "title": "Annual report 2020 published", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "14/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/annual-report-2020-published" }, { "title": "COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-authorities-eu-take-steps-safeguard-vaccine-quality" }, { "title": "Additional manufacturing capacity for Moderna’s COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/additional-manufacturing-capacity-modernas-covid-19-vaccine" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021", "press_release": "No", "related_medicine_referral": "Zynteglo;Amfepramone-containing medicinal products;Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "11/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-june-2021" }, { "title": "COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis", "press_release": "No", "related_medicine_referral": "Comirnaty;Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Spikevax (previously COVID-19 Vaccine Moderna);Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccines-update-ongoing-evaluation-myocarditis-pericarditis" }, { "title": "Vaxzevria: EMA advises against use in people with history of capillary leak syndrome", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/vaxzevria-ema-advises-against-use-people-history-capillary-leak-syndrome" }, { "title": "International regulators and WHO address need to boost COVID-19 vaccine confidence", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-who-address-need-boost-covid-19-vaccine-confidence" }, { "title": "EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "08/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-evaluating-use-covid-19-vaccine-moderna-young-people-aged-12-17" }, { "title": "EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "07/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-raises-awareness-clinical-care-recommendations-manage-suspected-thrombosis-thrombocytopenia-syndrome" }, { "title": "Advancing international collaboration on COVID-19 real-world evidence and observational studies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "04/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/advancing-international-collaboration-covid-19-real-world-evidence-observational-studies" }, { "title": "EU regulators develop recommendations to forecast demand of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "03/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-regulators-develop-recommendations-forecast-demand-medicines" }, { "title": "Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "01/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/additional-manufacturing-capacity-biontech-pfizers-covid-19-vaccine" }, { "title": "EMA and EUnetHTA take stock of their cooperation", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "01/06/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-and-eunethta-take-stock-their-cooperation" }, { "title": "First COVID-19 vaccine approved for children aged 12 to 15 in EU", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "28/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-covid-19-vaccine-approved-children-aged-12-15-eu" }, { "title": "Insufficient data on use of inhaled corticosteroids to treat COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "27/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/insufficient-data-use-inhaled-corticosteroids-treat-covid-19" }, { "title": "Medical Device Regulation comes into application", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medical devices", "news_summary": "", "first_published_date": "26/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application" }, { "title": "EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "21/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-issues-advice-use-sotrovimab-vir-7831-treating-covid-19" }, { "title": "Vaxzevria: further advice on blood clots and low blood platelets", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "21/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/vaxzevria-further-advice-blood-clots-low-blood-platelets" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021", "press_release": "No", "related_medicine_referral": "Bylvay;Imcivree;Ozawade;Ryeqo;Skysona;Verquvo;Icatibant Accord;Blincyto;Eucreas;Galvus;Icandra (previously Vildagliptin / metformin hydrochloride Novartis);Jalra;Xiliarx;Opdivo;Spherox;Yervoy;Zomarist;Skysona;Klisyri;Jardiance;Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Tecentriq;Darzalex;Libtayo;Evotaz", "categories": "Human", "topics": "COVID-19;Medicines;Referrals", "news_summary": "", "first_published_date": "21/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-may-2021" }, { "title": "First treatment for rare liver disease", "press_release": "No", "related_medicine_referral": "Bylvay", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-rare-liver-disease" }, { "title": "New treatment for obesity caused by rare genetic disorders", "press_release": "No", "related_medicine_referral": "Imcivree", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-obesity-caused-rare-genetic-disorders" }, { "title": "First gene therapy to treat children with rare inherited neurological disease", "press_release": "No", "related_medicine_referral": "Skysona", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-gene-therapy-treat-children-rare-inherited-neurological-disease" }, { "title": "EMA reminds physicians to use Tecentriq with nab-paclitaxel for treating breast cancer", "press_release": "No", "related_medicine_referral": "Tecentriq", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "01/10/2020", "last_updated_date": "21/05/2021", "news_url": "https://www.ema.europa.eu/en/news/ema-reminds-physicians-use-tecentriq-nab-paclitaxel-treating-breast-cancer" }, { "title": "EMA working on COVID-19 during closure on 24 May 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "20/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-working-covid-19-during-closure-24-may-2021" }, { "title": "More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "17/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/more-flexible-storage-conditions-biontech-pfizers-covid-19-vaccine" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 2021", "press_release": "No", "related_medicine_referral": "Simparica Trio;Vectra 3D;Vectra Felis;Cytopoint;Draxxin;Osurnia;Circovac;Clynav;Mirataz;Panacur AquaSol;Posatex;Spironolactone Ceva;Bonqat", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "17/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-10-12-may-2021" }, { "title": "Additional measures to allow experts to focus on COVID-19 activities", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Governance", "news_summary": "", "first_published_date": "11/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/additional-measures-allow-experts-focus-covid-19-activities" }, { "title": "EMA working on COVID-19 during closure on 13 and 14 May 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "11/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-working-covid-19-during-closure-13-14-may-2021" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021", "press_release": "No", "related_medicine_referral": "Comirnaty;Jcovden (previously COVID-19 Vaccine Janssen);Spikevax (previously COVID-19 Vaccine Moderna);Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Zynteglo;Amfepramone-containing medicinal products", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "07/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-may-2021" }, { "title": "EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "07/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-sotrovimab-vir-7831-covid-19" }, { "title": "International regulators and WHO call for wider public access to clinical data", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials;Medicines", "news_summary": "", "first_published_date": "07/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-who-call-wider-public-access-clinical-data" }, { "title": "Confidentiality arrangement between EU and Brazilian regulatory authorities", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "06/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/confidentiality-arrangement-between-eu-brazilian-regulatory-authorities" }, { "title": "Becoming a member of one of EMA’s scientific advisory groups", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "05/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/becoming-member-one-emas-scientific-advisory-groups" }, { "title": "EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "04/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-vero-cell-inactivated" }, { "title": "EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "03/05/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-evaluating-use-covid-19-vaccine-comirnaty-young-people-aged-12-15" }, { "title": "EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen", "press_release": "No", "related_medicine_referral": "Olumiant", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "29/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-evaluating-use-olumiant-hospitalised-covid-19-patients-requiring-supplemental-oxygen" }, { "title": "EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-ecdc-join-forces-enhanced-post-marketing-monitoring-covid-19-vaccines-europe" }, { "title": "AstraZeneca’s COVID-19 vaccine: benefits and risks in context", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "23/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-benefits-and-risks-context" }, { "title": "Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna", "press_release": "No", "related_medicine_referral": "Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "23/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increase-vaccine-manufacturing-capacity-supply-covid-19-vaccines-biontech-pfizer-moderna" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021", "press_release": "No", "related_medicine_referral": "Aubagio;BiResp Spiromax;DuoResp Spiromax;Maviret;Nulojix;Tagrisso;Venclyxto;Opdivo;Yervoy", "categories": "Human", "topics": "Generic and hybrid medicines;Medicines;Referrals", "news_summary": "", "first_published_date": "23/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-april-2021" }, { "title": "New treatment for rare autoimmune disease of nerve cells", "press_release": "No", "related_medicine_referral": "Enspryng", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-rare-autoimmune-disease-nerve-cells" }, { "title": "EMA working on COVID-19 during closure on 27 April 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "23/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-working-covid-19-during-closure-27-april-2021" }, { "title": "Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "21/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/clinical-trials-information-system-reaches-major-milestone-towards-go-live-and-application-clinical-trial-regulation" }, { "title": "COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "20/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood-platelets" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021", "press_release": "No", "related_medicine_referral": "Comfortis;Purevax Rabies;Purevax RCP FeLV;Purevax RCPCh;Purevax RCP;Purevax RCPCh FeLV;Versican Plus Pi/L4R;Versican Plus DHPPi/L4R;Versican Plus Pi/L4;Versican Plus Pi/L4R;Versican Plus L4;Versican Plus DHPPi/L4R;Versican Plus DHPPi/L4;Galliprant;Kexxtone;Simparica Trio;Baycox Iron;Evalon;Gumbohatch;Oncept IL-2;Palladia;SevoFlo;Suvaxyn Circo+MH RTU;Zeleris", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "16/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-13-15-april-2021" }, { "title": "EMA starts review of VIR-7831 for treating patients with COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "15/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-vir-7831-treating-patients-covid-19" }, { "title": "AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "14/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-provide-further-context-risk-very-rare-blood-clots-low-blood-platelets" }, { "title": "COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "14/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-assessment-very-rare-cases-unusual-blood-clots-low-platelets-continues" }, { "title": "IT systems intermittently unavailable from 16 to 18 April 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/it-systems-intermittently-unavailable-16-18-april-2021" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Jcovden (previously COVID-19 Vaccine Janssen);Zynteglo;Amfepramone-containing medicinal products", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "09/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-april-2021" }, { "title": "AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "07/04/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood-platelets" }, { "title": "AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "31/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/astrazeneca-covid-19-vaccine-review-very-rare-cases-unusual-blood-clots-continues" }, { "title": "EU recommendations for 2021-2022 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "30/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2021-2022-seasonal-flu-vaccine-composition" }, { "title": "EMA working on COVID-19 over holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "30/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-working-covid-19-over-holiday-period" }, { "title": "Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Comirnaty;Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "26/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increase-vaccine-manufacturing-capacity-supply-covid-19-vaccines-astrazeneca-biontech-pfizer-moderna" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021", "press_release": "No", "related_medicine_referral": "Benlysta;Kalydeco;Kaftrio;Ponvory;Copiktra;Drovelis;Lydisilka;Efmody;Saxenda;Tecentriq;Xtandi;Brilique", "categories": "Human", "topics": "COVID-19;Generic and hybrid medicines;Medicines;Referrals", "news_summary": "", "first_published_date": "26/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-march-2021" }, { "title": "EMA issues advice on use of regdanvimab for treating COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "26/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-issues-advice-use-regdanvimab-treating-covid-19" }, { "title": "COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "25/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-update-ongoing-evaluation-blood-clot-cases" }, { "title": "EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "22/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-advises-against-use-ivermectin-prevention-or-treatment-covid-19-outside-randomised-clinical-trials" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-18 March 2021", "press_release": "No", "related_medicine_referral": "Cortavance;Ingelvac CircoFLEX;Suvaxyn Circo+MH RTU;Suvaxyn Circo;Aivlosin;MS-H Vaccine", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-16-18-march-2021" }, { "title": "COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "18/03/2021", "last_updated_date": "19/03/2021", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots-low-blood-platelets" }, { "title": "Investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events continues", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "16/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/investigation-covid-19-vaccine-astrazeneca-thromboembolic-events-continues" }, { "title": "EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "15/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emas-safety-committee-continues-investigation-covid-19-vaccine-astrazeneca-thromboembolic-events-further-update" }, { "title": "EMA Management Board – highlights of March 2021 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2021-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021", "press_release": "No", "related_medicine_referral": "Ifosfamide solutions;Zynteglo;Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Spikevax (previously COVID-19 Vaccine Moderna);Comirnaty;Xeljanz;Eylea", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "12/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-march-2021" }, { "title": "Benefits of ifosfamide solutions continue to outweigh risks EMA’s safety committee (PRAC) has concluded that the benefits of ifosfamide solutions for infusion", "press_release": "No", "related_medicine_referral": "Ifosfamide solutions", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "12/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/benefits-ifosfamide-solutions-continue-outweigh-risks-emas-safety-committee-prac-has-concluded-benefits-ifosfamide-solutions-infusion" }, { "title": "COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events - vaccine’s benefits currently still outweigh risks - Update", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits-currently-still-outweigh-risks-update" }, { "title": "EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "11/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-janssen-authorisation-eu" }, { "title": "EMA website briefly unavailable on 15 March 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-15-march-2021" }, { "title": "EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesevimab for COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "11/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-eli-lilly-antibodies-bamlanivimab-etesevimab-covid-19" }, { "title": "COVID-19 Vaccine AstraZeneca: PRAC preliminary view suggests no specific issue with batch used in Austria", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "10/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-preliminary-view-suggests-no-specific-issue-batch-used-austria" }, { "title": "EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)", "press_release": "No", "related_medicine_referral": "Bamlanivimab and etesevimab for COVID-19", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "05/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-issues-advice-use-antibody-combination-bamlanivimab-etesevimab" }, { "title": "EMA website briefly unavailable on 8 March 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-8-march-2021" }, { "title": "EMA starts rolling review of the Sputnik V COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "04/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-sputnik-v-covid-19-vaccine" }, { "title": "EMA review of regdanvimab for COVID-19 to support national decisions on early use", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "02/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-review-regdanvimab-covid-19-support-national-decisions-early-use" }, { "title": "EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "02/03/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-health-canada-publish-clinical-data-used-support-their-authorisations-moderna-covid-19-vaccine" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2021", "press_release": "No", "related_medicine_referral": "Evrysdi;Jemperli;Orladeyo;Abevmy;Lextemy;Abiraterone Accord;Cabometyx;Opdivo;Sarclisa;Epidyolex;Quofenix;Trelegy Ellipta;Varilrix;Elebrato Ellipta;Temybric Ellipta", "categories": "Human", "topics": "COVID-19;Biosimilars;Generic and hybrid medicines;Medicines;Referrals", "news_summary": "", "first_published_date": "26/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-february-2021" }, { "title": "EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "26/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-issues-advice-use-regn-cov2-antibody-combination-casirivimab-imdevimab" }, { "title": "First oral treatment for spinal muscular atrophy (SMA) recommended for approval", "press_release": "No", "related_medicine_referral": "Evrysdi", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-oral-treatment-spinal-muscular-atrophy-sma-recommended-approval" }, { "title": "Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Regulatory and procedural guidance;Vaccines", "news_summary": "", "first_published_date": "25/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/adapting-covid-19-vaccines-sars-cov-2-variants-guidance-vaccine-manufacturers" }, { "title": "International cooperation to align approaches for regulation of COVID-19 vaccines and medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "25/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-cooperation-align-approaches-regulation-covid-19-vaccines-medicines" }, { "title": "EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "24/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-celltrion-antibody-regdanvimab-covid-19" }, { "title": "EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen", "press_release": "No", "related_medicine_referral": "Veklury", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "23/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-evaluating-use-veklury-covid-19-patients-not-requiring-supplemental-oxygen" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 2021", "press_release": "No", "related_medicine_referral": "Emdocam;Equioxx;Aivlosin;ProteqFlu-Te;Suvaxyn CSF Marker;Vectormune ND;Zactran;Eurican Herpes 205;Sevohale (previously Sevocalm);Stronghold Plus;Felisecto Plus;Aivlosin;Coliprotec F4/F18;Hydrocortisone aceponate Ecuphar (previously Cortacare);Fortekor Plus;Leucofeligen FeLV/RCP;Pexion;Credelio Plus;Daxocox;Ultifend ND IBD", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-16-17-february-2021" }, { "title": "Precautionary marketing suspension of thalassaemia medicine Zynteglo", "press_release": "No", "related_medicine_referral": "Zynteglo", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/precautionary-marketing-suspension-thalassaemia-medicine-zynteglo" }, { "title": "EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "16/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021", "press_release": "No", "related_medicine_referral": "Amfepramone-containing medicinal products;Ifosfamide solutions;Zolgensma;Venclyxto;Strimvelis;Veklury", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "12/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-february-2021" }, { "title": "EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "12/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-curevacs-covid-19-vaccine-cvncov" }, { "title": "EMA preparing guidance to tackle COVID-19 variants", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "10/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-preparing-guidance-tackle-covid-19-variants" }, { "title": "Clarification on Sputnik V vaccine in the EU approval process", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "10/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process" }, { "title": "International regulators working together to enhance collaboration on COVID-19 observational research", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "08/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-working-together-enhance-collaboration-covid-19-observational-research" }, { "title": "EMA reviewing data on monoclonal antibody use for COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "04/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-reviewing-data-monoclonal-antibody-use-covid-19" }, { "title": "EMA COVID-19 assessments ‘OPEN’ to non-EU regulators", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "04/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-covid-19-assessments-open-non-eu-regulators" }, { "title": "EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "03/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-novavaxs-covid-19-vaccine-nvx-cov2373" }, { "title": "EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "01/02/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-regn-cov2-antibody-combination-casirivimab-imdevimab" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021", "press_release": "No", "related_medicine_referral": "Sirturo;Vaxchora;Tysabri;Dexamethasone Taw;Tecentriq;BroPair Spiromax;Byfavo;Vaxzevria (previously COVID-19 Vaccine AstraZeneca);Kesimpta;Nexpovio;Ontozry;Pemazyre;Seffalair Spiromax;Sogroya;Vazkepa;Alymsys;Oyavas;Thiotepa Riemser;Keytruda", "categories": "Human", "topics": "Biosimilars;Generic and hybrid medicines;Medicines", "news_summary": "", "first_published_date": "29/01/2021", "last_updated_date": "01/02/2021", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-29-january-2021" }, { "title": "EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "29/01/2021", "last_updated_date": "29/01/2021", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu" }, { "title": "First COVID-19 vaccine safety update published", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "29/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-covid-19-vaccine-safety-update-published" }, { "title": "Clarification of Comirnaty dosage interval", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "28/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/clarification-comirnaty-dosage-interval" }, { "title": "Cyberattack on EMA - update 6", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/cyberattack-ema-update-6" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021", "press_release": "No", "related_medicine_referral": "Exzolt;Cytopoint;Eravac;Gumbohatch;Melosus;Meloxoral;Nobilis IB Primo QX;Nobilis IB 4-91;VarroMed;Evant;Pirsue;Respiporc Flu3;Semintra;Stelfonta;Suvaxyn Circo;Suvaxyn PCV;VarroMed", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "22/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-19-20-january-2021" }, { "title": "Human medicines: highlights of 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2020" }, { "title": "Veterinary medicines: highlights of 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "21/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2020" }, { "title": "Extra dose from vials of Comirnaty COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "08/01/2021", "last_updated_date": "20/01/2021", "news_url": "https://www.ema.europa.eu/en/news/extra-dose-vials-comirnaty-covid-19-vaccine" }, { "title": "Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "COVID-19", "news_summary": "", "first_published_date": "19/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-highlight-key-role-healthcare-professionals-fostering-confidence-covid-19-vaccines" }, { "title": "Cyberattack on EMA - update 5", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/01/2021", "last_updated_date": "15/01/2021", "news_url": "https://www.ema.europa.eu/en/news/cyberattack-ema-update-5" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021", "press_release": "No", "related_medicine_referral": "Comirnaty;Alkindi", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "15/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-january-2021" }, { "title": "Cyberattack on EMA - update 4", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/cyberattack-ema-update-4" }, { "title": "EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "12/01/2021", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-astrazeneca" }, { "title": "EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "06/01/2021", "last_updated_date": "06/01/2021", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-moderna-authorisation-eu" }, { "title": "Update on rolling review of AstraZeneca’s COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "30/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-rolling-review-astrazenecas-covid-19-vaccine" }, { "title": "IT systems temporarily unavailable from 31 December 2020 to 1 January 2021", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/it-systems-temporarily-unavailable-31-december-2020-1-january-2021" }, { "title": "EMA organises a second public meeting about the new COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "22/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-organises-second-public-meeting-about-new-covid-19-vaccines" }, { "title": "Cyberattack on EMA - update 3", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/cyberattack-ema-update-3" }, { "title": "EMA recommends first COVID-19 vaccine for authorisation in the EU", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "21/12/2020", "last_updated_date": "22/12/2020", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu" }, { "title": "Cyberattack on EMA - update 2", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/cyberattack-ema-update-2" }, { "title": "EMA Management Board: highlights of December 2020 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "18/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2020-meeting" }, { "title": "Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "17/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-assessment-marketing-authorisation-application-modernas-mrna-1273-covid-19-vaccine" }, { "title": "EMA working on COVID-19 and Brexit over holiday period", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "17/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-working-covid-19-brexit-over-holiday-period" }, { "title": "Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "15/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-assessment-biontech-pfizer-bnt162b2-vaccine-marketing-authorisation-application" }, { "title": "Cyberattack on EMA - update 1", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/cyberattack-ema-update-1" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 8-10 December 2020", "press_release": "No", "related_medicine_referral": "Circovac;Innovax-ILT;Galliprant;Ubac;Evalon;Neptra;Vectra Felis;Bovela;Cortavance;Ecoporc Shiga;Gripovac 3;Isemid;Meloxidyl;Nasym;ProZinc;Syvazul BTV;Velactis;Solensia", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "11/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-8-10-december-2020" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020", "press_release": "No", "related_medicine_referral": "Bavencio;Enhertu;Heplisav B;Inrebic;Lumoxiti;Rukobia;Retsevmo;Sibnayal;Tukysa;Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka);Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto);Lenalidomide Krka d.d.;Kirsty (previously Kixelle);Yuflyma;Ogluo;Doptelet;Keytruda;Nplate;Nordimet;Rinvoq;Spravato;Tecentriq;Iscover;Plavix;Artobend;Sunitinib Accord;Veklury", "categories": "Human", "topics": "Biosimilars;Generic and hybrid medicines;Medicines", "news_summary": "Fifteen new medicines recommended for approval", "first_published_date": "11/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-7-10-december-2020" }, { "title": "Cyberattack on the European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/cyberattack-european-medicines-agency" }, { "title": "Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "08/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/joint-strategy-sets-direction-ema-and-eu-medicines-regulatory-agencies-2025" }, { "title": "EMA website briefly unavailable on 3 December 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-3-december-2020" }, { "title": "EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S", "press_release": "No", "related_medicine_referral": "Jcovden (previously COVID-19 Vaccine Janssen)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "01/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-janssens-covid-19-vaccine-ad26cov2s" }, { "title": "EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "01/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-moderna-covid-19-vaccine" }, { "title": "EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "01/12/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-mrna-vaccine-bnt162b2" }, { "title": "Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "27/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-urge-continuation-covid-19-vaccine-trials-longer-term-safety-efficacy-follow" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "27/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-23-26-november-2020" }, { "title": "Call for expressions of interest for Committee for Orphan Medicinal Products (COMP) members positions representing patient organisations", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Rare diseases", "news_summary": "", "first_published_date": "24/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/call-expressions-interest-committee-orphan-medicinal-products-comp-members-positions-representing-patient-organisations" }, { "title": "Workshop on regulatory support for development of orphan medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Early access;Rare diseases;Scientific advice", "news_summary": "", "first_published_date": "23/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/workshop-regulatory-support-development-orphan-medicines" }, { "title": "Update on remdesivir - EMA will evaluate new data from Solidarity trial", "press_release": "No", "related_medicine_referral": "Veklury", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "20/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-remdesivir-ema-will-evaluate-new-data-solidarity-trial" }, { "title": "HMA/EMA statement on approval of vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "20/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/hma-ema-statement-approval-vaccines" }, { "title": "Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment Committee (PRAC) - deadline extended", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "09/11/2020", "last_updated_date": "20/11/2020", "news_url": "https://www.ema.europa.eu/en/news/call-independent-scientific-experts-join-emas-pharmacovigilance-risk-assessment-committee-prac-deadline-extended" }, { "title": "EMA organises public meeting on COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "19/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-organises-public-meeting-covid-19-vaccines" }, { "title": "EMA marks European Antibiotic Awareness Day", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "18/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-marks-european-antibiotic-awareness-day" }, { "title": "EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.", "press_release": "No", "related_medicine_referral": "Spikevax (previously COVID-19 Vaccine Moderna)", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "16/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-mrna-covid-19-vaccine-moderna-biotech-spain-sl" }, { "title": "Emer Cooke takes office as head of EMA", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Antimicrobial resistance;Innovation", "news_summary": "", "first_published_date": "16/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emer-cooke-takes-office-head-ema" }, { "title": "EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Pharmacovigilance", "news_summary": "", "first_published_date": "13/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-publishes-safety-monitoring-plan-guidance-risk-management-planning-covid-19-vaccines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2020", "press_release": "No", "related_medicine_referral": "Phesgo;Roclanda;Onbevzi;Elzonris;Gamifant;Kyprolis;Pradaxa;Tivicay;Trimbow;Xarelto;Xyrem;Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group;Ulipristal acetate 5mg medicinal products;Puldysa;Roctavian;Tibsovo;Xofluza", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "13/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-9-12-november-2020" }, { "title": "Nitrosamines: EMA aligns recommendations for sartans with those for other medicines", "press_release": "No", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "13/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/nitrosamines-ema-aligns-recommendations-sartans-those-other-medicines" }, { "title": "Message from EMA’s outgoing Executive Director, Guido Rasi", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "13/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/message-emas-outgoing-executive-director-guido-rasi" }, { "title": "Ulipristal acetate for uterine fibroids: EMA recommends restricting use", "press_release": "No", "related_medicine_referral": "Ulipristal acetate 5mg medicinal products;Esmya", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "13/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-5 November 2020", "press_release": "No", "related_medicine_referral": "NexGard Combo;Enteroporc Coli;Advocate;Clynav;Sevohale (previously Sevocalm);Equilis Prequenza;Equilis Prequenza Te;Respiporc Flu3;Ecoporc Shiga;Respiporc FLUpan H1N1;Rabitec", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "06/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-3-5-november-2020" }, { "title": "International regulators and WHO join forces to address COVID-19 challenges", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "06/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-who-join-forces-address-covid-19-challenges" }, { "title": "Regulatory information – 1.7% and 1.6% increase of pharmacovigilance fees from 1 November 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Fees;Pharmacovigilance", "news_summary": "", "first_published_date": "04/11/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-17-and-16-increase-pharmacovigilance-fees-1-november-2020" }, { "title": "Extra transparency measures for COVID-19 vaccines and therapeutics", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "30/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/extra-transparency-measures-covid-19-vaccines-therapeutics" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 October 2020", "press_release": "No", "related_medicine_referral": "Ifosfamide solutions", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "30/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-october-2020" }, { "title": "Regulatory update - EMA encourages companies to submit type I variations for 2020 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "29/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2020-end-november" }, { "title": "EMA closed 2 November 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "29/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-2-november-2020" }, { "title": "Strengthening global collaboration on COVID-19 real-world evidence and observational studies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "23/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/strengthening-global-collaboration-covid-19-real-world-evidence-observational-studies" }, { "title": "10th ESVAC report shows continued decrease in sales of veterinary antibiotics", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "21/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/10th-esvac-report-shows-continued-decrease-sales-veterinary-antibiotics" }, { "title": "EMA virtual conference: 25 years of advancing public and animal health", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Herbal;Corporate", "topics": "", "news_summary": "", "first_published_date": "19/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-virtual-conference-25-years-advancing-public-and-animal-health" }, { "title": "First long-acting injectable antiretroviral therapy for HIV recommended for approval", "press_release": "No", "related_medicine_referral": "Rekambys;Vocabria", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-long-acting-injectable-antiretroviral-therapy-hiv-recommended-approval" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020", "press_release": "No", "related_medicine_referral": "Trixeo Aerosphere;Fintepla;Leqvio;Libmeldy;Blincyto;Dupixent;Humira;Opdivo;Tremfya;Edistride;Forxiga;Lacosamide UCB;Vimpat;Oxlumo;Palforzia;Rekambys;Tecartus;Vocabria;Lenalidomide Mylan;Plegridy;Recarbrio;Desloratadine ratiopharm", "categories": "Human", "topics": "Generic and hybrid medicines;Medicines;Referrals", "news_summary": "", "first_published_date": "16/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-october-2020" }, { "title": "First treatment for rare condition primary hyperoxaluria type 1", "press_release": "No", "related_medicine_referral": "Oxlumo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-rare-condition-primary-hyperoxaluria-type-1" }, { "title": "New gene therapy to treat rare genetic disorder metachromatic leukodystrophy", "press_release": "No", "related_medicine_referral": "Libmeldy", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-gene-therapy-treat-rare-genetic-disorder-metachromatic-leukodystrophy" }, { "title": "First CAR-T cell medicine for mantle cell lymphoma", "press_release": "No", "related_medicine_referral": "Tecartus", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-car-t-cell-medicine-mantle-cell-lymphoma" }, { "title": "EMA cancer symposium: New approaches in patient-focused cancer medicine development", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Research and development", "news_summary": "", "first_published_date": "15/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-cancer-symposium-new-approaches-patient-focused-cancer-medicine-development" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 6-7 October 2020", "press_release": "No", "related_medicine_referral": "Innovax-ND-IBD;Arti-Cell Forte;Baycox Iron;Bluevac BTV (previously Bluevac BTV8);Nobivac Myxo-RHD Plus;Respiporc FLUpan H1N1;Simparica;MiPet Easecto;Zycortal;CircoMax Myco;Enteroporc Coli AC;Rexxolide;Nobivac DP Plus;Vectormune FP ILT", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "09/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-6-7-october-2020" }, { "title": "New online platform for scientific advice", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Scientific advice", "news_summary": "", "first_published_date": "07/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-online-platform-scientific-advice" }, { "title": "EMA starts second rolling review of a COVID-19 vaccine", "press_release": "No", "related_medicine_referral": "Comirnaty", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "06/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-second-rolling-review-covid-19-vaccine" }, { "title": "EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "05/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-regulators-fully-uphold-transparency-independence-standards-covid-19-treatments-vaccines" }, { "title": "Highlights of Management Board: October 2020 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "05/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/highlights-management-board-october-2020-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 2020", "press_release": "No", "related_medicine_referral": "Veklury;Ifosfamide solutions", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "02/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-september-1-october-2020" }, { "title": "EMA starts first rolling review of a COVID-19 vaccine in the EU", "press_release": "No", "related_medicine_referral": "Vaxzevria (previously COVID-19 Vaccine AstraZeneca)", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "01/10/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-first-rolling-review-covid-19-vaccine-eu" }, { "title": "Guideline on registry-based studies - launch of public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials;Regulatory and procedural guidance;Scientific guidelines", "news_summary": "", "first_published_date": "24/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/guideline-registry-based-studies-launch-public-consultation" }, { "title": "How incidents with medicines are managed in the EU – a ten-year analysis", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/how-incidents-medicines-are-managed-eu-ten-year-analysis" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020", "press_release": "No", "related_medicine_referral": "Exparel liposomal;MenQuadfi;Nyxthracis (previously Obiltoxaximab SFL);Rivaroxaban Accord;Nyvepria;Phelinun;Elzonris;Gamifant;Upkanz;Deltyba;Fycompa;Flucelvax Tetra;Kalydeco;Lynparza;Olumiant;Opdivo;Orfadin;Supemtek Tetra (previously Supemtek);Symkevi;Tecentriq;Velphoro;Yervoy;Zejula;Ranitidine-containing medicinal products;Zavicefta", "categories": "Human", "topics": "COVID-19;Biosimilars;Generic and hybrid medicines;Medicines;Medicines for use outside the EU", "news_summary": "", "first_published_date": "18/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2020" }, { "title": "EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "18/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-endorses-use-dexamethasone-covid-19-patients-oxygen-or-mechanical-ventilation" }, { "title": "First treatment for rare metabolic disorder alkaptonuria", "press_release": "No", "related_medicine_referral": "Orfadin", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-rare-metabolic-disorder-alkaptonuria" }, { "title": "New treatment for children with chronic kidney disease", "press_release": "No", "related_medicine_referral": "Velphoro", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-children-chronic-kidney-disease" }, { "title": "New oral treatment for moderate to severe atopic dermatitis", "press_release": "No", "related_medicine_referral": "Olumiant", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-oral-treatment-moderate-severe-atopic-dermatitis" }, { "title": "IT systems unavailable from 18 to 20 September 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/it-systems-unavailable-18-20-september-2020" }, { "title": "Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Research and development", "news_summary": "", "first_published_date": "14/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/making-best-use-big-data-public-health-publication-big-data-steering-group-workplan-2020-21" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 8-9 September 2020", "press_release": "No", "related_medicine_referral": "Cytopoint;Nobilis IB Primo QX;Zycortal;Nasym;Nobivac L4;Canigen L4;Suvaxyn Circo;Suvaxyn Circo+MH RTU;Vectra Felis;Vectra 3D;Simparica;MiPet Easecto;Nexgard Spectra;Frontpro (previously Afoxolaner Merial);NexGard;Convenia;Equilis StrepE;Letifend;Forceris;Zolvix;Librela;OvuGel", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "11/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-8-9-september-2020" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2020", "press_release": "No", "related_medicine_referral": "Ulipristal Acetate Gedeon Richter;Ifosfamide solutions;Esmya;Ulipristal acetate 5mg medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "04/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-31-august-3-september-2020" }, { "title": "PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids", "press_release": "No", "related_medicine_referral": "Ulipristal Acetate Gedeon Richter;Esmya;Ulipristal acetate 5mg medicinal products", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "04/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-revoking-marketing-authorisation-ulipristal-acetate-uterine-fibroids" }, { "title": "EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Referrals", "news_summary": "", "first_published_date": "24/07/2020", "last_updated_date": "02/09/2020", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-review-dexamethasone-treating-adults-covid-19-requiring-respiratory-support" }, { "title": "EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "02/09/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-dexamethasone-taw-covid-19" }, { "title": "Communication@EMA – how are we doing?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/08/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/communicationema-how-are-we-doing-0" }, { "title": "Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Research and development", "news_summary": "", "first_published_date": "31/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulatory-workshop-covid-19-therapeutics-2-agreement-acceptable-endpoints-clinical-trials" }, { "title": "Global regulatory workshop on COVID-19 real-world evidence and observational studies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Research and development", "news_summary": "", "first_published_date": "31/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulatory-workshop-covid-19-real-world-evidence-observational-studies" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020", "press_release": "No", "related_medicine_referral": "Adakveo;Arikayce liposomal;Ayvakyt;Blenrep;Calquence;Zynrelef;Jyseleca;Equidacent;Arsenic trioxide medac;Fampridine Accord;Elzonris;Gamifant;Crysvita;Fortacin;HyQvia;Imbruvica;Imfinzi;Kalydeco;Latuda;NovoThirteen;Prezista;Shingrix;Reyataz;Votubia;Rayoqta;Abilify MyCite;Panexcell;Yondelis;Ibuprofen Kabi 400 mg Infusionslösung and associated names", "categories": "Human", "topics": "COVID-19;Biosimilars;Generic and hybrid medicines;Medicines;Medicines for use outside the EU", "news_summary": "", "first_published_date": "24/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-july-2020" }, { "title": "Authorised uses of cancer medicine Yondelis unchanged following review of new data", "press_release": "No", "related_medicine_referral": "Yondelis", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "24/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/authorised-uses-cancer-medicine-yondelis-unchanged-following-review-new-data" }, { "title": "Panexcell Clinical Laboratories: suspension of medicines over flawed studies", "press_release": "No", "related_medicine_referral": "Panexcell", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/panexcell-clinical-laboratories-suspension-medicines-over-flawed-studies" }, { "title": "Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high disease burden", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/vaginal-ring-reduce-risk-hiv-infection-women-non-eu-countries-high-disease-burden" }, { "title": "First antibody-drug conjugate for multiple myeloma patients with limited treatment options", "press_release": "No", "related_medicine_referral": "Blenrep", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-antibody-drug-conjugate-multiple-myeloma-patients-limited-treatment-options" }, { "title": "COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Research and development;Vaccines", "news_summary": "", "first_published_date": "21/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-ema-sets-infrastructure-real-world-monitoring-treatments-and-vaccines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 14-16 July 2020", "press_release": "Yes", "related_medicine_referral": "Increxxa;Tulinovet;Mhyosphere PCV ID;Innovax-ND-ILT;Aivlosin;Posatex;UpCard;Panacur AquaSol;Imrestor", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "17/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-veterinary-use-cvmp-14-16-july-2020" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020", "press_release": "No", "related_medicine_referral": "Ifosfamide solutions;Ulipristal acetate 5mg medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "10/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-july-2020" }, { "title": "International regulators align positions on phase 3 COVID-19 vaccine trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "09/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-align-positions-phase-3-covid-19-vaccine-trials" }, { "title": "EMA finalises opinion on presence of nitrosamines in medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "09/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-finalises-opinion-presence-nitrosamines-medicines" }, { "title": "Workshop: safe use of medicines during pregnancy and breastfeeding", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "08/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/workshop-safe-use-medicines-during-pregnancy-and-breastfeeding" }, { "title": "Launch of public consultation on joint network strategy to 2025", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/launch-public-consultation-joint-network-strategy-2025" }, { "title": "International regulators provide guiding principles for COVID-19 clinical trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials", "news_summary": "", "first_published_date": "01/07/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-provide-guiding-principles-covid-19-clinical-trials" }, { "title": "EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "30/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-korean-ministry-food-drug-safety-share-confidential-covid-19-information" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020", "press_release": "No", "related_medicine_referral": "Idefirix;Veklury;Turalio;Gencebok;Aybintio;Livogiva;Qutavina;Xiidra;Zemdri;Epclusa;Cosentyx;Remsima;Xolair;Zavicefta;Budesonide SUN;Kaftrio;Lumeblue (previously Methylthioninium chloride Cosmo);Sondelbay;Ranitidine-containing medicinal products", "categories": "Human", "topics": "COVID-19;Biosimilars;Generic and hybrid medicines;Medicines", "news_summary": "", "first_published_date": "26/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-june-2020" }, { "title": "New medicine for cystic fibrosis patients", "press_release": "Yes", "related_medicine_referral": "Kaftrio", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-cystic-fibrosis-patients" }, { "title": "New treatment to enable kidney transplant in highly sensitised patients", "press_release": "Yes", "related_medicine_referral": "Idefirix", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-enable-kidney-transplant-highly-sensitised-patients" }, { "title": "First COVID-19 treatment recommended for EU authorisation", "press_release": "Yes", "related_medicine_referral": "Veklury", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "25/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-covid-19-treatment-recommended-eu-authorisation" }, { "title": "Emer Cooke nominated as new EMA Executive Director", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "", "first_published_date": "25/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emer-cooke-nominated-new-ema-executive-director" }, { "title": "Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials", "news_summary": "", "first_published_date": "24/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-discuss-data-requirements-phase-3-trials-covid-19-vaccines" }, { "title": "European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "23/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-regulators-make-recommendations-drawing-lessons-learnt-presence-nitrosamines-sartan-medicines" }, { "title": "Academia developing medicines for rare diseases to receive free EMA scientific advice", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "23/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/academia-developing-medicines-rare-diseases-receive-free-ema-scientific-advice" }, { "title": "European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "22/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-commission-ema-fda-agree-new-priorities-strengthen-their-collaboration-medicines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020", "press_release": "Yes", "related_medicine_referral": "Bluevac BTV (previously Bluevac BTV8);Stronghold Plus;Felisecto Plus;Simparica;Zycortal;Suvaxyn PRRS MLV", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "19/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-16-18-june-2020" }, { "title": "International regulators stress value of safe and effective vaccines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "18/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-stress-value-safe-effective-vaccines" }, { "title": "Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials", "news_summary": "", "first_published_date": "15/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-work-towards-alignment-policy-approaches-and-regulatory-flexibility-during-covid-19-update-4" }, { "title": "Annual report 2019 published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/annual-report-2019-published" }, { "title": "Highlights of Management Board: June 2020 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19;Clinical trials;Governance", "news_summary": "", "first_published_date": "12/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/highlights-management-board-june-2020-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2020", "press_release": "No", "related_medicine_referral": "Ifosfamide solutions;Ulipristal acetate 5mg medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "12/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-june-2020" }, { "title": "Latest data support continued use of ACE inhibitors and ARB medicines during COVID-19 pandemic", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Research and development", "news_summary": "", "first_published_date": "09/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/latest-data-support-continued-use-ace-inhibitors-arb-medicines-during-covid-19-pandemic" }, { "title": "EU actions to support availability of medicines during COVID-19 pandemic – update #7", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "COVID-19;Medicine shortages", "news_summary": "", "first_published_date": "08/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-7" }, { "title": "EMA receives application for conditional authorisation of first COVID-19 treatment in the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "08/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-receives-application-conditional-authorisation-first-covid-19-treatment-eu" }, { "title": "Patients’ and healthcare professionals’ organisations updated on EMA’s response to COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "04/06/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/patients-healthcare-professionals-organisations-updated-emas-response-covid-19" }, { "title": "COVID-19: reminder of the risks of chloroquine and hydroxychloroquine", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "29/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-reminder-risks-chloroquine-and-hydroxychloroquine" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020", "press_release": "No", "related_medicine_referral": "Hepcludex;Mvabea;Piqray;Rozlytrek;Xenleta;Zabdeno;Apixaban Accord;Zercepac;Erlotinib Accord;Fingolimod Mylan;Invokana;Lynparza;Ofev;Sivextro;Taltz;Trumenba;Vokanamet", "categories": "Human", "topics": "COVID-19;Biosimilars;Generic and hybrid medicines;Medicines", "news_summary": "", "first_published_date": "29/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-28-may-2020" }, { "title": "New vaccine for prevention of Ebola virus disease recommended for approval in the European Union", "press_release": "Yes", "related_medicine_referral": "Mvabea;Zabdeno", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "29/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-vaccine-prevention-ebola-virus-disease-recommended-approval-european-union" }, { "title": "Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials;Medicine shortages;Quality of medicines", "news_summary": "", "first_published_date": "28/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-work-towards-alignment-policy-approaches-and-regulatory-flexibility-during-covid-19-update-3" }, { "title": "Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "28/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/essential-work-combat-covid-19-pandemic-continue-during-emas-closure-1-june-2020" }, { "title": "European medicines regulatory network fully mobilised in fight against COVID-19", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "28/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-regulatory-network-fully-mobilised-fight-against-covid-19" }, { "title": "Prospective dialogue between developers and regulators makes for better evidence generation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Scientific advice", "news_summary": "", "first_published_date": "27/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prospective-dialogue-between-developers-and-regulators-makes-better-evidence-generation" }, { "title": "EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials;Quality of medicines;Research and development;Vaccines", "news_summary": "", "first_published_date": "27/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-commissions-independent-research-prepare-real-world-monitoring-covid-19-vaccines" }, { "title": "EMA calls for high-quality observational research in context of COVID-19", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials;Medicines;Research and development", "news_summary": "", "first_published_date": "26/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-calls-high-quality-observational-research-context-covid-19" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 May 2020", "press_release": "Yes", "related_medicine_referral": "Prevexxion RN+HVT+IBD;Prevexxion RN;Zulvac BTV;Leucofeligen FeLV/RCP;Aivlosin;Reconcile;Eryseng Parvo;Eryseng;Rhiniseng;Purevax RC;Purevax RCP;Purevax RCPCh;Purevax RCPCh FeLV;Purevax FeLV;Purevax RCP FeLV;Metacam;Novem;Fortekor Plus;Vectormune ND;Suvaxyn PRRS MLV;Clynav;Draxxin;Isemid;Porcilis ColiClos;Poulvac E. coli;Syvazul BTV;Vectra Felis", "categories": "Veterinary", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "25/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-18-20-may-2020" }, { "title": "Global regulators commit to cooperate on observational research in the context of COVID-19", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Research and development", "news_summary": "", "first_published_date": "20/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-commit-cooperate-observational-research-context-covid-19" }, { "title": "Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials;Medicine shortages", "news_summary": "", "first_published_date": "18/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-work-towards-alignment-policy-approaches-and-regulatory-flexibility-during-covid-19-update-2" }, { "title": "EU actions to support availability of medicines during COVID-19 pandemic – update #6", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "COVID-19;Medicine shortages", "news_summary": "", "first_published_date": "15/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-6" }, { "title": "International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials", "news_summary": "", "first_published_date": "15/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-coordination-needed-encourage-conduct-large-decision-relevant-covid-19-clinical-trials" }, { "title": "Update of EU recommendations for 2020/2021 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Vaccines", "news_summary": "", "first_published_date": "15/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-eu-recommendations-2020-2021-seasonal-flu-vaccine-composition" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May 2020", "press_release": "No", "related_medicine_referral": "Leuprorelin-containing depot medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "15/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-may-2020" }, { "title": "Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "15/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/leuprorelin-depot-medicines-prac-recommends-new-measures-avoid-handling-errors" }, { "title": "EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Compassionate use;Medicines for use outside the EU", "news_summary": "", "first_published_date": "11/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-expanding-remdesivir-compassionate-use-patients-not-mechanical-ventilation" }, { "title": "EU actions to support availability of medicines during COVID-19 pandemic – update #5", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "COVID-19;Medicine shortages", "news_summary": "", "first_published_date": "08/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-5" }, { "title": "Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "05/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-work-towards-alignment-policy-approaches-and-regulatory-flexibility-during-covid-19" }, { "title": "COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Research and development;Vaccines", "news_summary": "", "first_published_date": "04/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-how-ema-fast-tracks-development-support-approval-medicines-vaccines" }, { "title": "Regulatory flexibility to ensure availability of veterinary medicines during COVID-19 pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "COVID-19;Regulatory and procedural guidance;Medicine shortages", "news_summary": "", "first_published_date": "04/05/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-flexibility-ensure-availability-veterinary-medicines-during-covid-19-pandemic" }, { "title": "EMA starts rolling review of remdesivir for COVID-19", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "30/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-rolling-review-remdesivir-covid-19" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020", "press_release": "No", "related_medicine_referral": "Daurismo;Enerzair Breezhaler;Reblozyl;Zimbus Breezhaler;Fingolimod Accord;Insulin aspart Sanofi;Cabazitaxel Accord;Byannli (previously Paliperidone Janssen-Cilag International);Braftovi;Cablivi;Carmustine medac (previously Carmustine Obvius);Ecalta;Harvoni;Kalydeco;Sovaldi;Suboxone;Taltz;Ultomiris;Darzalex;Keytruda;Budesonide SUN;Carbamazepin Tillomed;Picato;Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products;Ranitidine-containing medicinal products", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "30/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-28-30-april-2020" }, { "title": "Risks of Picato for actinic keratosis outweigh benefits", "press_release": "Yes", "related_medicine_referral": "Picato;Picato", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "30/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/risks-picato-actinic-keratosis-outweigh-benefits" }, { "title": "EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and flucytosine", "press_release": "Yes", "related_medicine_referral": "Ecansya (previously Capecitabine Krka);Capecitabine Teva;Capecitabine Medac;Capecitabine Accord;Teysuno;Xeloda", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "30/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommendations-dpd-testing-prior-treatment-fluorouracil-capecitabine-tegafur-and-flucytosine" }, { "title": "First triple combination therapy for asthma with optional electronic sensor", "press_release": "Yes", "related_medicine_referral": "Enerzair Breezhaler", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "30/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-triple-combination-therapy-asthma-optional-electronic-sensor" }, { "title": "Suspension of ranitidine medicines in the EU", "press_release": "Yes", "related_medicine_referral": "Ranitidine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "30/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/suspension-ranitidine-medicines-eu" }, { "title": "EU actions to support availability of medicines during COVID-19 pandemic – update #4", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicine shortages", "news_summary": "", "first_published_date": "30/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-4" }, { "title": "International regulators pledge collective support to combat COVID-19 pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "28/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-pledge-collective-support-combat-covid-19-pandemic" }, { "title": "EU actions to support availability of medicines during COVID-19 pandemic – update #3", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "COVID-19;Medicine shortages", "news_summary": "", "first_published_date": "24/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-3" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 April 2020", "press_release": "Yes", "related_medicine_referral": "Meloxidyl;Imrestor;Bravecto;Novaquin;UpCard;Baycox Iron;Improvac;Respiporc FLUpan H1N1;SevoFlo;Zeleris;Suvaxyn Circo+MH RTU", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "24/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-21-23-april-2020" }, { "title": "Reporting suspected side effects of medicines in patients with COVID-19", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Pharmacovigilance;Quality of medicines", "news_summary": "", "first_published_date": "24/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/reporting-suspected-side-effects-medicines-patients-covid-19" }, { "title": "Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 27 April and on 1 May 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "23/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/essential-work-combat-covid-19-pandemic-continue-during-emas-closure-27-april-and-1-may-2020" }, { "title": "COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "23/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-reminder-risk-serious-side-effects-chloroquine-hydroxychloroquine" }, { "title": "Launch of enhanced monitoring system for availability of medicines used for treating COVID-19", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicine shortages", "news_summary": "", "first_published_date": "21/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/launch-enhanced-monitoring-system-availability-medicines-used-treating-covid-19" }, { "title": "Update to guidance on regulatory expectations in the context of COVID-19 pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "20/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-guidance-regulatory-expectations-context-covid-19-pandemic" }, { "title": "EU actions to support availability of medicines during COVID-19 pandemic – update #2", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicine shortages", "news_summary": "", "first_published_date": "20/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-2" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 April 2020", "press_release": "No", "related_medicine_referral": "Picato", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "17/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-14-17-april-2020" }, { "title": "EMA review of Picato concludes medicine’s risks outweigh its benefits", "press_release": "Yes", "related_medicine_referral": "Picato", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "17/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-review-picato-concludes-medicines-risks-outweigh-its-benefits" }, { "title": "Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Research and development", "news_summary": "", "first_published_date": "16/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-icmra-global-regulatory-workshop-covid-19-observational-studies-real-world-data" }, { "title": "Guidance on regulatory requirements in the context of the COVID-19 pandemic", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "10/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/guidance-regulatory-requirements-context-covid-19-pandemic" }, { "title": "Update on EU actions to support availability of medicines during COVID-19 pandemic", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "10/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-eu-actions-support-availability-medicines-during-covid-19-pandemic" }, { "title": "EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "09/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-establishes-task-force-take-quick-coordinated-regulatory-action-related-covid-19-medicines" }, { "title": "Global regulators stress need for robust evidence on COVID-19 treatments", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials;Compassionate use;Medicines", "news_summary": "", "first_published_date": "09/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-stress-need-robust-evidence-covid-19-treatments" }, { "title": "Global regulators discuss observational studies of real world data for COVID-19 medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19", "news_summary": "", "first_published_date": "07/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-discuss-observational-studies-real-world-data-covid-19-medicines" }, { "title": "Essential work to combat the COVID-19 pandemic to continue during EMA's Easter break from 9 to 13 April 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "COVID-19", "news_summary": "", "first_published_date": "07/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/essential-work-combat-covid-19-pandemic-continue-during-emas-easter-break-9-13-april-2020" }, { "title": "EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicine shortages;Medicines", "news_summary": "", "first_published_date": "06/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-authorities-agree-new-measures-support-availability-medicines-used-covid-19-pandemic" }, { "title": "EMA provides recommendations on compassionate use of remdesivir for COVID-19", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines for use outside the EU", "news_summary": "", "first_published_date": "03/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-provides-recommendations-compassionate-use-remdesivir-covid-19" }, { "title": "International regulators discuss available knowledge supporting COVID-19 medicine development", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Research and development;Vaccines", "news_summary": "", "first_published_date": "03/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/international-regulators-discuss-available-knowledge-supporting-covid-19-medicine-development" }, { "title": "COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials;Research and development", "news_summary": "", "first_published_date": "01/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-chloroquine-and-hydroxychloroquine-only-be-used-clinical-trials-or-emergency-use-programmes" }, { "title": "Regulatory information - 1.6% increase in fees from 1 April 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Fees", "news_summary": "", "first_published_date": "01/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-16-increase-fees-1-april-2020" }, { "title": "EU recommendations for 2020/2021 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "01/04/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2020-2021-seasonal-flu-vaccine-composition" }, { "title": "Advancing regulatory science in the EU – new strategy adopted", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Innovation;Research and development", "news_summary": "", "first_published_date": "31/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/advancing-regulatory-science-eu-new-strategy-adopted" }, { "title": "Update on treatments and vaccines against COVID-19 under development", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "31/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-treatments-and-vaccines-against-covid-19-under-development" }, { "title": "EMA to issue electronic certificates for medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "", "news_summary": "", "first_published_date": "30/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-issue-electronic-certificates-medicines" }, { "title": "EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "27/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-advises-continued-use-medicines-hypertension-heart-or-kidney-disease-during-covid-19-pandemic" }, { "title": "No change to product information for breast cancer medicine Tyverb following re-assessment of data", "press_release": "Yes", "related_medicine_referral": "Tyverb", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "27/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/no-change-product-information-breast-cancer-medicine-tyverb-following-re-assessment-data" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)", "press_release": "No", "related_medicine_referral": "Atectura Breezhaler;Bemrist Breezhaler;Fluad Tetra;Dovprela (previously Pretomanid FGK);Sarclisa;Zeposia;Zolgensma;Nepexto;Adcetris;Cosentyx;Intelence;Jorveza;Kineret;Ruconest;Tyverb;Fosfomycin-containing medicinal products;Methocarbamol / paracetamol-containing medicinal products;Doxorubicin Hydrochloride Tillomed;Budesonide SUN;Rituximab Mabion", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "27/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-2020-updated" }, { "title": "New gene therapy to treat spinal muscular atrophy (corrected)", "press_release": "Yes", "related_medicine_referral": "Zolgensma", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "27/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-gene-therapy-treat-spinal-muscular-atrophy-corrected" }, { "title": "Restrictions in use of cyproterone due to meningioma risk", "press_release": "Yes", "related_medicine_referral": "Cyproterone-containing medicinal products", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "27/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/restrictions-use-cyproterone-due-meningioma-risk-0" }, { "title": "Recommendations to restrict use of fosfomycin antibiotics", "press_release": "Yes", "related_medicine_referral": "Fosfomycin-containing medicinal products", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "27/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/recommendations-restrict-use-fosfomycin-antibiotics" }, { "title": "No change is needed in use of direct oral anticoagulants following EMA-funded study", "press_release": "Yes", "related_medicine_referral": "Pradaxa;Eliquis;Xarelto", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "27/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/no-change-needed-use-direct-oral-anticoagulants-following-ema-funded-study" }, { "title": "Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks", "press_release": "Yes", "related_medicine_referral": "Methocarbamol / paracetamol-containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "27/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/benefits-medicines-containing-combination-methocarbamol-paracetamol-continue-outweigh-risks" }, { "title": "Ten years of MUMS: 22 new veterinary medicines authorised for minor uses and minor species", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Veterinary limited markets", "news_summary": "", "first_published_date": "25/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ten-years-mums-22-new-veterinary-medicines-authorised-minor-uses-and-minor-species" }, { "title": "Global regulators map out data requirements for phase 1 COVID-19 vaccine trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines;Vaccines", "news_summary": "", "first_published_date": "24/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-regulators-map-out-data-requirements-phase-1-covid-19-vaccine-trials" }, { "title": "COVID-19: Beware of falsified medicines from unregistered websites", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Medicines", "news_summary": "", "first_published_date": "24/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-beware-falsified-medicines-unregistered-websites" }, { "title": "Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials;Research and development;Vaccines", "news_summary": "", "first_published_date": "20/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020", "press_release": "Yes", "related_medicine_referral": "Lydaxx;Vectra Felis;Vectra 3D;Equisolon;Meloxoral;Porcilis PCV ID;Galliprant;Cytopoint;Evalon;Exzolt;Vaxxitek HVT+IBD", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "20/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-17-18-march-2020" }, { "title": "EMA Management Board – highlights of March 2020 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Clinical trials;Governance;Maximum residue limit;Pharmacovigilance", "news_summary": "", "first_published_date": "20/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2020-meeting" }, { "title": "Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Clinical trials", "news_summary": "", "first_published_date": "19/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/call-pool-research-resources-large-multi-centre-multi-arm-clinical-trials-generate-sound-evidence-covid-19-treatments" }, { "title": "First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "COVID-19;Research and development;Vaccines", "news_summary": "", "first_published_date": "18/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-regulatory-workshop-covid-19-facilitates-global-collaboration-vaccine-development" }, { "title": "EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "18/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-gives-advice-use-non-steroidal-anti-inflammatories-covid-19" }, { "title": "COVID-19: developers of medicines or vaccines to benefit from free scientific advice", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Early access;Research and development;Scientific advice", "news_summary": "", "first_published_date": "13/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-developers-medicines-or-vaccines-benefit-free-scientific-advice" }, { "title": "Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk", "press_release": "Yes", "related_medicine_referral": "Ulipristal acetate 5mg medicinal products;Ulipristal Acetate Gedeon Richter;Esmya", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "13/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/suspension-ulipristal-acetate-uterine-fibroids-during-ongoing-ema-review-liver-injury-risk" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020", "press_release": "No", "related_medicine_referral": "Esmya;Ulipristal Acetate Gedeon Richter;Xeloda;Teysuno;Capecitabine Accord;Capecitabine Medac;Capecitabine Teva;Ecansya (previously Capecitabine Krka);Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products;Ifosfamide solutions;Ulipristal acetate 5mg medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "13/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-march-2020" }, { "title": "COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "COVID-19", "news_summary": "", "first_published_date": "11/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/covid-19-ema-meetings-delegates-and-experts-will-be-held-virtually-until-end-april-2020" }, { "title": "Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "COVID-19;Medicine shortages", "news_summary": "", "first_published_date": "10/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/addressing-potential-impact-novel-coronavirus-disease-covid-19-medicines-supply-eu" }, { "title": "Regulatory information – adjusted fees for applications to EMA from 1 April 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/03/2020", "last_updated_date": "06/03/2020", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2020" }, { "title": "Emiel van Galen elected as chair of the Committee for Herbal Medicinal Products", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "04/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emiel-van-galen-elected-chair-committee-herbal-medicinal-products" }, { "title": "Update on nitrosamines in EU medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "03/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-nitrosamines-eu-medicines" }, { "title": "EMA organisational changes come into effect", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "", "first_published_date": "02/03/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-organisational-changes-come-effect" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020", "press_release": "No", "related_medicine_referral": "Alunbrig;Ofev;Otezla;Emgality;Opdivo;Yervoy;Axumin;Yondelis;Fetcroja;Tigecycline Accord;Entyvio", "categories": "Human", "topics": "Generic and hybrid medicines;Medicines;Referrals", "news_summary": "", "first_published_date": "28/02/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-february-2020" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 February 2020", "press_release": "Yes", "related_medicine_referral": "Vectormune FP ILT + AE;Tulaven;Tulissin;Clynav;Porcilis PCV M Hyo;Imrestor;Evicto;Panacur AquaSol;Bravecto;Bravecto Plus;Exzolt;Vaxxitek HVT+IBD;Canigen L4;Innovax-ILT;Sileo;Arti-Cell Forte;Forceris;Fortekor Plus;Imrestor;Incurin;Previcox;Suvaxyn PRRS MLV", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "21/02/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-18-20-february-2020" }, { "title": "Restrictions in use of cyproterone due to meningioma risk", "press_release": "Yes", "related_medicine_referral": "Cyproterone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "14/02/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/restrictions-use-cyproterone-due-meningioma-risk" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2020", "press_release": "No", "related_medicine_referral": "Picato;Cyproterone-containing medicinal products;Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products;Leuprorelin-containing depot medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "14/02/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-february-2020" }, { "title": "Public access to suspected side effect reports of veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "12/02/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/public-access-suspected-side-effect-reports-veterinary-medicines" }, { "title": "New video launched: How does EMA support SMEs?", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "", "news_summary": "", "first_published_date": "06/02/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-video-launched-how-does-ema-support-smes" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 January 2020", "press_release": "Yes", "related_medicine_referral": "Innovax-ND-IBD;Rabitec;Bravecto;Clevor;Advocate;Credelio;Metacam;Novem;Activyl;Clomicalm;Evant;Loxicom;Neocolipor;Oxybee;Semintra;Startvac;Suvaxyn Circo;Syvazul BTV;Vepured;Versican Plus DHPPi/L4;Zulvac SBV", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "24/01/2020", "last_updated_date": "06/02/2020", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-21-23-january-2020" }, { "title": "EMA to support development of vaccines and treatments for novel coronavirus disease (COVID-19)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "COVID-19;Vaccines", "news_summary": "", "first_published_date": "04/02/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-support-development-vaccines-and-treatments-novel-coronavirus-disease-covid-19" }, { "title": "EU flags are up in EMA’s new building in Amsterdam", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/02/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-flags-are-emas-new-building-amsterdam" }, { "title": "UK withdrawal from the EU on 31 January 2020", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "31/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/uk-withdrawal-eu-31-january-2020" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020", "press_release": "No", "related_medicine_referral": "Keytruda;Suliqua;Nustendi;Rezolsta;Vaxchora;Nilemdo;Rybelsus;Ameluz;Staquis;Cinacalcet Accordpharma;Arsenic trioxide Mylan;Givlaari;Nubeqa;MabThera;Azacitidine Mylan;Trepulmix;Lyumjev (previously Liumjev);GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.);Ruxience;Azacitidine betapharm;Venclyxto;Idhifa", "categories": "Human", "topics": "Biosimilars;Generic and hybrid medicines;Medicines;Referrals;Vaccines", "news_summary": "", "first_published_date": "31/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-january-2020" }, { "title": "First treatment for acute hepatic porphyria", "press_release": "Yes", "related_medicine_referral": "Givlaari", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "31/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-acute-hepatic-porphyria" }, { "title": "First oral GLP-1 treatment for type 2 diabetes", "press_release": "Yes", "related_medicine_referral": "Rybelsus", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "31/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-oral-glp-1-treatment-type-2-diabetes" }, { "title": "Key principles for the use of electronic product information for EU medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Product information", "news_summary": "", "first_published_date": "29/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/key-principles-use-electronic-product-information-eu-medicines" }, { "title": "Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "28/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/categorisation-antibiotics-used-animals-promotes-responsible-use-protect-public-and-animal-health" }, { "title": "EMA celebrates 25 years advancing public and animal health", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-celebrates-25-years-advancing-public-and-animal-health" }, { "title": "Martina Schüssler-Lenz re-elected as chair of Committee for Advanced Therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "24/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/martina-schussler-lenz-re-elected-chair-committee-advanced-therapies" }, { "title": "Court of Justice upholds EMA’s approach to transparency", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Clinical trials", "news_summary": "", "first_published_date": "22/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/court-justice-upholds-emas-approach-transparency" }, { "title": "Ten recommendations to unlock the potential of big data for public health in the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "20/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ten-recommendations-unlock-potential-big-data-public-health-eu" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020", "press_release": "No", "related_medicine_referral": "Picato;Estradiol-containing (0.01% w/w) medicinal products for topical use;Cyproterone-containing medicinal products;Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products;Leuprorelin-containing depot medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "17/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-january-2020" }, { "title": "EMA suspends Picato as a precaution while review of skin cancer risk continues", "press_release": "Yes", "related_medicine_referral": "Picato", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "17/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-suspends-picato-precaution-while-review-skin-cancer-risk-continues" }, { "title": "PRAC confirms four-week limit for use of high-strength estradiol creams", "press_release": "Yes", "related_medicine_referral": "Estradiol-containing (0.01% w/w) medicinal products for topical use", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "17/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prac-confirms-four-week-limit-use-high-strength-estradiol-creams" }, { "title": "EMA welcomes new Head of Information Management Division", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "", "first_published_date": "16/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-welcomes-new-head-information-management-division" }, { "title": "Mandatory use of international standard for the reporting of side effects to improve safety of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "15/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/mandatory-use-international-standard-reporting-side-effects-improve-safety-medicines" }, { "title": "Veterinary medicines: highlights of 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "10/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2019" }, { "title": "Human medicines: highlights of 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "09/01/2020", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2019" }, { "title": "EMA Management Board: highlights of December 2019 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/12/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2019-meeting" }, { "title": "European Medicines Agency closed 21 December 2019 to 5 January 2020", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "18/12/2019", "last_updated_date": "18/12/2019", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-21-december-2019-5-january-2020" }, { "title": "Launch of international pilot programme on inspection of manufacturers of sterile medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "17/12/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/launch-international-pilot-programme-inspection-manufacturers-sterile-medicines" }, { "title": "4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety system", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "17/12/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/4-year-overview-pharmacovigilance-activities-eu-shows-robust-effective-medicines-safety-system" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019", "press_release": "No", "related_medicine_referral": "Akynzeo;Dificlir;Cyramza;Darzalex;Erleada;Sirturo;Beovu;Amsparity;Recarbrio;Azacitidine Accord;Stelara;Vyndaqel", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "13/12/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-9-12-december-2019" }, { "title": "Six-year review shows success of the EU signal management system in improving safe use of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "11/12/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/six-year-review-shows-success-eu-signal-management-system-improving-safe-use-medicines" }, { "title": "How will pharmacovigilance look in 2030?", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "10/12/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/how-will-pharmacovigilance-look-2030" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 December 2019", "press_release": "Yes", "related_medicine_referral": "Onsior;Eravac;Zactran;Apoquel;Circovac;Nobilis IB 4-91;Zulvac SBV;Innovax-ILT;Simparica;MiPet Easecto;Bravecto;Bravecto Plus;Velactis;Coliprotec F4/F18;Nexgard Spectra;Rheumocam;Ubac;Versican Plus DHPPi;Versican Plus DHPPi/L4;Versican Plus L4;Versican Plus Pi;Versican Plus Pi/L4;Versican Plus Pi/L4R", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "06/12/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-3-5-december-2019" }, { "title": "EMA update on metformin diabetes medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "06/12/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-update-metformin-diabetes-medicines" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "29/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-november-2019" }, { "title": "‘Regulatory science to 2025’: live broadcast of post-consultation workshop on veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-science-2025-live-broadcast-post-consultation-workshop-veterinary-medicines" }, { "title": "Dutch authorities hand over final building to EMA in Amsterdam", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/dutch-authorities-hand-over-final-building-ema-amsterdam" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated)", "press_release": "No", "related_medicine_referral": "Isturisa;Mayzent;Polivy;Sunosi;Tavlesse;Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan);Deferasirox Accord;Linhaliq;Luxceptar;Revlimid;Kadcyla;Opsumit;Lemtrada;Xeljanz", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "15/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-november-2019-updated" }, { "title": "EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots", "press_release": "Yes", "related_medicine_referral": "Xeljanz", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "15/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-xeljanz-be-used-caution-patients-high-risk-blood-clots" }, { "title": "Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada", "press_release": "Yes", "related_medicine_referral": "Lemtrada", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "15/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/measures-minimise-risk-serious-side-effects-multiple-sclerosis-medicine-lemtrada" }, { "title": "First vaccine to protect against Ebola", "press_release": "Yes", "related_medicine_referral": "Ervebo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/10/2019", "last_updated_date": "14/11/2019", "news_url": "https://www.ema.europa.eu/en/news/first-vaccine-protect-against-ebola" }, { "title": "Regulators’ advice can make a difference for faster patient access to highly innovative therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulators-advice-can-make-difference-faster-patient-access-highly-innovative-therapies" }, { "title": "‘Regulatory science to 2025’: live broadcast of post-consultation workshop", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-science-2025-live-broadcast-post-consultation-workshop" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 November 2019", "press_release": "Yes", "related_medicine_referral": "Aservo EquiHaler;Stelfonta;Bravecto Plus;Bravecto;Exzolt;Poulvac E. coli;ProZinc;Vectormune ND;Coliprotec F4;Zulvac SBV;Letifend;Osurnia;Simparica;MiPet Easecto;Bluevac BTV (previously Bluevac BTV8);Bovela;Bovilis Blue-8;Clynav;Halagon;Inflacam;Porcilis PCV;Respiporc FLUpan H1N1;SevoFlo;Velactis", "categories": "Veterinary", "topics": "Data on medicines", "news_summary": "", "first_published_date": "08/11/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-november-2019" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019", "press_release": "No", "related_medicine_referral": "Xeljanz;Lemtrada;Cyproterone-containing medicinal products;Estradiol-containing (0.01% w/w) medicinal products for topical use;Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products;Leuprorelin-containing depot medicinal products;Picato", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "31/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-31-october-2019" }, { "title": "EMA closed 1 November 2019", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "31/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-1-november-2019" }, { "title": "Regulatory update - EMA encourages companies to submit type I variations for 2019 by end of November 2019", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2019-end-november-2019" }, { "title": "Dialogue with Chinese authorities on medicine regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/dialogue-chinese-authorities-medicine-regulation" }, { "title": "Enhancing consistency in wording of therapeutic indications to support healthcare decision-making", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Product information", "news_summary": "", "first_published_date": "21/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/enhancing-consistency-wording-therapeutic-indications-support-healthcare-decision-making" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019", "press_release": "No", "related_medicine_referral": "Baqsimi;Ervebo;Quofenix;Rinvoq;Cegfila (previously Pegfilgrastim Mundipharma);Evenity;Vanflyta;Darzalex;Kalydeco;Keytruda;Toujeo (previously Optisulin);Revolade;Translarna;Ekesivy;Nuzyra;Xyndari;Spravato", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "18/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2019" }, { "title": "First non-injectable treatment for severe low blood sugar levels", "press_release": "Yes", "related_medicine_referral": "Baqsimi", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-non-injectable-treatment-severe-low-blood-sugar-levels" }, { "title": "European countries increase commitment to responsible antibiotic use in animals", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "15/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-countries-increase-commitment-responsible-antibiotic-use-animals" }, { "title": "European Network of Paediatric Research at EMA elects new chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "14/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-network-paediatric-research-ema-elects-new-chair" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 2019", "press_release": "Yes", "related_medicine_referral": "Neptra;Mirataz;Exzolt;Suvaxyn Circo;Suvaxyn Circo+MH RTU;Meloxidolor;Novaquin;Sedadex;Prevomax;Easotic;Equip WNV (previously Duvaxyn WNV);Halocur;Letifend;MS-H Vaccine;Naxcel;Nobivac Myxo-RHD;Porcilis PCV M Hyo;Zeleris;Bravecto", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "11/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-october-2019" }, { "title": "EMA Management Board: highlights of October 2019 meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2019-meeting" }, { "title": "Four-week limit for use of high-strength estradiol creams", "press_release": "Yes", "related_medicine_referral": "Estradiol-containing (0.01% w/w) medicinal products for topical use", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "04/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/four-week-limit-use-high-strength-estradiol-creams" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 September-3 October 2019", "press_release": "No", "related_medicine_referral": "Estradiol-containing (0.01% w/w) medicinal products for topical use", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines", "news_summary": "", "first_published_date": "04/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-30-september-3-october-2019" }, { "title": "How to ensure that novel analytic methods are fit for decision-making", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/10/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/how-ensure-novel-analytic-methods-are-fit-decision-making" }, { "title": "Change of name of liposomal medicines at high risk of medication errors", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines;Quality of medicines", "news_summary": "", "first_published_date": "26/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/change-name-liposomal-medicines-high-risk-medication-errors" }, { "title": "EMA advises companies on steps to take to avoid nitrosamines in human medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines;Referrals", "news_summary": "", "first_published_date": "26/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-advises-companies-steps-take-avoid-nitrosamines-human-medicines" }, { "title": "Working parties for healthcare professionals and for patients and consumers elect new co-chairs", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "25/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/working-parties-healthcare-professionals-and-patients-and-consumers-elect-new-co-chairs-0" }, { "title": "EMA’s work on new veterinary regulation advances", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "23/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emas-work-new-veterinary-regulation-advances" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019", "press_release": "No", "related_medicine_referral": "Docetaxel Zentiva (previously Docetaxel Winthrop);Taxotere;Qtrilmet;Xospata;Benlysta;Arsenic trioxide Accord;Rhokiinsa;Remsima;Trulicity;Ivozall;Bortezomib Fresenius Kabi;Lucentis;Senstend;Bavencio;Dupixent;Lucentis", "categories": "Human", "topics": "Generic and hybrid medicines;Medicines;Rare diseases", "news_summary": "", "first_published_date": "20/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-september-2019" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2019", "press_release": "Yes", "related_medicine_referral": "Bravecto;Posatex;Rhiniseng;Quadrisol;Vectra Felis;Velactis;Bovela;Nexgard Spectra;Suvaxyn CSF Marker;Bravecto Plus;Coxevac;Osurnia;Cytopoint;Vectormune ND;Gumbohatch;Nobivac Myxo-RHD Plus", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-september-2019" }, { "title": "EMA to provide guidance on avoiding nitrosamines in human medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "13/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-provide-guidance-avoiding-nitrosamines-human-medicines" }, { "title": "EMA to review ranitidine medicines following detection of NDMA", "press_release": "Yes", "related_medicine_referral": "Ranitidine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Quality of medicines;Referrals", "news_summary": "", "first_published_date": "13/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines-following-detection-ndma" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019", "press_release": "No", "related_medicine_referral": "Picato", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "06/09/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-september-2019" }, { "title": "Global public meeting on draft ICH guideline on clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "30/08/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/global-public-meeting-draft-ich-guideline-clinical-trials" }, { "title": "New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases", "press_release": "Yes", "related_medicine_referral": "Methotrexate containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "23/08/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-measures-avoid-potentially-fatal-dosing-errors-methotrexate-inflammatory-diseases" }, { "title": "EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "16/08/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-fda-analysis-shows-high-degree-alignment-marketing-application-decisions-between-eu-and-us" }, { "title": "EMA closed 15 August 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/08/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-15-august-2019" }, { "title": "Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "31/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/supporting-medicine-developers-generating-quality-data-packages-early-access-approaches-prime-and-breakthrough-therapies-workshop-report-published" }, { "title": "Names of liposomal medicines to be changed to avoid medication errors", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medication error;Medicines", "news_summary": "", "first_published_date": "31/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/names-liposomal-medicines-be-changed-avoid-medication-errors" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019", "press_release": "No", "related_medicine_referral": "Epidyolex;Inbrija;Trogarzo;Vitrakvi;Deferasirox Mylan;Evenity;Empliciti;Keytruda;Lonsurf;Lucentis;Stelara;Soliris;Tecentriq;Zerbaxa;Translarna;Revolade;Gilenya", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2019" }, { "title": "Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy", "press_release": "Yes", "related_medicine_referral": "Gilenya", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/updated-restrictions-gilenya-multiple-sclerosis-medicine-not-be-used-pregnancy" }, { "title": "First ‘histology-independent’ treatment for solid tumours with a specific gene mutation", "press_release": "Yes", "related_medicine_referral": "Vitrakvi", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-histology-independent-treatment-solid-tumours-specific-gene-mutation" }, { "title": "Paediatric Committee elects Koenraad Norga as its new chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "24/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/paediatric-committee-elects-koenraad-norga-its-new-chair" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019", "press_release": "Yes", "related_medicine_referral": "Simparica Trio;NexGard;Nexgard Spectra;Broadline", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-16-18-july-2019" }, { "title": "EMA takes note of the European Ombudsman’s decision on pre-submission activities", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Scientific advice", "news_summary": "", "first_published_date": "19/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-takes-note-european-ombudsmans-decision-pre-submission-activities" }, { "title": "PRAC recommends new measures to avoid dosing errors with methotrexate", "press_release": "Yes", "related_medicine_referral": "Methotrexate containing medicinal products", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "12/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-new-measures-avoid-dosing-errors-methotrexate" }, { "title": "EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "12/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-and-us-reach-milestone-mutual-recognition-inspections-medicines-manufacturers" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2019", "press_release": "No", "related_medicine_referral": "Estradiol-containing (0.01% w/w) medicinal products for topical use;Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products;Lemtrada;Leuprorelin-containing depot medicinal products;Xeljanz;Cyproterone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "11/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-july-2019" }, { "title": "Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities (ICMRA)", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/guido-rasi-elected-chair-international-coalition-medicines-regulatory-authorities-icmra" }, { "title": "EMA confirms WeWork as new sub-tenant for 30 Churchill Place; EMA also settles court case with Canary Wharf Group", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-wework-new-sub-tenant-30-churchill-place-ema-also-settles-court-case-canary-wharf-group" }, { "title": "Medicine shortages: EU network takes steps to improve reporting and communication", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "04/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/medicine-shortages-eu-network-takes-steps-improve-reporting-and-communication" }, { "title": "Call for all sponsors to publish clinical trial results in EU database", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Clinical trials", "news_summary": "", "first_published_date": "03/07/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/call-all-sponsors-publish-clinical-trial-results-eu-database" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019", "press_release": "No", "related_medicine_referral": "Giapreza;Azacitidine Celgene;Lacosamide UCB;Evenity;Xyndari;ABP 710;Cyramza;Dupixent;Ebymect;Edistride;Fiasp;Forxiga;Imbruvica;Revolade;Tecentriq;Victoza;Xigduo;Zinforo;Translarna;Bacterial lysates-containing medicinal products indicated for respiratory conditions;ABP 710;Flebogamma DIF (previously Flebogammadif)", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "28/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2019" }, { "title": "Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections", "press_release": "Yes", "related_medicine_referral": "Bacterial lysates-containing medicinal products indicated for respiratory conditions", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "28/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/bacterial-lysate-medicines-respiratory-conditions-be-used-only-prevention-recurrent-infections" }, { "title": "New treatment for children with type 2 diabetes", "press_release": "Yes", "related_medicine_referral": "Victoza", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "28/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-children-type-2-diabetes" }, { "title": "One additional country to benefit from EU-US mutual recognition agreement for inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "27/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/one-additional-country-benefit-eu-us-mutual-recognition-agreement-inspections" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 June 2019", "press_release": "Yes", "related_medicine_referral": "Advocate;Meloxidyl;Suprelorin;Suvaxyn Circo;Suvaxyn Circo+MH RTU;Inflacam;Rheumocam", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "21/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-18-20-june-2019" }, { "title": "Highlights of Management Board meeting: June 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/highlights-management-board-meeting-june-2019" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2019", "press_release": "No", "related_medicine_referral": "Leuprorelin-containing depot medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "14/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-june-2019" }, { "title": "Two additional countries to benefit from EU-US mutual recognition agreement for inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "11/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections-1" }, { "title": "EMA closed 10 June 2019", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-10-june-2019" }, { "title": "Strengthening engagement between EMA and general practitioners", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Governance", "news_summary": "", "first_published_date": "06/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/strengthening-engagement-between-ema-and-general-practitioners" }, { "title": "Consultation on draft guideline on quality requirements for medical devices in combination products", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Quality of medicines;Medical devices", "news_summary": "", "first_published_date": "03/06/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/consultation-draft-guideline-quality-requirements-medical-devices-combination-products" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019", "press_release": "No", "related_medicine_referral": "Cufence;LysaKare;Posaconazole AHCL;Posaconazole Accord;Xyndari;Doxolipad;Ambrisentan Zentiva;Radicava;Methocarbamol / paracetamol-containing medicinal products", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "29/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-29-may-2019" }, { "title": "EMA closed 30-31 May 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-30-31-may-2019" }, { "title": "EMA facilitates early engagement with medicine developers to combat antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "24/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-facilitates-early-engagement-medicine-developers-combat-antimicrobial-resistance" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-22 May 2019", "press_release": "Yes", "related_medicine_referral": "Bravecto Plus;Clynav;Clomicalm;Cytopoint;Ingelvac CircoFLEX;Melovem;Porcilis PCV M Hyo;MiPet Easecto;Stronghold Plus;Simparica;Fevaxyn Pentofel;Canigen L4;Nobivac L4;Halagon;Locatim (previously Serinucoli);Poulvac E. coli;Sileo;Vectra Felis;Zuprevo;Draxxin;Evicto;Nasym", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "24/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-21-22-may-2019" }, { "title": "Update of EU recommendations for 2019–2020 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "20/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-eu-recommendations-2019-2020-seasonal-flu-vaccine-composition-0" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019", "press_release": "No", "related_medicine_referral": "Xeljanz;Fenspiride containing medicinal products;Estradiol-containing (0.01% w/w) medicinal products for topical use;Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products;Lemtrada;Methotrexate containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "17/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-may-2019" }, { "title": "Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs", "press_release": "Yes", "related_medicine_referral": "Xeljanz;Xeljanz", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "17/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/restrictions-use-xeljanz-while-ema-reviews-risk-blood-clots-lungs" }, { "title": "Withdrawal of marketing authorisations for fenspiride medicines", "press_release": "Yes", "related_medicine_referral": "Fenspiride containing medicinal products", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "17/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/withdrawal-marketing-authorisations-fenspiride-medicines" }, { "title": "European Medicines Agency closed 9 May 2019", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "07/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-9-may-2019" }, { "title": "Working together for safe medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "06/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/working-together-safe-medicines-eu" }, { "title": "EMA annual report 2018 published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/05/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-annual-report-2018-published" }, { "title": "Two additional countries to benefit from EU-US mutual recognition agreement for inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "30/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections-0" }, { "title": "Re-analysis of data on use of breast cancer medicine Tyverb following treatment with trastuzumab", "press_release": "Yes", "related_medicine_referral": "Tyverb", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "30/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/re-analysis-data-use-breast-cancer-medicine-tyverb-following-treatment-trastuzumab" }, { "title": "European Medicines Agency closed 1 May 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-may-2019" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019", "press_release": "No", "related_medicine_referral": "Doptelet;Dovato;Esperoct;Libtayo;Nuceiva;Sixmo;Talzenna;Ultomiris;Grasustek;Ambrisentan Viatris (previously Ambrisentan Mylan);Striascan;Temybric Ellipta;Xromi;Cabazitaxel Teva;Lynparza;Lartruvo", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "26/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-april-2019" }, { "title": "New long-lasting implant to treat opioid dependence", "press_release": "Yes", "related_medicine_referral": "Sixmo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-long-lasting-implant-treat-opioid-dependence" }, { "title": "EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo", "press_release": "Yes", "related_medicine_referral": "Lartruvo;Lartruvo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-withdrawal-marketing-authorisation-cancer-medicine-lartruvo" }, { "title": "EMA regrets to learn of the passing of Dr Eric Abadie, former CHMP Chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-regrets-learn-passing-dr-eric-abadie-former-chmp-chair" }, { "title": "European Immunization Week 2019: statement by Executive Director Guido Rasi", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "24/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-immunization-week-2019-statement-executive-director-guido-rasi" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 15-16 April 2019", "press_release": "Yes", "related_medicine_referral": "Suvaxyn PRRS MLV;Broadline;Porcilis PCV M Hyo;Leucogen;Leucofeligen FeLV/RCP;Nobivac LeuFel;Osurnia;Respiporc FLUpan H1N1;SevoFlo;Suvaxyn Circo+MH RTU;Virbagen Omega;Zeleris;Cytopoint", "categories": "Veterinary", "topics": "Data on medicines", "news_summary": "", "first_published_date": "23/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-15-16-april-2019" }, { "title": "EMA closed 18-22 April 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-18-22-april-2019" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019", "press_release": "No", "related_medicine_referral": "Estradiol-containing (0.01% w/w) medicinal products for topical use;Lemtrada", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "12/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2019" }, { "title": "Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing", "press_release": "Yes", "related_medicine_referral": "Lemtrada;Lemtrada", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "12/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/use-multiple-sclerosis-medicine-lemtrada-restricted-while-ema-review-ongoing" }, { "title": "Update of EU recommendations for 2019/2020 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "12/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-eu-recommendations-2019-2020-seasonal-flu-vaccine-composition" }, { "title": "The role of regulators in establishing added benefit of novel therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Research and development", "news_summary": "", "first_published_date": "11/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/role-regulators-establishing-added-benefit-novel-therapies" }, { "title": "EU recommendations for 2019/2020 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Vaccines", "news_summary": "", "first_published_date": "01/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2019-2020-seasonal-flu-vaccine-composition" }, { "title": "Regulatory information – 1.7% increase of fees from 1 April 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Fees", "news_summary": "", "first_published_date": "01/04/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-17-increase-fees-1-april-2019" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019", "press_release": "No", "related_medicine_referral": "Zynteglo;Adenuric;Imnovid (previously Pomalidomide Celgene);Mozobil;Revlimid;Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction;Septanest and associated names", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "29/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-28-march-2019" }, { "title": "EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack", "press_release": "Yes", "related_medicine_referral": "Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "29/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-omega-3-fatty-acid-medicines-are-not-effective-preventing-further-heart-problems-after-heart-attack" }, { "title": "New gene therapy to treat rare inherited blood condition", "press_release": "Yes", "related_medicine_referral": "Zynteglo", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "29/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-gene-therapy-treat-rare-inherited-blood-condition" }, { "title": "20 years of sampling and testing programme for medicines authorised for the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "28/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/20-years-sampling-and-testing-programme-medicines-authorised-eu" }, { "title": "New EudraVigilance system improves reporting of side effects and detection of safety signals", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "27/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-eudravigilance-system-improves-reporting-side-effects-detection-safety-signals" }, { "title": "Questions & answers: EU actions to prevent medicine shortages due to Brexit", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "Brexit;Medicine shortages", "news_summary": "", "first_published_date": "26/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/questions-answers-eu-actions-prevent-medicine-shortages-due-brexit" }, { "title": "IT systems unavailable from 30 March to 1 April 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/it-systems-unavailable-30-march-1-april-2019" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019", "press_release": "Yes", "related_medicine_referral": "Frontpro (previously Afoxolaner Merial);Baycox Iron;Innovax-ND-IBD;ProZinc;Vectra 3D;MS-H Vaccine;Clynav;Cytopoint;Simparica;MiPet Easecto;Nobilis IB Primo QX;Suvaxyn PCV;Versican Plus Pi/L4R;CaniLeish;Cimalgex;Evalon;Letifend;Procox;Veraflox", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "22/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-march-2019" }, { "title": "EMA Management Board: highlights of March 2019 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2019-meeting" }, { "title": "Management Board re-elects Christa Wirthumer-Hoche as chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "", "first_published_date": "21/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/management-board-re-elects-christa-wirthumer-hoche-chair" }, { "title": "Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis", "press_release": "Yes", "related_medicine_referral": "Xeljanz", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "20/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/increased-risk-blood-clots-lungs-and-death-higher-dose-xeljanz-tofacitinib-rheumatoid-arthritis" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019", "press_release": "Yes", "related_medicine_referral": "Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "15/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-12-15-march-2019" }, { "title": "EMA now operating from Amsterdam", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "11/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-now-operating-amsterdam" }, { "title": "Regulatory information – adjusted fees for applications to EMA from 1 April 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Fees", "news_summary": "", "first_published_date": "01/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2019" }, { "title": "New add-on treatment to insulin for treatment of certain patients with type 1 diabetes", "press_release": "Yes", "related_medicine_referral": "Zynquista", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-add-treatment-insulin-treatment-certain-patients-type-1-diabetes" }, { "title": "First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban", "press_release": "Yes", "related_medicine_referral": "Ondexxya", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-antidote-reversal-anticoagulation-factor-xa-inhibitors-apixaban-and-rivaroxaban" }, { "title": "CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/chmp-recommends-authorisation-new-treatment-phenylketonuria-rare-inherited-metabolic-disease" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019", "press_release": "No", "related_medicine_referral": "Dupixent;Lynparza;Viread;Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.);Trydonis;Dectova;Lorviqua;Ondexxya;Skyrizi;Waylivra;Zynquista;Syner-Kinase and associated names", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "01/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-28-february-2019" }, { "title": "First treatment for rare disease characterised by high levels of triglycerides in blood", "press_release": "Yes", "related_medicine_referral": "Waylivra", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "01/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-rare-disease-characterised-high-levels-triglycerides-blood" }, { "title": "Change of time zone due to EMA's relocation in March 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Governance", "news_summary": "", "first_published_date": "01/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/change-time-zone-due-emas-relocation-march-2019" }, { "title": "New add-on treatment for patients with severe asthma", "press_release": "Yes", "related_medicine_referral": "Dupixent", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/03/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-add-treatment-patients-severe-asthma" }, { "title": "First guidance on new rules for certain medical devices", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medical devices", "news_summary": "", "first_published_date": "28/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-guidance-new-rules-certain-medical-devices" }, { "title": "Procedural update on submission of Type I variations to EMA in March, April and May 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Brexit", "news_summary": "", "first_published_date": "26/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/procedural-update-submission-type-i-variations-ema-march-april-and-may-2019" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 February 2019", "press_release": "Yes", "related_medicine_referral": "HorStem;Chanhold;Felisecto Plus;Forceris;ReproCyc ParvoFLEX;Letifend;MS-H Vaccine;Zycortal;Exzolt;Fortekor Plus;Galliprant;NexGard;ProteqFlu;ProteqFlu-Te;Semintra;VarroMed;Eravac", "categories": "Veterinary", "topics": "Data on medicines", "news_summary": "", "first_published_date": "22/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-february-2019" }, { "title": "EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "21/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-and-switzerland-improve-information-sharing-good-manufacturing-practice-through-use-eudragmdp-database" }, { "title": "Suspension of fenspiride medicines due to potential risk of heart rhythm problems", "press_release": "Yes", "related_medicine_referral": "Fenspiride containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "15/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/suspension-fenspiride-medicines-due-potential-risk-heart-rhythm-problems" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "15/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-february-2019" }, { "title": "Role of big data for evaluation and supervision of medicines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines", "news_summary": "", "first_published_date": "15/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/role-big-data-evaluation-and-supervision-medicines-eu" }, { "title": "Two additional countries to benefit from EU-US mutual recognition agreement for inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "11/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections" }, { "title": "New online platform for parallel distribution", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "11/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-online-platform-parallel-distribution" }, { "title": "EMA launches checklist to facilitate validation for initial marketing authorisation applications", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "08/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-launches-checklist-facilitate-validation-initial-marketing-authorisation-applications" }, { "title": "New safety features for medicines sold in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "08/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-safety-features-medicines-sold-eu" }, { "title": "Risk classification of antimicrobials used in animals opens for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "05/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/risk-classification-antimicrobials-used-animals-opens-public-consultation" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 2019", "press_release": "No", "related_medicine_referral": "Ajovy;Vizimpro;Atazanavir Krka;Febuxostat Krka;Idacio;Kromeya;Doxolipad;Orencia;Hemlibra;Keytruda;MabThera;Maviret;Praluent;Tecentriq;Edistride;Forxiga;Cavoley;Efgratin;Lartruvo;Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction;Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group;Lartruvo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "01/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-28-31-january-2019" }, { "title": "Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "01/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/sartan-medicines-companies-review-manufacturing-processes-avoid-presence-nitrosamine-impurities" }, { "title": "First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes", "press_release": "Yes", "related_medicine_referral": "Edistride;Forxiga", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "01/02/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-oral-add-treatment-insulin-treatment-certain-patients-type-1-diabetes" }, { "title": "Public consultation on key principles for the electronic product information of EU medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines;Product information", "news_summary": "", "first_published_date": "31/01/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-key-principles-electronic-product-information-eu-medicines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 22-24 January 2019", "press_release": "Yes", "related_medicine_referral": "Purevax RC;Purevax RCP;Purevax RCP FeLV;Purevax RCPCh FeLV;Purevax RCPCh;Versican Plus DHPPi;Versican Plus Pi;Bovela;Certifect;Innovax-ND-IBD;Prac-tic;Sedadex;Stronghold Plus;Suvaxyn Circo;Suvaxyn PRRS MLV;Zulvac SBV;Nexgard Spectra;Fungitraxx", "categories": "Veterinary", "topics": "Data on medicines", "news_summary": "", "first_published_date": "25/01/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-22-24-january-2019" }, { "title": "EMA relocation updates", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "23/01/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-relocation-updates" }, { "title": "No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life", "press_release": "Yes", "related_medicine_referral": "Lartruvo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/01/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/no-new-patients-should-start-treatment-lartruvo-after-study-shows-cancer-medicine-does-not-prolong-life" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "18/01/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-14-17-january-2019" }, { "title": "Revised guideline aims to strengthen global approach to development of new antibacterial medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "14/01/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/revised-guideline-aims-strengthen-global-approach-development-new-antibacterial-medicines" }, { "title": "Veterinary medicines: highlights of 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "04/01/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2018" }, { "title": "Human medicines: highlights of 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "04/01/2019", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2018" }, { "title": "European Medicines Agency closed 21 December 2018 to 2 January 2019", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/12/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-21-december-2018-2-january-2019" }, { "title": "Regulatory Science to 2025 – launch of six-month public consultation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Innovation;Research and development", "news_summary": "", "first_published_date": "19/12/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-science-2025-launch-six-month-public-consultation" }, { "title": "Responding to emerging health threats in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Scientific advice;Vaccines", "news_summary": "", "first_published_date": "17/12/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/responding-emerging-health-threats-eu" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018", "press_release": "No", "related_medicine_referral": "Besremi;Mulpleo (previously Lusutrombopag Shionogi);Rizmoic;Vantobra (previously Tobramycin PARI);Trecondi;Zirabev;Miglustat Dipharma;Fyzoclad;Canakinumab Novartis;Adcetris;Rapiscan;Rubraca;Simponi;Sprycel;Trimbow;Metamizole containing medicinal products;Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction;Fosfomycin-containing medicinal products", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "14/12/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-december-2018" }, { "title": "EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding", "press_release": "Yes", "related_medicine_referral": "Metamizole containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "14/12/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding" }, { "title": "Omega-3 fatty acid medicines no longer considered effective in preventing heart disease", "press_release": "Yes", "related_medicine_referral": "Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction", "categories": "Human", "topics": "Pharmacovigilance;Referrals", "news_summary": "", "first_published_date": "14/12/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/omega-3-fatty-acid-medicines-no-longer-considered-effective-preventing-heart-disease" }, { "title": "EMA Management Board: highlights of December 2018 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "14/12/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2018-meeting" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 December 2018", "press_release": "Yes", "related_medicine_referral": "Kriptazen;Evant;Zulvac BTV", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "07/12/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-4-6-december-2018" }, { "title": "Revised guideline to assess risk of human medicines for the environment", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Research and development;Scientific guidelines", "news_summary": "", "first_published_date": "30/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/revised-guideline-assess-risk-human-medicines-environment" }, { "title": "Data from patient registries to replace clinical trials in previously untreated haemophilia patients", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Research and development;Scientific guidelines", "news_summary": "", "first_published_date": "30/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/data-patient-registries-replace-clinical-trials-previously-untreated-haemophilia-patients" }, { "title": "Meeting highlights from EMA’s safety committee (PRAC) 26-29 November 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "30/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-emas-safety-committee-prac-26-29-november-2018" }, { "title": "Workshop: advancing regulatory science to 2025 for veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Research and development", "news_summary": "", "first_published_date": "29/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/workshop-advancing-regulatory-science-2025-veterinary-medicines" }, { "title": "Five additional countries to benefit from EU-US mutual recognition agreement for inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "29/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/five-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections" }, { "title": "IT systems unavailable from 30 November to 3 December 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/it-systems-unavailable-30-november-3-december-2018" }, { "title": "Towards electronic product information for EU medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Product information", "news_summary": "", "first_published_date": "21/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/towards-electronic-product-information-eu-medicines" }, { "title": "Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Early access;Quality of medicines;Research and development", "news_summary": "", "first_published_date": "20/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/workshop-how-better-support-medicine-developers-generation-and-preparation-quality-data-packages-prime-and-breakthrough-therapy-applications" }, { "title": "Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "19/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/valsartan-mylan-laboratories-india-can-no-longer-be-used-eu-medicines-due-ndea-impurity" }, { "title": "Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics", "press_release": "Yes", "related_medicine_referral": "Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "16/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/disabling-potentially-permanent-side-effects-lead-suspension-or-restrictions-quinolone-fluoroquinolone-antibiotics" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018", "press_release": "No", "related_medicine_referral": "Erleada;Ghryvelin (previously Macimorelin Aeterna Zentaris);Silodosin Recordati;Blincyto;Opdivo;Yervoy;Kisqali;MabThera;Orkambi;Ravicti;Tecentriq;Quinolone- and fluoroquinolone-containing medicinal products;Diclofenac Sodium Spray Gel 4%;Diotop capsules", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-november-2018" }, { "title": "CHMP recommends first oral-only treatment for sleeping sickness", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Medicines for use outside the EU", "news_summary": "", "first_published_date": "16/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/chmp-recommends-first-oral-only-treatment-sleeping-sickness" }, { "title": "EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "13/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/emas-brexit-plans-ensure-agencys-focus-medicines-evaluation-and-supervision" }, { "title": "EMA gives guidance on safety monitoring of medicines used in children", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Paediatrics;Pharmacovigilance", "news_summary": "", "first_published_date": "13/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-gives-guidance-safety-monitoring-medicines-used-children" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2018", "press_release": "Yes", "related_medicine_referral": "Aftovaxpur DOE;Syvazul BTV;Isemid", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "09/11/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-november-2018" }, { "title": "Meeting highlights from EMA’s safety committee (PRAC) 29-31 October 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "31/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-emas-safety-committee-prac-29-31-october-2018" }, { "title": "Working with stakeholders to improve availability of medicines in the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Medicine shortages", "news_summary": "", "first_published_date": "31/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/working-stakeholders-improve-availability-medicines-eu" }, { "title": "EMA closed 1-2 November 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-1-2-november-2018" }, { "title": "EMA experts awarded for excellence in standards development", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Data on medicines", "news_summary": "", "first_published_date": "26/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-experts-awarded-excellence-standards-development" }, { "title": "Regulatory update - EMA encourages companies to submit type I variations for 2018 by end of November 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Brexit;Regulatory and procedural guidance", "news_summary": "", "first_published_date": "26/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2018-end-november-2018" }, { "title": "Revised timelines for certificates of pharmaceutical products (CPPs) and temporary arrangements during EMA’s relocation", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "23/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/revised-timelines-certificates-pharmaceutical-products-cpps-and-temporary-arrangements-during-emas-relocation" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018", "press_release": "No", "related_medicine_referral": "Kalydeco;Keytruda;NovoSeven;Dengvaxia;Flucelvax Tetra;Namuscla;Takhzyro;Paclitaxel Hetero and associated names;Perlinring and associated names", "categories": "Human", "topics": "Biosimilars;Medicines;Rare diseases;Referrals;Vaccines", "news_summary": "", "first_published_date": "19/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-october-2018" }, { "title": "New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin", "press_release": "Yes", "related_medicine_referral": "Takhzyro", "categories": "Human", "topics": "Medicines;Rare diseases", "news_summary": "", "first_published_date": "19/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-hereditary-angioedema-rare-disease-causing-swelling-beneath-skin" }, { "title": "First treatment for rare inherited muscle contraction disorders", "press_release": "Yes", "related_medicine_referral": "Namuscla", "categories": "Human", "topics": "Medicines;Rare diseases", "news_summary": "", "first_published_date": "19/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-rare-inherited-muscle-contraction-disorders" }, { "title": "First vaccine for prevention of dengue", "press_release": "Yes", "related_medicine_referral": "Dengvaxia", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "19/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/first-vaccine-prevention-dengue" }, { "title": "Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Fees;Pharmacovigilance", "news_summary": "", "first_published_date": "18/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-pharmacovigilance-applications-18-october-2018-0" }, { "title": "Shaping regulatory science to 2025", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Innovation;Research and development", "news_summary": "", "first_published_date": "17/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/shaping-regulatory-science-2025" }, { "title": "Sales of antibiotics for use in food-producing animals drop across the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "15/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/sales-antibiotics-use-food-producing-animals-drop-across-eu" }, { "title": "EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "Referrals", "news_summary": "", "first_published_date": "15/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-authorities-take-further-action-ongoing-review-sartans-zheijiang-huahai-placed-under-increased-supervision-aurobindo-pharma-stopped-supplying-irbesartan-eu" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 October 2018", "press_release": "Yes", "related_medicine_referral": "Longrange;Bravecto;NexGard;HorStem", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "12/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-october-2018" }, { "title": "Update on EMA’s Brexit preparedness", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary;Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "09/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/update-emas-brexit-preparedness" }, { "title": "Fluoroquinolone and quinolone antibiotics: PRAC recommends new restrictions on use following review of disabling and potentially long-lasting side effects", "press_release": "Yes", "related_medicine_referral": "Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Research and development", "news_summary": "", "first_published_date": "05/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/fluoroquinolone-quinolone-antibiotics-prac-recommends-new-restrictions-use-following-review-disabling-potentially-long-lasting-side-effects" }, { "title": "EMA Management Board: highlights of October 2018 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2018-meeting" }, { "title": "Boosting the development of medicines for children", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "02/10/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/boosting-development-medicines-children" }, { "title": "EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan: EMA and national authorities considering impact on other active substances produced at the site", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "28/09/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/eu-inspection-finds-zhejiang-huahai-site-non-compliant-manufacture-valsartan-ema-national-authorities-considering-impact-other-active-substances-produced-site" }, { "title": "Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "28/09/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-pharmacovigilance-applications-18-october-2018" }, { "title": "Harnessing the potential of real world data through a ‘learning healthcare system’", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "27/09/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/harnessing-potential-real-world-data-through-learning-healthcare-system" }, { "title": "EMA launches new corporate website", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/09/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-launches-new-corporate-website" }, { "title": "EMA to launch new corporate website on 27 September 2018", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/09/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-launch-new-corporate-website-27-september-2018" }, { "title": "Companies stepping up efforts to ensure medicine supply post Brexit", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "24/09/2018", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/companies-stepping-efforts-ensure-medicine-supply-post-brexit" }, { "title": "New gene therapy for rare inherited disorder causing vision loss recommended for approval", "press_release": "Yes", "related_medicine_referral": "Luxturna", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/09/2018", "last_updated_date": "21/09/2018", "news_url": "https://www.ema.europa.eu/en/news/new-gene-therapy-rare-inherited-disorder-causing-vision-loss-recommended-approval" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018", "press_release": "No", "related_medicine_referral": "Yervoy;Pelmeg;Fulphila;Ziextenzo;Trelegy Ellipta;Elebrato Ellipta;Poteligeo;Luxturna;Pifeltro;Delstrigo;Alunbrig;Jivi;Venclyxto;Blincyto;Gilenya;Emgality;Treprostinil SciPharm Sàrl;RoActemra;Elebrato Ellipta;Trelegy Ellipta;Cabometyx;Vaborem;Buvidal;Xtandi;Opdivo;Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group;Entolimod TMC;Apealea", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/09/2018", "last_updated_date": "21/09/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-september-2018" }, { "title": "Valsartan: review of impurities extended to other sartan medicines", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/09/2018", "last_updated_date": "21/09/2018", "news_url": "https://www.ema.europa.eu/en/news/valsartan-review-impurities-extended-other-sartan-medicines" }, { "title": "New medicine for the prevention of migraine", "press_release": "Yes", "related_medicine_referral": "Emgality", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/09/2018", "last_updated_date": "21/09/2018", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-prevention-migraine" }, { "title": "New medicine to treat infections in adults", "press_release": "Yes", "related_medicine_referral": "Vaborem", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/09/2018", "last_updated_date": "21/09/2018", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-treat-infections-adults" }, { "title": "Portugal to also benefit from EU-US mutual recognition agreement for inspections", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/09/2018", "last_updated_date": "20/09/2018", "news_url": "https://www.ema.europa.eu/en/news/portugal-also-benefit-eu-us-mutual-recognition-agreement-inspections" }, { "title": "EMA's Committee for Medicinal Products for Human Use (CHMP) elects new chair", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/09/2018", "last_updated_date": "18/09/2018", "news_url": "https://www.ema.europa.eu/en/news/emas-committee-medicinal-products-human-use-chmp-elects-new-chair" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2018", "press_release": "Yes", "related_medicine_referral": "Inflacam;Easotic;Rhiniseng;Nobilis IB 4-91;Cytopoint;Zeleris;Nobilis IB Primo QX;Meloxidolor;Letifend;Versican Plus Pi/L4R;Versican Plus Pi/L4;Versican Plus Pi;Versican Plus L4;Versican Plus DHPPi/L4;Versican Plus DHPPi;Versican Plus DHPPi/L4R;Nexgard Spectra;NexGard;Econor;Zactran;Respiporc FLUpan H1N1;Porcilis PCV M Hyo;Osurnia;Rheumocam", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/09/2018", "last_updated_date": "14/09/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-september-2018" }, { "title": "Committee for Orphan Medicinal Products (COMP) elects new chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Rare diseases", "news_summary": "", "first_published_date": "13/09/2018", "last_updated_date": "13/09/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-comp-elects-new-chair" }, { "title": "Improving understanding of biosimilars in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Biosimilars", "news_summary": "", "first_published_date": "13/09/2018", "last_updated_date": "13/09/2018", "news_url": "https://www.ema.europa.eu/en/news/improving-understanding-biosimilars-eu" }, { "title": "Update on review of valsartan medicines: risk from NDMA remains low, a related substance NDEA also being investigated", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "Medicines;Referrals", "news_summary": "", "first_published_date": "13/09/2018", "last_updated_date": "13/09/2018", "news_url": "https://www.ema.europa.eu/en/news/update-review-valsartan-medicines-risk-ndma-remains-low-related-substance-ndea-also-being-investigated" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 September 2018", "press_release": "No", "related_medicine_referral": "Quinolone- and fluoroquinolone-containing medicinal products;Methotrexate containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "07/09/2018", "last_updated_date": "07/09/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-september-2018" }, { "title": "Development of medicines for rare diseases", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/08/2018", "last_updated_date": "31/08/2018", "news_url": "https://www.ema.europa.eu/en/news/development-medicines-rare-diseases" }, { "title": "Towards improving the availability of medicines in the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/08/2018", "last_updated_date": "29/08/2018", "news_url": "https://www.ema.europa.eu/en/news/towards-improving-availability-medicines-eu" }, { "title": "Fostering medicines for children", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "28/08/2018", "last_updated_date": "28/08/2018", "news_url": "https://www.ema.europa.eu/en/news/fostering-medicines-children" }, { "title": "European Medicines Agency closed 27 August 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "23/08/2018", "last_updated_date": "23/08/2018", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-27-august-2018" }, { "title": "Keeping medicines safe", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/08/2018", "last_updated_date": "22/08/2018", "news_url": "https://www.ema.europa.eu/en/news/keeping-medicines-safe" }, { "title": "Update on medicines containing valsartan from Zhejiang Tianyu: company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/08/2018", "last_updated_date": "20/08/2018", "news_url": "https://www.ema.europa.eu/en/news/update-medicines-containing-valsartan-zhejiang-tianyu-company-no-longer-authorised-manufacture-valsartan-active-substance-eu-medicines-due-presence-ndma" }, { "title": "How are new medicines approved by EMA?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/08/2018", "last_updated_date": "15/08/2018", "news_url": "https://www.ema.europa.eu/en/news/how-are-new-medicines-approved-ema" }, { "title": "Update on review of valsartan medicines due to detection of NDMA: EMA reviewing valsartan produced by another company Zhejiang Tianyu", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "10/08/2018", "last_updated_date": "10/08/2018", "news_url": "https://www.ema.europa.eu/en/news/update-review-valsartan-medicines-due-detection-ndma-ema-reviewing-valsartan-produced-another-company-zhejiang-tianyu" }, { "title": "EMA: working for every patient in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/08/2018", "last_updated_date": "08/08/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-working-every-patient-europe" }, { "title": "Esmya: new measures to minimise risk of rare but serious liver injury", "press_release": "Yes", "related_medicine_referral": "Esmya;Esmya", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "08/08/2018", "last_updated_date": "08/08/2018", "news_url": "https://www.ema.europa.eu/en/news/esmya-new-measures-minimise-risk-rare-serious-liver-injury-0" }, { "title": "Update on review of recalled valsartan medicines: preliminary assessment of possible risk to patients", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "02/08/2018", "last_updated_date": "02/08/2018", "news_url": "https://www.ema.europa.eu/en/news/update-review-recalled-valsartan-medicines-preliminary-assessment-possible-risk-patients" }, { "title": "Brexit preparedness: EMA to further temporarily scale back and suspend activities", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "01/08/2018", "last_updated_date": "01/08/2018", "news_url": "https://www.ema.europa.eu/en/news/brexit-preparedness-ema-further-temporarily-scale-back-suspend-activities" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018", "press_release": "No", "related_medicine_referral": "Apealea;Braftovi;Symkevi;Opdivo;Sutent;Raligize;Yervoy;Opdivo;Xarelto;Viekirax;Tafinlar;Revolade;Nucala;Mekinist;Keytruda;Kalydeco;Gilenya;Epoetin Alfa Hexal;Darzalex;Blincyto;Binocrit;Abseamed;Eladynos;Dexxience;Kigabeq;Udenyca;Pelgraz;Hulio;Lenalidomide Accord;Gefitinib Mylan;Deferiprone Lipomed;Xerava;Verzenios;Symkevi;Slenyto;Onpattro;Mektovi;Imfinzi;Ilumetri;Xofigo", "categories": "Human", "topics": "", "news_summary": "Sixteen medicines recommended for approval, including two orphans", "first_published_date": "27/07/2018", "last_updated_date": "27/07/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-july-2018" }, { "title": "New medicine for hereditary rare disease", "press_release": "Yes", "related_medicine_referral": "Onpattro", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/07/2018", "last_updated_date": "27/07/2018", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-hereditary-rare-disease" }, { "title": "Two new paediatric-use marketing authorisations recommended by CHMP", "press_release": "Yes", "related_medicine_referral": "Kigabeq;Slenyto", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/07/2018", "last_updated_date": "27/07/2018", "news_url": "https://www.ema.europa.eu/en/news/two-new-paediatric-use-marketing-authorisations-recommended-chmp" }, { "title": "EMA restricts use of prostate cancer medicine Xofigo", "press_release": "Yes", "related_medicine_referral": "Xofigo;Xofigo", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/07/2018", "last_updated_date": "27/07/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-restricts-use-prostate-cancer-medicine-xofigo" }, { "title": "IT systems unavailable from 27 to 30 July 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/07/2018", "last_updated_date": "25/07/2018", "news_url": "https://www.ema.europa.eu/en/news/it-systems-unavailable-27-30-july-2018" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018", "press_release": "Yes", "related_medicine_referral": "Inflacam;Broadline;Rheumocam", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/07/2018", "last_updated_date": "20/07/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-17-19-july-2018" }, { "title": "EU and Japan reinforce their collaboration on inspections of medicine manufacturers", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "18/07/2018", "last_updated_date": "18/07/2018", "news_url": "https://www.ema.europa.eu/en/news/eu-japan-reinforce-their-collaboration-inspections-medicine-manufacturers" }, { "title": "Update on review of valsartan medicines following detection of impurity in active substance: assessing potential impact on patients is priority", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "17/07/2018", "last_updated_date": "17/07/2018", "news_url": "https://www.ema.europa.eu/en/news/update-review-valsartan-medicines-following-detection-impurity-active-substance-assessing-potential-impact-patients-priority" }, { "title": "EMA's proactive publication of clinical data a success", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/07/2018", "last_updated_date": "16/07/2018", "news_url": "https://www.ema.europa.eu/en/news/emas-proactive-publication-clinical-data-success" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018", "press_release": "No", "related_medicine_referral": "Methotrexate containing medicinal products;Xofigo;Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/07/2018", "last_updated_date": "13/07/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-july-2018" }, { "title": "EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) elects new Chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "11/07/2018", "last_updated_date": "11/07/2018", "news_url": "https://www.ema.europa.eu/en/news/emas-pharmacovigilance-risk-assessment-committee-prac-elects-new-chair" }, { "title": "EMA identifies gaps in industry preparedness for Brexit", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "10/07/2018", "last_updated_date": "10/07/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-identifies-gaps-industry-preparedness-brexit" }, { "title": "EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity: some valsartan medicines being recalled across the EU", "press_release": "Yes", "related_medicine_referral": "Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "05/07/2018", "last_updated_date": "05/07/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity-some-valsartan-medicines-being-recalled-across-eu" }, { "title": "First two CAR-T cell medicines recommended for approval in the European Union", "press_release": "Yes", "related_medicine_referral": "Kymriah;Yescarta", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/06/2018", "last_updated_date": "29/06/2018", "news_url": "https://www.ema.europa.eu/en/news/first-two-car-t-cell-medicines-recommended-approval-european-union" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018", "press_release": "No", "related_medicine_referral": "Cablivi;Duzallo;Graspa;Nerlynx;Opdivo;RoActemra;Rapamune;Lenvima;Jinarc;Inovelon;Dexdor;Vyxeos liposomal (previously Vyxeos);Veyvondi;Ulipristal Acetate Gedeon Richter;Mepsevii;Yescarta;Kymriah;Septanest and associated names;Bacterial lysates-containing medicinal products indicated for respiratory conditions", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/06/2018", "last_updated_date": "29/06/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-28-june-2018" }, { "title": "Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients", "press_release": "Yes", "related_medicine_referral": "Hydroxyethyl starch (HES) containing medicinal products", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/06/2018", "last_updated_date": "29/06/2018", "news_url": "https://www.ema.europa.eu/en/news/hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19–21 June 2018", "press_release": "Yes", "related_medicine_referral": "Arti-Cell Forte;Hydrocortisone aceponate Ecuphar (previously Cortacare);Horse Allo 20;Vectra 3D;Equioxx;Circovac;BTVPUR;Nobivac LeuFel;Leucogen;Leucofeligen FeLV/RCP;Longrange", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "22/06/2018", "last_updated_date": "22/06/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-june-2018" }, { "title": "Reinforced EU/US collaboration on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/06/2018", "last_updated_date": "22/06/2018", "news_url": "https://www.ema.europa.eu/en/news/reinforced-eu-us-collaboration-medicines" }, { "title": "First stem cell-based veterinary medicine recommended for marketing authorisation", "press_release": "Yes", "related_medicine_referral": "Arti-Cell Forte", "categories": "Veterinary", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "22/06/2018", "last_updated_date": "22/06/2018", "news_url": "https://www.ema.europa.eu/en/news/first-stem-cell-based-veterinary-medicine-recommended-marketing-authorisation" }, { "title": "Interested in joining the Committee for Advanced Therapies (CAT) to represent patients' associations or clinicians?", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "21/06/2018", "last_updated_date": "21/06/2018", "news_url": "https://www.ema.europa.eu/en/news/interested-joining-committee-advanced-therapies-cat-represent-patients-associations-or-clinicians" }, { "title": "Modernising the orphan designation process", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "news_url": "https://www.ema.europa.eu/en/news/modernising-orphan-designation-process" }, { "title": "Guidance for pharmaceutical companies to prepare for UK's withdrawal from EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "19/06/2018", "last_updated_date": "19/06/2018", "news_url": "https://www.ema.europa.eu/en/news/guidance-pharmaceutical-companies-prepare-uks-withdrawal-eu" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018", "press_release": "No", "related_medicine_referral": "Quinolone- and fluoroquinolone-containing medicinal products;Xofigo;Methotrexate containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "15/06/2018", "last_updated_date": "15/06/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-june-2018" }, { "title": "IT systems unavailable from 15 to 18 June 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/06/2018", "last_updated_date": "14/06/2018", "news_url": "https://www.ema.europa.eu/en/news/it-systems-unavailable-15-18-june-2018" }, { "title": "Highlights of 100th Management Board meeting: June 2018", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/06/2018", "last_updated_date": "07/06/2018", "news_url": "https://www.ema.europa.eu/en/news/highlights-100th-management-board-meeting-june-2018" }, { "title": "Changes to submission and assessment of maximum residue limits of veterinary medicines in foods", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/06/2018", "last_updated_date": "07/06/2018", "news_url": "https://www.ema.europa.eu/en/news/changes-submission-assessment-maximum-residue-limits-veterinary-medicines-foods" }, { "title": "Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience", "press_release": "Yes", "related_medicine_referral": "Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/06/2018", "last_updated_date": "07/06/2018", "news_url": "https://www.ema.europa.eu/en/news/public-hearing-quinolones-fluoroquinolones-23-speakers-11-eu-countries-share-experience" }, { "title": "Towards improved safety monitoring of veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/06/2018", "last_updated_date": "06/06/2018", "news_url": "https://www.ema.europa.eu/en/news/towards-improved-safety-monitoring-veterinary-medicines" }, { "title": "Two more EU Member States benefit from EU-US mutual recognition agreement for inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "01/06/2018", "last_updated_date": "01/06/2018", "news_url": "https://www.ema.europa.eu/en/news/two-more-eu-member-states-benefit-eu-us-mutual-recognition-agreement-inspections" }, { "title": "First monoclonal antibody therapy for prevention of migraine", "press_release": "Yes", "related_medicine_referral": "Aimovig", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/06/2018", "last_updated_date": "01/06/2018", "news_url": "https://www.ema.europa.eu/en/news/first-monoclonal-antibody-therapy-prevention-migraine" }, { "title": "New medicine for hereditary rare disease", "press_release": "Yes", "related_medicine_referral": "Tegsedi", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/06/2018", "last_updated_date": "01/06/2018", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-hereditary-rare-disease-0" }, { "title": "Esmya: new measures to minimise risk of rare but serious liver injury", "press_release": "Yes", "related_medicine_referral": "Esmya;Esmya", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/06/2018", "last_updated_date": "01/06/2018", "news_url": "https://www.ema.europa.eu/en/news/esmya-new-measures-minimise-risk-rare-serious-liver-injury" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018", "press_release": "No", "related_medicine_referral": "Aimovig;Alsitek;Tecentriq;Keytruda;Translarna;Briviact (in Italy: Nubriveo);Xeljanz;Restaysis;Exondys;Trazimera;Hyrimoz;Hefiya;Halimatoz;Nityr;Tegsedi;Rxulti;Myalepta;Esmya;Metamizole containing medicinal products;Scandonest and associated names", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/06/2018", "last_updated_date": "01/06/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-28-31-may-2018" }, { "title": "EMA restricts use of Keytruda and Tecentriq in bladder cancer", "press_release": "Yes", "related_medicine_referral": "Keytruda;Tecentriq", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/06/2018", "last_updated_date": "01/06/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-restricts-use-keytruda-tecentriq-bladder-cancer" }, { "title": "Construction of new EMA building in Amsterdam on track", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/05/2018", "last_updated_date": "29/05/2018", "news_url": "https://www.ema.europa.eu/en/news/construction-new-ema-building-amsterdam-track" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018", "press_release": "Yes", "related_medicine_referral": "Porcilis PCV M Hyo;Reconcile;Apoquel;Exzolt;Clynav;Ubac;Pexion", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "28/05/2018", "last_updated_date": "28/05/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-23-25-may-2018" }, { "title": "Development of antibiotics for children - towards a global approach", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "24/05/2018", "last_updated_date": "24/05/2018", "news_url": "https://www.ema.europa.eu/en/news/development-antibiotics-children-towards-global-approach" }, { "title": "Working together for people with rare and complex diseases", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/05/2018", "last_updated_date": "22/05/2018", "news_url": "https://www.ema.europa.eu/en/news/working-together-people-rare-complex-diseases" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018", "press_release": "No", "related_medicine_referral": "Esmya;Zinbryta;Hydroxyethyl starch (HES) containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "18/05/2018", "last_updated_date": "18/05/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-14-17-may-2018" }, { "title": "PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids", "press_release": "Yes", "related_medicine_referral": "Esmya;Esmya", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "18/05/2018", "last_updated_date": "18/05/2018", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-new-measures-minimise-risk-rare-serious-liver-injury-esmya-fibroids" }, { "title": "EMA review of Zinbryta confirms medicine's risks outweigh its benefits", "press_release": "Yes", "related_medicine_referral": "Zinbryta;Zinbryta", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "18/05/2018", "last_updated_date": "18/05/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits" }, { "title": "New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir", "press_release": "Yes", "related_medicine_referral": "Tivicay;Juluca;Triumeq", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "18/05/2018", "last_updated_date": "18/05/2018", "news_url": "https://www.ema.europa.eu/en/news/new-study-suggests-risk-birth-defects-babies-born-women-hiv-medicine-dolutegravir" }, { "title": "European Medicines Agency closed 21 May 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "18/05/2018", "last_updated_date": "18/05/2018", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-21-may-2018" }, { "title": "Two years of PRIME", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "07/05/2018", "last_updated_date": "07/05/2018", "news_url": "https://www.ema.europa.eu/en/news/two-years-prime" }, { "title": "European Medicines Agency closed 9-11 May 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/05/2018", "last_updated_date": "07/05/2018", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-9-11-may-2018" }, { "title": "EMA 2017 annual report published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/05/2018", "last_updated_date": "02/05/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-2017-annual-report-published" }, { "title": "Update of EU recommendations for 2018/2019 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/04/2018", "last_updated_date": "30/04/2018", "news_url": "https://www.ema.europa.eu/en/news/update-eu-recommendations-2018-2019-seasonal-flu-vaccine-composition" }, { "title": "Civil society representatives wanted for EMA's Management Board and Pharmacovigilance Committee", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "30/04/2018", "last_updated_date": "30/04/2018", "news_url": "https://www.ema.europa.eu/en/news/civil-society-representatives-wanted-emas-management-board-pharmacovigilance-committee" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2018", "press_release": "No", "related_medicine_referral": "Biktarvy;Dzuveo;Qtern;Prohippur;Eladynos;Dexxience;Alsitek;Yervoy;Xultophy;Xeljanz;Sprycel;Prolia;Perjeta;Cimzia;Carmustine medac (previously Carmustine Obvius)", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/04/2018", "last_updated_date": "27/04/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-april-2018" }, { "title": "European Medicines Agency closed 1 May 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "27/04/2018", "last_updated_date": "27/04/2018", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-may-2018" }, { "title": "Updated rules for clinical development of vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/04/2018", "last_updated_date": "26/04/2018", "news_url": "https://www.ema.europa.eu/en/news/updated-rules-clinical-development-vaccines" }, { "title": "Ten years promoting high-quality scientific research in paediatric medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/04/2018", "last_updated_date": "25/04/2018", "news_url": "https://www.ema.europa.eu/en/news/ten-years-promoting-high-quality-scientific-research-paediatric-medicines" }, { "title": "The European Medicines Agency and the Netherlands agree on Seat Agreement", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "24/04/2018", "last_updated_date": "24/04/2018", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-netherlands-agree-seat-agreement" }, { "title": "European Immunization Week 2018: Statement of Guido Rasi, Executive Director, European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "23/04/2018", "last_updated_date": "23/04/2018", "news_url": "https://www.ema.europa.eu/en/news/european-immunization-week-2018-statement-guido-rasi-executive-director-european-medicines-agency" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-19 April 2018", "press_release": "Yes", "related_medicine_referral": "Dany's BienenWohl;Credelio;Vaxxitek HVT+IBD;Aftovaxpur DOE;Purevax RCPCh FeLV;Purevax RCPCh;Purevax RCP FeLV;Purevax RCP;Purevax RC;Purevax Rabies;Purevax FeLV;ProteqFlu-Te;Proteq West Nile;ProteqFlu;Parvoduk;Oncept IL-2;Vectormune ND;Porcilis ColiClos", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/04/2018", "last_updated_date": "20/04/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-17-19-april-2018" }, { "title": "Eye injuries in people and dogs when using Osurnia ear gel for dogs", "press_release": "Yes", "related_medicine_referral": "Osurnia", "categories": "Human;Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/04/2018", "last_updated_date": "20/04/2018", "news_url": "https://www.ema.europa.eu/en/news/eye-injuries-people-dogs-when-using-osurnia-ear-gel-dogs" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 April 2018", "press_release": "No", "related_medicine_referral": "Methotrexate containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/04/2018", "last_updated_date": "13/04/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-april-2018" }, { "title": "EMA reviewing risk of dosing errors with methotrexate", "press_release": "Yes", "related_medicine_referral": "Methotrexate containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "13/04/2018", "last_updated_date": "13/04/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-reviewing-risk-dosing-errors-methotrexate" }, { "title": "Increasing oversight of API manufacturing through international collaboration", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/04/2018", "last_updated_date": "12/04/2018", "news_url": "https://www.ema.europa.eu/en/news/increasing-oversight-api-manufacturing-through-international-collaboration" }, { "title": "Redistribution of UK's portfolio of centrally authorised products", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/04/2018", "last_updated_date": "11/04/2018", "news_url": "https://www.ema.europa.eu/en/news/redistribution-uks-portfolio-centrally-authorised-products" }, { "title": "Public hearing on 13 June 2018", "press_release": "Yes", "related_medicine_referral": "Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/04/2018", "last_updated_date": "09/04/2018", "news_url": "https://www.ema.europa.eu/en/news/public-hearing-13-june-2018" }, { "title": "Regulatory information – 1.7% increase of fees from 1 April 2018", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/03/2018", "last_updated_date": "28/03/2018", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-17-increase-fees-1-april-2018" }, { "title": "European Medicines Agency closed 29 March to 2 April 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "27/03/2018", "last_updated_date": "27/03/2018", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-29-march-2-april-2018" }, { "title": "EU recommendations for 2018/2019 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/03/2018", "last_updated_date": "26/03/2018", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2018-2019-seasonal-flu-vaccine-composition" }, { "title": "Updated measures for pregnancy prevention during retinoid use", "press_release": "Yes", "related_medicine_referral": "Retinoid-containing medicinal products", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/03/2018", "last_updated_date": "23/03/2018", "news_url": "https://www.ema.europa.eu/en/news/updated-measures-pregnancy-prevention-during-retinoid-use" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018", "press_release": "No", "related_medicine_referral": "Juluca;Rubraca;Fiasp;Aranesp;Sutent;Repatha;Ivemend;Cabometyx;Nerlynx;Eladynos;Dexxience;Zessly;Kanjinti;Pemetrexed Krka;Prasugrel Viatris (previously Prasugrel Mylan);Retinoid-containing medicinal products;Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/03/2018", "last_updated_date": "23/03/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-march-2018" }, { "title": "New measures to avoid valproate exposure in pregnancy endorsed", "press_release": "Yes", "related_medicine_referral": "Valproate and related substances", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/03/2018", "last_updated_date": "23/03/2018", "news_url": "https://www.ema.europa.eu/en/news/new-measures-avoid-valproate-exposure-pregnancy-endorsed" }, { "title": "Colour change for insulin injection Fiasp to avoid mix ups with Tresiba", "press_release": "Yes", "related_medicine_referral": "Fiasp", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/03/2018", "last_updated_date": "23/03/2018", "news_url": "https://www.ema.europa.eu/en/news/colour-change-insulin-injection-fiasp-avoid-mix-ups-tresiba" }, { "title": "Withdrawal of pain medicine flupirtine endorsed", "press_release": "Yes", "related_medicine_referral": "Flupirtine-containing medicinal products", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/03/2018", "last_updated_date": "23/03/2018", "news_url": "https://www.ema.europa.eu/en/news/withdrawal-pain-medicine-flupirtine-endorsed" }, { "title": "Increased reporting of side effects of veterinary medicines helps to protect animal and human health", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/03/2018", "last_updated_date": "22/03/2018", "news_url": "https://www.ema.europa.eu/en/news/increased-reporting-side-effects-veterinary-medicines-helps-protect-animal-human-health" }, { "title": "Workshop on Paediatric Regulation – stakeholders to discuss how to boost development of medicines for children", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "19/03/2018", "last_updated_date": "19/03/2018", "news_url": "https://www.ema.europa.eu/en/news/workshop-paediatric-regulation-stakeholders-discuss-how-boost-development-medicines-children" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 March 2018", "press_release": "Yes", "related_medicine_referral": "Rabigen SAG2;Naxcel;Bravecto Plus;Evalon;Cytopoint;Letifend;Vectormune ND;NexGard;Meloxidolor;Bravecto;Semintra;Activyl Tick Plus;Zolvix;Onsior;Naxcel", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/03/2018", "last_updated_date": "16/03/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-march-2018" }, { "title": "EMA Management Board: highlights of March 2018 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/03/2018", "last_updated_date": "16/03/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2018-meeting" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018", "press_release": "No", "related_medicine_referral": "Xofigo;Esmya;Zinbryta;Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "09/03/2018", "last_updated_date": "09/03/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-march-2018" }, { "title": "Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone", "press_release": "Yes", "related_medicine_referral": "Xofigo;Xofigo", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "09/03/2018", "last_updated_date": "09/03/2018", "news_url": "https://www.ema.europa.eu/en/news/prostate-cancer-medicine-xofigo-must-not-be-used-zytiga-prednisone-prednisolone" }, { "title": "EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta", "press_release": "Yes", "related_medicine_referral": "Zinbryta;Zinbryta", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "07/03/2018", "last_updated_date": "07/03/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-immediate-suspension-recall-multiple-sclerosis-medicine-zinbryta" }, { "title": "Regulatory information – adjusted fees for applications to EMA from 1 April 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/03/2018", "last_updated_date": "05/03/2018", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2018" }, { "title": "New tracking tool for EMA's relocation to Amsterdam", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/03/2018", "last_updated_date": "05/03/2018", "news_url": "https://www.ema.europa.eu/en/news/new-tracking-tool-emas-relocation-amsterdam" }, { "title": "EMA urgently reviewing multiple sclerosis medicine Zinbryta following cases of inflammatory brain disorders", "press_release": "Yes", "related_medicine_referral": "Zinbryta;Zinbryta", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "02/03/2018", "last_updated_date": "02/03/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-urgently-reviewing-multiple-sclerosis-medicine-zinbryta-following-cases-inflammatory-brain-disorders" }, { "title": "Four more EU Member States benefit from EU-US mutual recognition agreement for inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "01/03/2018", "last_updated_date": "01/03/2018", "news_url": "https://www.ema.europa.eu/en/news/four-more-eu-member-states-benefit-eu-us-mutual-recognition-agreement-inspections" }, { "title": "European Medicines Agency welcomes new Head of Veterinary Medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "01/03/2018", "last_updated_date": "01/03/2018", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-veterinary-medicines" }, { "title": "Management Board initiates building approval process for EMA premises in Amsterdam", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/02/2018", "last_updated_date": "28/02/2018", "news_url": "https://www.ema.europa.eu/en/news/management-board-initiates-building-approval-process-ema-premises-amsterdam" }, { "title": "Revised guideline on clinical studies for Alzheimer's disease medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "28/02/2018", "last_updated_date": "28/02/2018", "news_url": "https://www.ema.europa.eu/en/news/revised-guideline-clinical-studies-alzheimers-disease-medicines" }, { "title": "Towards more ethical use of animals in medicine testing", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/02/2018", "last_updated_date": "26/02/2018", "news_url": "https://www.ema.europa.eu/en/news/towards-more-ethical-use-animals-medicine-testing" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018", "press_release": "No", "related_medicine_referral": "Alpivab;Zydelig;Sutent;Xgeva;Lynparza;Kineret;Isentress;Feraccru;Bosulif;Nerlynx;Trydonis;Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.);Mylotarg;Amglidia", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/02/2018", "last_updated_date": "23/02/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-february-2018" }, { "title": "First medicine to treat neonatal diabetes", "press_release": "Yes", "related_medicine_referral": "Amglidia", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/02/2018", "last_updated_date": "23/02/2018", "news_url": "https://www.ema.europa.eu/en/news/first-medicine-treat-neonatal-diabetes" }, { "title": "New treatment option for rare inflammatory disease", "press_release": "Yes", "related_medicine_referral": "Kineret", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/02/2018", "last_updated_date": "23/02/2018", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-option-rare-inflammatory-disease" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018", "press_release": "Yes", "related_medicine_referral": "Clevor;Versican Plus Pi/L4R;Versican Plus Pi/L4;Versican Plus L4;ProteqFlu-Te;ProteqFlu;Fortekor Plus;Econor;Coliprotec F4;Bovela;Aivlosin;ProZinc;Porcilis PCV ID;Vaxxitek HVT+IBD;Ingelvac PCV FLEX;Ingelvac CircoFLEX;Vaxxitek HVT+IBD;Purevax RCPCh FeLV;Purevax RCP FeLV;Purevax RCP;Purevax RC;Purevax Rabies;Purevax FeLV;ProteqFlu-Te;Proteq West Nile;ProteqFlu;Parvoduk;Oncept IL-2;Eravac;Metacam;Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/02/2018", "last_updated_date": "16/02/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-february-2018" }, { "title": "Veterinary medicines: highlights of 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "13/02/2018", "last_updated_date": "13/02/2018", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2017" }, { "title": "Regulatory information – adjusted fees for pharmacovigilance applications to EMA from 12 February 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/02/2018", "last_updated_date": "12/02/2018", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-pharmacovigilance-applications-ema-12-february-2018" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2018", "press_release": "No", "related_medicine_referral": "Valproate and related substances;Esmya;Flupirtine-containing medicinal products;Retinoid-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "09/02/2018", "last_updated_date": "09/02/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-february-2018" }, { "title": "PRAC recommends new measures to avoid valproate exposure in pregnancy", "press_release": "Yes", "related_medicine_referral": "Valproate and related substances", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "09/02/2018", "last_updated_date": "09/02/2018", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-new-measures-avoid-valproate-exposure-pregnancy" }, { "title": "Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing", "press_release": "Yes", "related_medicine_referral": "Esmya;Esmya", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "09/02/2018", "last_updated_date": "09/02/2018", "news_url": "https://www.ema.europa.eu/en/news/women-taking-esmya-uterine-fibroids-have-regular-liver-tests-while-ema-review-ongoing" }, { "title": "Management Board started building approval process of EMA premises in Amsterdam", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/02/2018", "last_updated_date": "07/02/2018", "news_url": "https://www.ema.europa.eu/en/news/management-board-started-building-approval-process-ema-premises-amsterdam" }, { "title": "General Court confirms EMA approach to transparency", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/02/2018", "last_updated_date": "06/02/2018", "news_url": "https://www.ema.europa.eu/en/news/general-court-confirms-ema-approach-transparency" }, { "title": "Strengthened guidance on follow-up and risk management for ATMP developers", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "01/02/2018", "last_updated_date": "01/02/2018", "news_url": "https://www.ema.europa.eu/en/news/strengthened-guidance-follow-risk-management-atmp-developers" }, { "title": "Evaluation of advanced therapy medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "01/02/2018", "last_updated_date": "01/02/2018", "news_url": "https://www.ema.europa.eu/en/news/evaluation-advanced-therapy-medicines" }, { "title": "How to better apply the paediatric legislation to boost development of medicines for children", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "31/01/2018", "last_updated_date": "31/01/2018", "news_url": "https://www.ema.europa.eu/en/news/how-better-apply-paediatric-legislation-boost-development-medicines-children" }, { "title": "Statement by Executive Director Guido Rasi in The Hague", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/01/2018", "last_updated_date": "29/01/2018", "news_url": "https://www.ema.europa.eu/en/news/statement-executive-director-guido-rasi-hague" }, { "title": "Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation", "press_release": "Yes", "related_medicine_referral": "Hydroxyethyl starch (HES) containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "26/01/2018", "last_updated_date": "26/01/2018", "news_url": "https://www.ema.europa.eu/en/news/hydroxyethyl-starch-solutions-infusion-be-suspended-cmdh-endorses-prac-recommendation" }, { "title": "First-in-class medicine to prevent bleeding in haemophilia A patients with inhibitors", "press_release": "Yes", "related_medicine_referral": "Hemlibra", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/01/2018", "last_updated_date": "26/01/2018", "news_url": "https://www.ema.europa.eu/en/news/first-class-medicine-prevent-bleeding-haemophilia-patients-inhibitors" }, { "title": "New enzyme replacement therapy to treat rare genetic disorder alpha-mannosidosis in children and adults", "press_release": "Yes", "related_medicine_referral": "Lamzede", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "26/01/2018", "last_updated_date": "26/01/2018", "news_url": "https://www.ema.europa.eu/en/news/new-enzyme-replacement-therapy-treat-rare-genetic-disorder-alpha-mannosidosis-children-adults" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018", "press_release": "No", "related_medicine_referral": "Hemlibra;Lamzede;Raxone;Revinty Ellipta;Relvar Ellipta;Hizentra;Opdivo;Rotigotine Mylan;Balimek;EnCyzix;Lokelma;Semglee;Steglujan;Steglatro;Shingrix;Segluromet", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/01/2018", "last_updated_date": "26/01/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-january-2018" }, { "title": "EMA surveys pharma companies on their preparedness for Brexit", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "23/01/2018", "last_updated_date": "23/01/2018", "news_url": "https://www.ema.europa.eu/en/news/ema-surveys-pharma-companies-their-preparedness-brexit" }, { "title": "Why EMA matters to European citizens", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/01/2018", "last_updated_date": "23/01/2018", "news_url": "https://www.ema.europa.eu/en/news/why-ema-matters-european-citizens" }, { "title": "Human medicines: highlights of 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "23/01/2018", "last_updated_date": "23/01/2018", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2017" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 January 2018", "press_release": "Yes", "related_medicine_referral": "Panacur AquaSol;Vectra 3D;Stronghold Plus;Semintra;ProZinc;Porcilis PCV ID;Nexgard Spectra;Coliprotec F4/F18;Oncept IL-2;Equilis West Nile;Suvaxyn PCV;Meloxidyl;Vectormune ND;Advocate", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/01/2018", "last_updated_date": "19/01/2018", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-16-18-january-2018" }, { "title": "Is an orphan medicine still an orphan once it gets on the market?", "press_release": "No", "related_medicine_referral": "Prevymis", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "17/01/2018", "last_updated_date": "17/01/2018", "news_url": "https://www.ema.europa.eu/en/news/orphan-medicine-still-orphan-once-it-gets-market" }, { "title": "Defect with Buccolam oral syringes", "press_release": "Yes", "related_medicine_referral": "Buccolam", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/01/2018", "last_updated_date": "15/01/2018", "news_url": "https://www.ema.europa.eu/en/news/defect-buccolam-oral-syringes" }, { "title": "Chair of EMA's committee for orphan medicines receives award for outstanding patient engagement", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/01/2018", "last_updated_date": "15/01/2018", "news_url": "https://www.ema.europa.eu/en/news/chair-emas-committee-orphan-medicines-receives-award-outstanding-patient-engagement" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2018", "press_release": "No", "related_medicine_referral": "Flupirtine-containing medicinal products;Retinoid-containing medicinal products;Esmya;Xofigo;Hydroxyethyl starch (HES) containing medicinal products;Valproate and related substances;Quinolone- and fluoroquinolone-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/01/2018", "last_updated_date": "12/01/2018", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-january-2018" }, { "title": "PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market", "press_release": "Yes", "related_medicine_referral": "Hydroxyethyl starch solutions for infusion;Hydroxyethyl starch (HES) containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/01/2018", "last_updated_date": "12/01/2018", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-suspending-hydroxyethyl-starch-solutions-infusion-market" }, { "title": "Orphan medicines in the EU – leaving no-one behind", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Rare diseases", "news_summary": "", "first_published_date": "21/12/2017", "last_updated_date": "21/12/2017", "news_url": "https://www.ema.europa.eu/en/news/orphan-medicines-eu-leaving-no-one-behind" }, { "title": "End of year message from EMA's Executive Director", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/12/2017", "last_updated_date": "21/12/2017", "news_url": "https://www.ema.europa.eu/en/news/end-year-message-emas-executive-director" }, { "title": "European Medicines Agency closed 22 December 2017 to 2 January 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "20/12/2017", "last_updated_date": "20/12/2017", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-22-december-2017-2-january-2018" }, { "title": "Regulatory information – adjusted fees for pharmacovigilance applications to EMA from January 2018", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/12/2017", "last_updated_date": "20/12/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-pharmacovigilance-applications-ema-january-2018" }, { "title": "Modified-release paracetamol-containing products to be suspended from EU market", "press_release": "Yes", "related_medicine_referral": "Paracetamol modified-release", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/12/2017", "last_updated_date": "15/12/2017", "news_url": "https://www.ema.europa.eu/en/news/modified-release-paracetamol-containing-products-be-suspended-eu-market" }, { "title": "European Commission closes infringement procedure against Roche", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/12/2017", "last_updated_date": "15/12/2017", "news_url": "https://www.ema.europa.eu/en/news/european-commission-closes-infringement-procedure-against-roche" }, { "title": "New medicine to treat perianal fistulas in patients with Crohn's disease", "press_release": "Yes", "related_medicine_referral": "Alofisel", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/12/2017", "last_updated_date": "15/12/2017", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-treat-perianal-fistulas-patients-crohns-disease" }, { "title": "First paediatric medicine to treat rare hormonal disorder", "press_release": "Yes", "related_medicine_referral": "Alkindi", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/12/2017", "last_updated_date": "15/12/2017", "news_url": "https://www.ema.europa.eu/en/news/first-paediatric-medicine-treat-rare-hormonal-disorder" }, { "title": "New medicine for rare bone disease", "press_release": "Yes", "related_medicine_referral": "Crysvita", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/12/2017", "last_updated_date": "15/12/2017", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-rare-bone-disease" }, { "title": "Mycophenolate: updated recommendations for contraception for men and women", "press_release": "Yes", "related_medicine_referral": "CellCept;Myfenax;Mycophenolate mofetil Teva;Myclausen", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/12/2017", "last_updated_date": "15/12/2017", "news_url": "https://www.ema.europa.eu/en/news/mycophenolate-updated-recommendations-contraception-men-women" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2017", "press_release": "No", "related_medicine_referral": "Alkindi;Alofisel;Efavirenz/Emtricitabine/Tenofovir disoproxil Krka;Truvada;Yervoy;Taltz;Qizenday;Anagrelide Viatris (previously Anagrelide Mylan);Herzuma;Ozempic;Crysvita", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/12/2017", "last_updated_date": "15/12/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-december-2017" }, { "title": "EMA Management Board: highlights of December 2017 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/12/2017", "last_updated_date": "15/12/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2017-meeting" }, { "title": "First guidance on monoclonal antibodies for use in animals", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/12/2017", "last_updated_date": "11/12/2017", "news_url": "https://www.ema.europa.eu/en/news/first-guidance-monoclonal-antibodies-use-animals" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 2017", "press_release": "Yes", "related_medicine_referral": "Suvaxyn Circo;Zactran;Nobivac L4;Canigen L4;Versican Plus Pi;Versican Plus DHPPi;Leucofeligen FeLV/RCP;UpCard;Suvaxyn PCV;Sileo;Sedadex;Respiporc Flu3;Pirsue;Osurnia;Meloxidyl;Innovax-ILT;Gripovac 3;Cortavance;Ecoporc Shiga;Respiporc FLUpan H1N1;Easotic", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/12/2017", "last_updated_date": "08/12/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-december-2017" }, { "title": "Call for patient organisation representatives to join the Committee for Orphan Medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "04/12/2017", "last_updated_date": "04/12/2017", "news_url": "https://www.ema.europa.eu/en/news/call-patient-organisation-representatives-join-committee-orphan-medicines" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017", "press_release": "No", "related_medicine_referral": "Xofigo;Esmya;Paracetamol modified-release;Xofigo;Esmya", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "01/12/2017", "last_updated_date": "01/12/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-november-2017" }, { "title": "Regulatory guidance for pharmaceutical companies to prepare for UK's withdrawal from EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/12/2017", "last_updated_date": "01/12/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-guidance-pharmaceutical-companies-prepare-uks-withdrawal-eu" }, { "title": "Procedural guidance to help pharma companies prepare for Brexit", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "28/11/2017", "last_updated_date": "28/11/2017", "news_url": "https://www.ema.europa.eu/en/news/procedural-guidance-help-pharma-companies-prepare-brexit" }, { "title": "ENCePP: 10 years for excellence in medicines safety", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/11/2017", "last_updated_date": "24/11/2017", "news_url": "https://www.ema.europa.eu/en/news/encepp-10-years-excellence-medicines-safety" }, { "title": "EU Ombudsman confirms EMA's correct handling of declared interests", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/11/2017", "last_updated_date": "24/11/2017", "news_url": "https://www.ema.europa.eu/en/news/eu-ombudsman-confirms-emas-correct-handling-declared-interests" }, { "title": "New guidelines on good manufacturing practices for advanced therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections;Regulatory and procedural guidance", "news_summary": "", "first_published_date": "24/11/2017", "last_updated_date": "24/11/2017", "news_url": "https://www.ema.europa.eu/en/news/new-guidelines-good-manufacturing-practices-advanced-therapies" }, { "title": "New EudraVigilance system is live", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/11/2017", "last_updated_date": "22/11/2017", "news_url": "https://www.ema.europa.eu/en/news/new-eudravigilance-system-live" }, { "title": "EMA to relocate to Amsterdam, the Netherlands", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/11/2017", "last_updated_date": "20/11/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-relocate-amsterdam-netherlands" }, { "title": "Towards a single development programme for new antibiotics in EU, Japan and US", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/11/2017", "last_updated_date": "17/11/2017", "news_url": "https://www.ema.europa.eu/en/news/towards-single-development-programme-new-antibiotics-eu-japan-us" }, { "title": "Improving the availability of vaccines for animals within the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/11/2017", "last_updated_date": "16/11/2017", "news_url": "https://www.ema.europa.eu/en/news/improving-availability-vaccines-animals-within-eu" }, { "title": "EMA to work with stakeholders to improve the product information for EU medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/11/2017", "last_updated_date": "15/11/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-work-stakeholders-improve-product-information-eu-medicines" }, { "title": "European Antibiotic Awareness Day: Statement by Guido Rasi, Executive Director of the European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "15/11/2017", "last_updated_date": "15/11/2017", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-statement-guido-rasi-executive-director-european-medicines-agency" }, { "title": "Regulatory update - EMA encourages companies to submit type I variations for 2017 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/11/2017", "last_updated_date": "14/11/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2017-end-november-0" }, { "title": "EMA and EUnetHTA finalise joint work plan for 2017-2020", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/11/2017", "last_updated_date": "13/11/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-eunethta-finalise-joint-work-plan-2017-2020" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7–9 November 2017", "press_release": "Yes", "related_medicine_referral": "Eravac;Exzolt;Galliprant;Semintra;Vectormune ND", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/11/2017", "last_updated_date": "10/11/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-november-2017" }, { "title": "New medicine for rare inflammatory condition of the oesophagus", "press_release": "Yes", "related_medicine_referral": "Jorveza", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "10/11/2017", "last_updated_date": "10/11/2017", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-rare-inflammatory-condition-oesophagus" }, { "title": "New medicine to prevent cytomegalovirus disease in stem cell transplant patients", "press_release": "Yes", "related_medicine_referral": "Prevymis", "categories": "Human", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "10/11/2017", "last_updated_date": "10/11/2017", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-prevent-cytomegalovirus-disease-stem-cell-transplant-patients" }, { "title": "New medicine for multiple sclerosis", "press_release": "Yes", "related_medicine_referral": "Ocrevus", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "10/11/2017", "last_updated_date": "10/11/2017", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-multiple-sclerosis" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017", "press_release": "No", "related_medicine_referral": "Fasenra;Intrarosa;Adynovi;Nplate;Genvoya;Adcetris;Orkambi;Keytruda;Plivensia;Kyomarc;Onzeald;Fanaptum;Fulvestrant Mylan;Darunavir Krka d.d.;Darunavir Krka;Ocrevus;Mvasi;Prevymis;Jorveza;Zinbryta", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "10/11/2017", "last_updated_date": "10/11/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-6-9-november-2017" }, { "title": "EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage", "press_release": "Yes", "related_medicine_referral": "Zinbryta;Zinbryta", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "10/11/2017", "last_updated_date": "10/11/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-concludes-review-zinbryta-confirms-further-restrictions-reduce-risk-liver-damage" }, { "title": "EMA gets ready for relocation decision", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/11/2017", "last_updated_date": "07/11/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-gets-ready-relocation-decision" }, { "title": "EU-US mutual recognition of inspections of medicines manufacturers enters operational phase", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "31/10/2017", "last_updated_date": "31/10/2017", "news_url": "https://www.ema.europa.eu/en/news/eu-us-mutual-recognition-inspections-medicines-manufacturers-enters-operational-phase" }, { "title": "How to develop vaccines and medicines that prevent and treat respiratory syncytial virus (RSV) infection", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/10/2017", "last_updated_date": "30/10/2017", "news_url": "https://www.ema.europa.eu/en/news/how-develop-vaccines-medicines-prevent-treat-respiratory-syncytial-virus-rsv-infection" }, { "title": "European Medicines Agency closed 1-3 November 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "30/10/2017", "last_updated_date": "30/10/2017", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-3-november-2017" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2017", "press_release": "No", "related_medicine_referral": "Zinbryta;Hydroxyethyl starch (HES) containing medicinal products;Zinbryta;Flupirtine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "27/10/2017", "last_updated_date": "27/10/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-23-26-october-2017" }, { "title": "EMA starts new review of hydroxyethyl-starch containing medicines", "press_release": "Yes", "related_medicine_referral": "Hydroxyethyl starch (HES) containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "27/10/2017", "last_updated_date": "27/10/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-starts-new-review-hydroxyethyl-starch-containing-medicines" }, { "title": "Review of flupirtine-containing medicines started", "press_release": "Yes", "related_medicine_referral": "Flupirtine-containing medicinal products", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "27/10/2017", "last_updated_date": "27/10/2017", "news_url": "https://www.ema.europa.eu/en/news/review-flupirtine-containing-medicines-started" }, { "title": "PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage", "press_release": "Yes", "related_medicine_referral": "Zinbryta;Zinbryta", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "27/10/2017", "last_updated_date": "27/10/2017", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-further-restrictions-multiple-sclerosis-medicine-zinbryta-due-risk-serious-liver-damage" }, { "title": "EMA website briefly unavailable on 27 October", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/10/2017", "last_updated_date": "26/10/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-27-october" }, { "title": "EU scientific opinion: how to assess progress on reduction of antimicrobial resistance and antimicrobial consumption", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/10/2017", "last_updated_date": "26/10/2017", "news_url": "https://www.ema.europa.eu/en/news/eu-scientific-opinion-how-assess-progress-reduction-antimicrobial-resistance-antimicrobial-consumption" }, { "title": "Unparalleled access to clinical data - one year on", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/10/2017", "last_updated_date": "20/10/2017", "news_url": "https://www.ema.europa.eu/en/news/unparalleled-access-clinical-data-one-year" }, { "title": "New action plan to foster development of advanced therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "20/10/2017", "last_updated_date": "20/10/2017", "news_url": "https://www.ema.europa.eu/en/news/new-action-plan-foster-development-advanced-therapies" }, { "title": "Data privacy in the age of big data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/10/2017", "last_updated_date": "19/10/2017", "news_url": "https://www.ema.europa.eu/en/news/data-privacy-age-big-data" }, { "title": "EMA's procedural handling of safety review was complete and independent", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/10/2017", "last_updated_date": "17/10/2017", "news_url": "https://www.ema.europa.eu/en/news/emas-procedural-handling-safety-review-was-complete-independent" }, { "title": "EMA's Business Continuity Plan for Brexit published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "16/10/2017", "last_updated_date": "16/10/2017", "news_url": "https://www.ema.europa.eu/en/news/emas-business-continuity-plan-brexit-published" }, { "title": "Sales of antibiotics for animal use decrease by 13% in Europe between 2011 and 2015", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/10/2017", "last_updated_date": "16/10/2017", "news_url": "https://www.ema.europa.eu/en/news/sales-antibiotics-animal-use-decrease-13-europe-between-2011-2015" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2017", "press_release": "No", "related_medicine_referral": "Alecensa;Bydureon;Tacforius;Raxone;Zytiga;Pegasys;Faslodex;Cubicin;Alcover and associated names", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "13/10/2017", "last_updated_date": "13/10/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-9-12-october-2017" }, { "title": "Better labelling of excipients for safe use of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Product information", "news_summary": "", "first_published_date": "09/10/2017", "last_updated_date": "09/10/2017", "news_url": "https://www.ema.europa.eu/en/news/better-labelling-excipients-safe-use-medicines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3–5 October 2017", "press_release": "Yes", "related_medicine_referral": "SevoFlo;Hiprabovis IBR Marker Live;Rabitec;MiPet Easecto;Pexion;Kexxtone;Porcilis PCV M Hyo;Imrestor", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "06/10/2017", "last_updated_date": "06/10/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-3-5-october-2017" }, { "title": "EMA Management Board: highlights of October 2017 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/10/2017", "last_updated_date": "06/10/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2017-meeting" }, { "title": "Regulatory update - EMA encourages companies to submit type I variations for 2017 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/10/2017", "last_updated_date": "05/10/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2017-end-november" }, { "title": "EMA takes yet another step in public engagement with its first public hearing", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/10/2017", "last_updated_date": "05/10/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-takes-yet-another-step-public-engagement-its-first-public-hearing" }, { "title": "Countdown to launch of new EudraVigilance System", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/10/2017", "last_updated_date": "04/10/2017", "news_url": "https://www.ema.europa.eu/en/news/countdown-launch-new-eudravigilance-system" }, { "title": "EMA publishes comments on Member States' hosting bids", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/10/2017", "last_updated_date": "03/10/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-publishes-comments-member-states-hosting-bids" }, { "title": "General Court finds no fault in 2011 appointment procedure of EMA Executive Director", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/10/2017", "last_updated_date": "03/10/2017", "news_url": "https://www.ema.europa.eu/en/news/general-court-finds-no-fault-2011-appointment-procedure-ema-executive-director" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-29 September 2017", "press_release": "No", "related_medicine_referral": "Valproate and related substances;Paracetamol modified-release", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "29/09/2017", "last_updated_date": "29/09/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-29-september-2017" }, { "title": "Exploring opportunities for collaboration between regulators and healthcare payers", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/09/2017", "last_updated_date": "27/09/2017", "news_url": "https://www.ema.europa.eu/en/news/exploring-opportunities-collaboration-between-regulators-healthcare-payers" }, { "title": "Update on EMA relocation preparedness", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/09/2017", "last_updated_date": "26/09/2017", "news_url": "https://www.ema.europa.eu/en/news/update-ema-relocation-preparedness" }, { "title": "EMA's first public hearing: giving EU citizens a voice to help reduce the risk of valproate", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/09/2017", "last_updated_date": "26/09/2017", "news_url": "https://www.ema.europa.eu/en/news/emas-first-public-hearing-giving-eu-citizens-voice-help-reduce-risk-valproate" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017", "press_release": "No", "related_medicine_referral": "Elebrato Ellipta;Tremfya;Opdivo;Tigecycline Accord;Ogivri;Fulphila;Raxone;Stribild;Firazyr;Tasigna;Benlysta;Masipro;Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech;Adlumiz;Ontruzant;Cyltezo;Ritonavir Viatris (previously Ritonavir Mylan);Miglustat Gen.Orph;Imatinib Teva B.V.;Zubsolv;Zejula;VeraSeal;Trelegy Ellipta;Tookad;Nyxoid;Factor VIII;Scandonest and associated names", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/09/2017", "last_updated_date": "15/09/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-september-2017" }, { "title": "Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes", "press_release": "Yes", "related_medicine_referral": "Voncento;Obizur;Advate;Elocta;ReFacto AF;Kovaltry;NovoEight;Nuwiq;Kogenate Bayer;Iblias;Helixate NexGen;Factor VIII", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/09/2017", "last_updated_date": "15/09/2017", "news_url": "https://www.ema.europa.eu/en/news/factor-viii-medicines-no-clear-consistent-evidence-difference-risk-inhibitor-development-between-classes" }, { "title": "Raising awareness of the perils of antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/09/2017", "last_updated_date": "12/09/2017", "news_url": "https://www.ema.europa.eu/en/news/raising-awareness-perils-antimicrobial-resistance" }, { "title": "How the EU regulates medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/09/2017", "last_updated_date": "11/09/2017", "news_url": "https://www.ema.europa.eu/en/news/how-eu-regulates-medicines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 September 2017", "press_release": "Yes", "related_medicine_referral": "Nobivac LeuFel;Purevax RCP;Purevax RC;Purevax RCP FeLV;Bovalto Ibraxion;Purevax RCPCh;Eurican Herpes 205;Rhiniseng;Respiporc Flu3;Reconcile;Nexgard Spectra;Simparica;Oxybee;Bovilis Blue-8;Versican Plus DHPPi;Bovela;Zolvix;Recuvyra;Meloxidolor;Letifend;Eravac;Contacera;Fevaxyn Pentofel;Purevax RCPCh FeLV;Parvoduk;BTVPUR;BTVPUR AlSap 2-4", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/09/2017", "last_updated_date": "08/09/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-september-2017" }, { "title": "Reporting side effects of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/09/2017", "last_updated_date": "04/09/2017", "news_url": "https://www.ema.europa.eu/en/news/reporting-side-effects-medicines" }, { "title": "Facilitating submission of post-approval data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/09/2017", "last_updated_date": "01/09/2017", "news_url": "https://www.ema.europa.eu/en/news/facilitating-submission-post-approval-data" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August-1 September 2017", "press_release": "No", "related_medicine_referral": "Factor VIII;Paracetamol modified-release", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "01/09/2017", "last_updated_date": "01/09/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-august-1-september-2017" }, { "title": "Strengthening EU-US cooperation in medicine inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "23/08/2017", "last_updated_date": "23/08/2017", "news_url": "https://www.ema.europa.eu/en/news/strengthening-eu-us-cooperation-medicine-inspections" }, { "title": "Better veterinary medicines for healthier animals and people", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/08/2017", "last_updated_date": "21/08/2017", "news_url": "https://www.ema.europa.eu/en/news/better-veterinary-medicines-healthier-animals-people" }, { "title": "Tick and flea control agent Bravecto continues to be acceptably safe to use", "press_release": "No", "related_medicine_referral": "Bravecto", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/08/2017", "last_updated_date": "17/08/2017", "news_url": "https://www.ema.europa.eu/en/news/tick-flea-control-agent-bravecto-continues-be-acceptably-safe-use" }, { "title": "Science and innovation for better medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/08/2017", "last_updated_date": "10/08/2017", "news_url": "https://www.ema.europa.eu/en/news/science-innovation-better-medicines" }, { "title": "EMA supports regulatory harmonisation in East Africa", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/08/2017", "last_updated_date": "08/08/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-supports-regulatory-harmonisation-east-africa" }, { "title": "Platform for post-authorisation studies registered as EU trade mark", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/08/2017", "last_updated_date": "07/08/2017", "news_url": "https://www.ema.europa.eu/en/news/platform-post-authorisation-studies-registered-eu-trade-mark" }, { "title": "EMA prepares for Brexit", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "01/08/2017", "last_updated_date": "01/08/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-prepares-brexit" }, { "title": "CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins", "press_release": "Yes", "related_medicine_referral": "Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/08/2017", "last_updated_date": "01/08/2017", "news_url": "https://www.ema.europa.eu/en/news/cmdh-confirms-methylprednisolone-injections-containing-lactose-must-not-be-given-patients-allergic-cows-milk-proteins" }, { "title": "EMA encourages tailored development of medicines for older people", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/08/2017", "last_updated_date": "01/08/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-encourages-tailored-development-medicines-older-people" }, { "title": "Concept paper on development and lifecycle of personalised medicines and companion diagnostics", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/07/2017", "last_updated_date": "28/07/2017", "news_url": "https://www.ema.europa.eu/en/news/concept-paper-development-lifecycle-personalised-medicines-companion-diagnostics" }, { "title": "EU report: more evidence on link between antibiotic use and antibiotic resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "27/07/2017", "last_updated_date": "27/07/2017", "news_url": "https://www.ema.europa.eu/en/news/eu-report-more-evidence-link-between-antibiotic-use-antibiotic-resistance" }, { "title": "Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "news_url": "https://www.ema.europa.eu/en/news/reducing-label-use-antimicrobials-veterinary-medicine-reduce-risk-resistance" }, { "title": "Recommendations for use of aminoglycosides in animals to reduce risk of antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "news_url": "https://www.ema.europa.eu/en/news/recommendations-use-aminoglycosides-animals-reduce-risk-antimicrobial-resistance" }, { "title": "Revised guideline on first-in-human clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "25/07/2017", "last_updated_date": "25/07/2017", "news_url": "https://www.ema.europa.eu/en/news/revised-guideline-first-human-clinical-trials" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017", "press_release": "No", "related_medicine_referral": "Rydapt;Bavencio;Lacosamide Accord;Infinia;Vimpat;Sovaldi;Signifor;RoActemra;Rapamune;Keytruda;Humira;Gazyvaro;Bydureon;Onzeald;Fanaptum;Entecavir Viatris (previously Entecavir Mylan);Entecavir Accord;Xermelo;Verkazia;Tecentriq;Symtuza;Lutathera;Dupixent;Alcover and associated names;Gadolinium-containing contrast agents", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/07/2017", "last_updated_date": "21/07/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-july-2017" }, { "title": "New medicine for rare form of eye allergy in children and teenagers", "press_release": "Yes", "related_medicine_referral": "Verkazia", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "21/07/2017", "last_updated_date": "21/07/2017", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-rare-form-eye-allergy-children-teenagers" }, { "title": "EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans", "press_release": "Yes", "related_medicine_referral": "Gadolinium-containing contrast agents;Optimark", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/07/2017", "last_updated_date": "21/07/2017", "news_url": "https://www.ema.europa.eu/en/news/emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans" }, { "title": "Involving young people in EMA activities", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/07/2017", "last_updated_date": "19/07/2017", "news_url": "https://www.ema.europa.eu/en/news/involving-young-people-ema-activities" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 July 2017", "press_release": "Yes", "related_medicine_referral": "Zulvac 8 Bovis;Zulvac 8 Ovis;Nobilis IB 4-91;Equilis StrepE;Masivet;Osurnia;Vectormune ND;Zulvac SBV;Bravecto;Nobilis IB Primo QX;Equisolon;Activyl Tick Plus;Zulvac 1+8 Bovis;Zulvac 1 Ovis;Zulvac 1 Bovis;Zulvac 1+8 Ovis", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/07/2017", "last_updated_date": "14/07/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-july-2017" }, { "title": "Regulatory information – EMA improves its guidance for post-authorisation activities", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/07/2017", "last_updated_date": "14/07/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-improves-its-guidance-post-authorisation-activities" }, { "title": "Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment Committee (PRAC)", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "13/07/2017", "last_updated_date": "13/07/2017", "news_url": "https://www.ema.europa.eu/en/news/call-independent-scientific-experts-join-emas-pharmacovigilance-risk-assessment-committee-prac" }, { "title": "EMA seeks views of public during its safety review of valproate", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/07/2017", "last_updated_date": "11/07/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-seeks-views-public-during-its-safety-review-valproate" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 July 2017", "press_release": "No", "related_medicine_referral": "Zinbryta;Zinbryta;Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions;Valproate and related substances;Gadolinium-containing contrast agents", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/07/2017", "last_updated_date": "07/07/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-july-2017" }, { "title": "EMA restricts use of multiple sclerosis medicine Zinbryta", "press_release": "Yes", "related_medicine_referral": "Zinbryta;Zinbryta", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "07/07/2017", "last_updated_date": "07/07/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-restricts-use-multiple-sclerosis-medicine-zinbryta" }, { "title": "EMA and EUnetHTA step up interaction to align data requirements", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/07/2017", "last_updated_date": "04/07/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-eunethta-step-interaction-align-data-requirements" }, { "title": "EMA and FDA encourage use of innovative approaches in the development of medicines for Gaucher disease", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Innovation", "news_summary": "", "first_published_date": "03/07/2017", "last_updated_date": "03/07/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-fda-encourage-use-innovative-approaches-development-medicines-gaucher-disease" }, { "title": "First ever guidance for stem cell therapies in animals published", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "23/06/2017", "last_updated_date": "23/06/2017", "news_url": "https://www.ema.europa.eu/en/news/first-ever-guidance-stem-cell-therapies-animals-published" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017", "press_release": "No", "related_medicine_referral": "Orencia;Mavenclad;Harvoni;Soliris;Fotivda;Imraldi;Nitisinone MDK (previously Nitisinone MendeliKABS);Zafiride;Faslodex;Elmisol;Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan;SonoVue;Victoza;Vosevi;Kaletra;Kisqali;Masipro;Stivarga;Mimpara;Adlumiz;Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech;Maviret;Symbioflor 2;Alcover and associated names", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/06/2017", "last_updated_date": "23/06/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-june-2017" }, { "title": "Two new medicines recommended for the treatment of chronic hepatitis C", "press_release": "Yes", "related_medicine_referral": "Maviret;Vosevi", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/06/2017", "last_updated_date": "23/06/2017", "news_url": "https://www.ema.europa.eu/en/news/two-new-medicines-recommended-treatment-chronic-hepatitis-c-0" }, { "title": "EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/06/2017", "last_updated_date": "23/06/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-symbioflor-2-can-continue-be-used-irritable-bowel-syndrome" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 June 2017", "press_release": "Yes", "related_medicine_referral": "Vepured;Zactran;Versican Plus Pi/L4R;Versican Plus Pi/L4;Versican Plus Pi;Versican Plus L4;Sedadex;Porcilis PCV ID;Novaquin;Nobivac L4;Nobilis Influenza H5N2;Nexgard Spectra;Melovem;Canigen L4;Purevax Rabies;ProteqFlu-Te;Proteq West Nile;Oncept IL-2;Purevax RCPCh FeLV;Purevax RCP FeLV;Purevax FeLV;ProteqFlu;Pexion;Porcilis PCV;Suvaxyn Circo+MH RTU;Suvaxyn PRRS MLV;Exzolt;Innovax-ND-IBD", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/06/2017", "last_updated_date": "16/06/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-june-2017" }, { "title": "EMA Management Board: highlights of June 2017 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/06/2017", "last_updated_date": "16/06/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2017-meeting" }, { "title": "Regulators in EU, Japan and US take steps to facilitate development of new antibiotics", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/06/2017", "last_updated_date": "12/06/2017", "news_url": "https://www.ema.europa.eu/en/news/regulators-eu-japan-us-take-steps-facilitate-development-new-antibiotics" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2017", "press_release": "No", "related_medicine_referral": "Factor VIII;Zinbryta;Valproate and related substances", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "09/06/2017", "last_updated_date": "09/06/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-june-2017" }, { "title": "PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel", "press_release": "Yes", "related_medicine_referral": "Taxotere;Docetaxel Zentiva (previously Docetaxel Winthrop);Docetaxel Teva;Docetaxel Kabi;Docetaxel Accord;Taxespira (previously Docetaxel Hospira UK Limited )", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "09/06/2017", "last_updated_date": "09/06/2017", "news_url": "https://www.ema.europa.eu/en/news/prac-concludes-there-no-evidence-change-known-risk-neutropenic-enterocolitis-docetaxel" }, { "title": "Workshop: addressing unmet needs of children with pulmonary arterial hypertension", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "06/06/2017", "last_updated_date": "06/06/2017", "news_url": "https://www.ema.europa.eu/en/news/workshop-addressing-unmet-needs-children-pulmonary-arterial-hypertension" }, { "title": "European Medicines Agency closed 5 June 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/06/2017", "last_updated_date": "01/06/2017", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-5-june-2017" }, { "title": "New action plan to support SMEs as drivers of pharmaceutical innovation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "31/05/2017", "last_updated_date": "31/05/2017", "news_url": "https://www.ema.europa.eu/en/news/new-action-plan-support-smes-drivers-pharmaceutical-innovation" }, { "title": "Regulatory guidance for industry to prepare for the UK's withdrawal from the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "31/05/2017", "last_updated_date": "31/05/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-guidance-industry-prepare-uks-withdrawal-eu" }, { "title": "East African Community looks to EMA as model for future regional agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/05/2017", "last_updated_date": "23/05/2017", "news_url": "https://www.ema.europa.eu/en/news/east-african-community-looks-ema-model-future-regional-agency" }, { "title": "European Medicines Agency closed 25-26 May 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "23/05/2017", "last_updated_date": "23/05/2017", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-25-26-may-2017" }, { "title": "Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/05/2017", "last_updated_date": "22/05/2017", "news_url": "https://www.ema.europa.eu/en/news/green-light-given-new-eudravigilance-system-collection-monitoring-suspected-adverse-reactions" }, { "title": "EMA website briefly unavailable on 23 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/05/2017", "last_updated_date": "22/05/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-23-may" }, { "title": "New advanced therapy to repair cartilage defects in the knee", "press_release": "Yes", "related_medicine_referral": "Spherox", "categories": "Human", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "19/05/2017", "last_updated_date": "19/05/2017", "news_url": "https://www.ema.europa.eu/en/news/new-advanced-therapy-repair-cartilage-defects-knee" }, { "title": "New medicine for rare eye disease", "press_release": "Yes", "related_medicine_referral": "Oxervate", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/05/2017", "last_updated_date": "19/05/2017", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-rare-eye-disease" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 May 2017", "press_release": "No", "related_medicine_referral": "Insulin lispro Sanofi;Kyntheum;Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva);Renvela;Qinprezo;Uptravi;Zykadia;Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva);Isentress;Renvela;Onglyza;Komboglyze;Izba;Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech;Masipro;Adlumiz;Rituzena (previously Tuxella);Ritemvia;Blitzima;Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva;Spherox;Reagila;Trimbow;Veltassa;Oxervate;Vancomycin-containing medicines;Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets;Cardioxane", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/05/2017", "last_updated_date": "19/05/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-may-2017" }, { "title": "EMA recommends changes to prescribing information for vancomycin antibiotics", "press_release": "Yes", "related_medicine_referral": "Vancomycin-containing medicines", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/05/2017", "last_updated_date": "19/05/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-changes-prescribing-information-vancomycin-antibiotics" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 May 2017", "press_release": "Yes", "related_medicine_referral": "Vaxxitek HVT+IBD;Simparica;Velactis;UpCard;Trifexis;Sileo;Poulvac E. coli;Porcilis ColiClos;Zulvac 8 Ovis;Zulvac 8 Bovis;Onsior;Suvaxyn Aujeszky 783 + O/W;Innovax-ILT;Eryseng Parvo;Eryseng;Equilis Prequenza Te;Equilis Prequenza;Convenia;Cardalis;BTVPUR AlSap 1;BTVPUR;Broadline;Activyl;Nobivac Bb", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/05/2017", "last_updated_date": "15/05/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-may-2017" }, { "title": "Communication@EMA – how are we doing?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/05/2017", "last_updated_date": "10/05/2017", "news_url": "https://www.ema.europa.eu/en/news/communicationema-how-are-we-doing" }, { "title": "Progress on science, medicines and health", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/05/2017", "last_updated_date": "10/05/2017", "news_url": "https://www.ema.europa.eu/en/news/progress-science-medicines-health-0" }, { "title": "Involving patients in discussions on benefits and risks of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/05/2017", "last_updated_date": "08/05/2017", "news_url": "https://www.ema.europa.eu/en/news/involving-patients-discussions-benefits-risks-medicines" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2017", "press_release": "No", "related_medicine_referral": "Factor VIII", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "05/05/2017", "last_updated_date": "05/05/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-may-2017" }, { "title": "European Medicines Agency closed 9 May 2017", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "05/05/2017", "last_updated_date": "05/05/2017", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-9-may-2017" }, { "title": "New guide on biosimilar medicines for healthcare professionals", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Biosimilars", "news_summary": "", "first_published_date": "05/05/2017", "last_updated_date": "05/05/2017", "news_url": "https://www.ema.europa.eu/en/news/new-guide-biosimilar-medicines-healthcare-professionals" }, { "title": "EMA and heads of national competent authorities discuss consequences of Brexit", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Brexit", "news_summary": "", "first_published_date": "28/04/2017", "last_updated_date": "28/04/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-heads-national-competent-authorities-discuss-consequences-brexit" }, { "title": "European Medicines Agency closed 1 May 2017", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/04/2017", "last_updated_date": "27/04/2017", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-may-2017" }, { "title": "European Immunisation Week: Statement of Guido Rasi, the Executive Director of the European Medicines Agency (EMA)", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "25/04/2017", "last_updated_date": "25/04/2017", "news_url": "https://www.ema.europa.eu/en/news/european-immunisation-week-statement-guido-rasi-executive-director-european-medicines-agency-ema" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017", "press_release": "No", "related_medicine_referral": "Ucedane;Erelzi;Riximyo;Rixathon;Skilarence;Avastin;Besponsa;Celsentri;Febuxostat Viatris (previously Febuxostat Mylan);Spinraza;Solithromycin Triskel EU Services;Kevzara;Opdivo;Cuprior;Brineura;Etopophos;Vepesid", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-april-2017" }, { "title": "First medicine for spinal muscular atrophy", "press_release": "Yes", "related_medicine_referral": "Spinraza", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "news_url": "https://www.ema.europa.eu/en/news/first-medicine-spinal-muscular-atrophy" }, { "title": "New medicine for rare neurodegenerative disorder in children", "press_release": "Yes", "related_medicine_referral": "Brineura", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-rare-neurodegenerative-disorder-children" }, { "title": "Revised guidelines to encourage development of veterinary medicines for minor uses and minor species", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Regulatory and procedural guidance;Veterinary limited markets", "news_summary": "", "first_published_date": "21/04/2017", "last_updated_date": "21/04/2017", "news_url": "https://www.ema.europa.eu/en/news/revised-guidelines-encourage-development-veterinary-medicines-minor-uses-minor-species" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 April 2017", "press_release": "Yes", "related_medicine_referral": "Prevomax;Activyl Tick Plus;Vectra Felis;Cardalis;Versican Plus DHPPi/L4R;Zycortal;Versican Plus DHPPi/L4;Suvaxyn Circo+MH RTU;Purevax FeLV;Porcilis PCV M Hyo;Porcilis ColiClos;Parvoduk;Panacur AquaSol;Oncept IL-2;NexGard;Contacera;Improvac;Equip WNV (previously Duvaxyn WNV);Draxxin;BTVPUR AlSap 2-4;Broadline;Aivlosin;Zulvac 1 Bovis;Zulvac SBV;Zulvac 1 Ovis;Zulvac 1+8 Ovis;Zulvac 8 Bovis;Zulvac 8 Ovis;Zulvac 1+8 Bovis;Suvaxyn Circo+MH RTU", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/04/2017", "last_updated_date": "18/04/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-april-2017" }, { "title": "Update of EMA recommendations for 2017/2018 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/04/2017", "last_updated_date": "12/04/2017", "news_url": "https://www.ema.europa.eu/en/news/update-ema-recommendations-2017-2018-seasonal-flu-vaccine-composition" }, { "title": "European Medicines Agency closed 13-17 April 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "11/04/2017", "last_updated_date": "11/04/2017", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-13-17-april-2017" }, { "title": "Reporting irregularities that may affect medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/04/2017", "last_updated_date": "10/04/2017", "news_url": "https://www.ema.europa.eu/en/news/reporting-irregularities-may-affect-medicines" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 April 2017", "press_release": "No", "related_medicine_referral": "Uptravi;Gadolinium-containing contrast agents", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/04/2017", "last_updated_date": "07/04/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-april-2017" }, { "title": "EMA concludes safety review of Uptravi", "press_release": "Yes", "related_medicine_referral": "Uptravi", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "07/04/2017", "last_updated_date": "07/04/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-concludes-safety-review-uptravi" }, { "title": "Optimising safety information for medicines in Europe throughout product lifecycle", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/04/2017", "last_updated_date": "06/04/2017", "news_url": "https://www.ema.europa.eu/en/news/optimising-safety-information-medicines-europe-throughout-product-lifecycle" }, { "title": "EU cooperation on rare diseases honoured with new EU Ombudsman prize", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/04/2017", "last_updated_date": "06/04/2017", "news_url": "https://www.ema.europa.eu/en/news/eu-cooperation-rare-diseases-honoured-new-eu-ombudsman-prize" }, { "title": "Collaboration with academia to be reinforced", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/04/2017", "last_updated_date": "03/04/2017", "news_url": "https://www.ema.europa.eu/en/news/collaboration-academia-be-reinforced" }, { "title": "Regulatory information - adjusted fees for applications to EMA from 1 April 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/03/2017", "last_updated_date": "31/03/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2017-0" }, { "title": "EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs", "press_release": "Yes", "related_medicine_referral": "Micro Therapeutic Research", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/03/2017", "last_updated_date": "24/03/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-suspension-medicines-due-unreliable-studies-micro-therapeutic-research-labs" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 March 2017", "press_release": "No", "related_medicine_referral": "Translarna;Enpaxiq;Zebinix;Opdivo;Keytruda;Ivabradine Accord;Elmiron;Trumenba;Refixia;Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron);Axumin;Blectifor;Micro Therapeutic Research", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/03/2017", "last_updated_date": "24/03/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-march-2017" }, { "title": "EU recommendations for 2017/2018 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/03/2017", "last_updated_date": "24/03/2017", "news_url": "https://www.ema.europa.eu/en/news/eu-recommendations-2017-2018-seasonal-flu-vaccine-composition" }, { "title": "Use of big data to improve human and animal health", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/03/2017", "last_updated_date": "23/03/2017", "news_url": "https://www.ema.europa.eu/en/news/use-big-data-improve-human-animal-health" }, { "title": "Call for experts in anonymisation of clinical data", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/03/2017", "last_updated_date": "22/03/2017", "news_url": "https://www.ema.europa.eu/en/news/call-experts-anonymisation-clinical-data" }, { "title": "First anniversary of PRIME – experience so far", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "22/03/2017", "last_updated_date": "22/03/2017", "news_url": "https://www.ema.europa.eu/en/news/first-anniversary-prime-experience-so-far" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 March 2017", "press_release": "Yes", "related_medicine_referral": "Stronghold;Novem;Ingelvac PCV FLEX;Zeleris;Respiporc FLUpan H1N1;Nexgard Spectra;ProZinc;Bravecto;Poulvac E. coli;Zactran;Suprelorin", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/03/2017", "last_updated_date": "17/03/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-march-2017" }, { "title": "EMA Management Board: highlights of March 2017 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/03/2017", "last_updated_date": "17/03/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2017-meeting" }, { "title": "Release of documents on two medicines temporarily halted", "press_release": "No", "related_medicine_referral": "Translarna;Bravecto", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/03/2017", "last_updated_date": "14/03/2017", "news_url": "https://www.ema.europa.eu/en/news/release-documents-two-medicines-temporarily-halted" }, { "title": "PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations", "press_release": "Yes", "related_medicine_referral": "Optimark;Gadolinium-containing contrast agents", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/03/2017", "last_updated_date": "10/03/2017", "news_url": "https://www.ema.europa.eu/en/news/prac-concludes-assessment-gadolinium-agents-used-body-scans-recommends-regulatory-actions-including-suspension-some-marketing-authorisations" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 March 2017", "press_release": "No", "related_medicine_referral": "Gadolinium-containing contrast agents;Valproate and related substances", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "10/03/2017", "last_updated_date": "10/03/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-march-2017" }, { "title": "EMA reviewing cancer medicine docetaxel", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "10/03/2017", "last_updated_date": "10/03/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-reviewing-cancer-medicine-docetaxel" }, { "title": "Regulatory cooperation to improve global health", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/03/2017", "last_updated_date": "10/03/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-cooperation-improve-global-health" }, { "title": "Personalised medicines – focus on patients and healthcare professionals", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/03/2017", "last_updated_date": "07/03/2017", "news_url": "https://www.ema.europa.eu/en/news/personalised-medicines-focus-patients-healthcare-professionals" }, { "title": "European and US regulators agree on mutual recognition of inspections of medicines manufacturers", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "02/03/2017", "last_updated_date": "02/03/2017", "news_url": "https://www.ema.europa.eu/en/news/european-us-regulators-agree-mutual-recognition-inspections-medicines-manufacturers" }, { "title": "EMA website briefly unavailable on 3 March", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/03/2017", "last_updated_date": "02/03/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-3-march" }, { "title": "Regulatory information – adjusted fees for applications to EMA from 1 April 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/02/2017", "last_updated_date": "28/02/2017", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2017" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017", "press_release": "No", "related_medicine_referral": "Truvada;Natpar;Varuby;Lokelma;Tafinlar;Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited);Mekinist;Roteas;Emtricitabine/Tenofovir disoproxil Krka d.d.;Darzalex;Saroten and associated names;SGLT2 inhibitors (previously canagliflozin);Haldol and associated names;Haldol Decanoate and associated names", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/02/2017", "last_updated_date": "24/02/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-february-2017" }, { "title": "First hormone replacement therapy for parathyroid disorder", "press_release": "Yes", "related_medicine_referral": "Natpar", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/02/2017", "last_updated_date": "24/02/2017", "news_url": "https://www.ema.europa.eu/en/news/first-hormone-replacement-therapy-parathyroid-disorder" }, { "title": "SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information", "press_release": "Yes", "related_medicine_referral": "SGLT2 inhibitors (previously canagliflozin)", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/02/2017", "last_updated_date": "24/02/2017", "news_url": "https://www.ema.europa.eu/en/news/sglt2-inhibitors-information-potential-risk-toe-amputation-be-included-prescribing-information" }, { "title": "First monoclonal antibody in veterinary medicine recommended for a marketing authorisation", "press_release": "Yes", "related_medicine_referral": "Cytopoint", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/02/2017", "last_updated_date": "17/02/2017", "news_url": "https://www.ema.europa.eu/en/news/first-monoclonal-antibody-veterinary-medicine-recommended-marketing-authorisation" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 February 2017", "press_release": "Yes", "related_medicine_referral": "BTVPUR;Zulvac BTV;Cytopoint;Credelio;Nobivac L4;Canigen L4;Zulvac 1+8 Bovis;Vaxxitek HVT+IBD;ProteqFlu-Te;ProteqFlu;Previcox;Incurin;Imrestor;Fungitraxx;Fortekor Plus;Evalon;Econor;Coliprotec F4;Bovalto Ibraxion", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/02/2017", "last_updated_date": "17/02/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-february-2017" }, { "title": "Consultation on revised policy on access to documents", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/02/2017", "last_updated_date": "17/02/2017", "news_url": "https://www.ema.europa.eu/en/news/consultation-revised-policy-access-documents" }, { "title": "Martina Schüssler-Lenz elected as new chair of Committee for Advanced Therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "17/02/2017", "last_updated_date": "17/02/2017", "news_url": "https://www.ema.europa.eu/en/news/martina-schussler-lenz-elected-new-chair-committee-advanced-therapies" }, { "title": "EMA reviewing safety of Uptravi for pulmonary arterial hypertension (updated)*", "press_release": "Yes", "related_medicine_referral": "Uptravi", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "14/02/2017", "last_updated_date": "14/02/2017", "news_url": "https://www.ema.europa.eu/en/news/ema-reviewing-safety-uptravi-pulmonary-arterial-hypertension-updated" }, { "title": "Over 1,000 studies now recorded in EU register of post-authorisation studies", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "10/02/2017", "last_updated_date": "10/02/2017", "news_url": "https://www.ema.europa.eu/en/news/over-1000-studies-now-recorded-eu-register-post-authorisation-studies" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 February 2017", "press_release": "No", "related_medicine_referral": "Uptravi;Quinolone- and fluoroquinolone-containing medicinal products;SGLT2 inhibitors (previously canagliflozin)", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/02/2017", "last_updated_date": "10/02/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-february-2017" }, { "title": "Promoting high-quality clinical research in children through strengthened international collaboration", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "09/02/2017", "last_updated_date": "09/02/2017", "news_url": "https://www.ema.europa.eu/en/news/promoting-high-quality-clinical-research-children-through-strengthened-international-collaboration" }, { "title": "Advanced therapy medicines: towards increased development and patient access", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/02/2017", "last_updated_date": "03/02/2017", "news_url": "https://www.ema.europa.eu/en/news/advanced-therapy-medicines-towards-increased-development-patient-access" }, { "title": "Clinical data for two more medicines now available online", "press_release": "No", "related_medicine_referral": "Palonosetron Hospira;Aripiprazole Mylan", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/02/2017", "last_updated_date": "01/02/2017", "news_url": "https://www.ema.europa.eu/en/news/clinical-data-two-more-medicines-now-available-online" }, { "title": "Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed", "press_release": "Yes", "related_medicine_referral": "Dienogest/ethinylestradiol-containing medicinal products indicated in acne", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/01/2017", "last_updated_date": "27/01/2017", "news_url": "https://www.ema.europa.eu/en/news/dienogest-ethinylestradiol-can-be-used-acne-after-certain-other-treatments-have-failed" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2017", "press_release": "No", "related_medicine_referral": "Synjardy;Yargesa;Xgeva;Amgevita;Solymbic;Revlimid;Xeljanz;Zioxtenzo;Jylamvo;Tadalafil Lilly;Rolufta Ellipta (previously Rolufta);Daptomycin Hospira;Dienogest/ethinylestradiol-containing medicinal products indicated in acne", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/01/2017", "last_updated_date": "27/01/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-january-2017" }, { "title": "Veterinary medicines: highlights of 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "24/01/2017", "last_updated_date": "25/01/2017", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2016" }, { "title": "It's time to reduce, replace and re-think the use of antimicrobials in animals", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/01/2017", "last_updated_date": "24/01/2017", "news_url": "https://www.ema.europa.eu/en/news/its-time-reduce-replace-re-think-use-antimicrobials-animals" }, { "title": "Conditional marketing authorisations give patients access to important new medicines earlier", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "23/01/2017", "last_updated_date": "23/01/2017", "news_url": "https://www.ema.europa.eu/en/news/conditional-marketing-authorisations-give-patients-access-important-new-medicines-earlier" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 January 2017", "press_release": "Yes", "related_medicine_referral": "Respiporc Flu3;Osurnia;Broadline;Bravecto;Versican Plus DHPPi/L4;Versican Plus DHPPi;Vectormune ND;Startvac;Semintra;Pexion;Novaquin;Nobilis IB Primo QX;Nobilis IB 4-91;Neocolipor;Bovilis BTV8;Activyl;Porcilis ColiClos;Nobivac L4;Prac-tic;Onsior;Fortekor Plus;Econor;Zolvix;Clomicalm;Zulvac 1 Bovis;Zulvac 8 Ovis;Zulvac 1+8 Bovis;Zulvac 1 Ovis;Zulvac 8 Bovis", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/01/2017", "last_updated_date": "20/01/2017", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-17-19-january-2017" }, { "title": "Human medicines: highlights of 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "17/01/2017", "last_updated_date": "17/01/2017", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2016" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 January 2017", "press_release": "No", "related_medicine_referral": "SGLT2 inhibitors (previously canagliflozin);Paracetamol modified-release;Factor VIII;Retinoid-containing medicinal products;Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions;Gadolinium-containing contrast agents", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/01/2017", "last_updated_date": "13/01/2017", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-january-2017" }, { "title": "Clinical data for two more medicines now available online", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/12/2016", "last_updated_date": "21/12/2016", "news_url": "https://www.ema.europa.eu/en/news/clinical-data-two-more-medicines-now-available-online-0" }, { "title": "Simpler website navigation for regulatory information on veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/12/2016", "last_updated_date": "20/12/2016", "news_url": "https://www.ema.europa.eu/en/news/simpler-website-navigation-regulatory-information-veterinary-medicines" }, { "title": "European Medicines Agency closed 23 December 2016 to 2 January 2017", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "20/12/2016", "last_updated_date": "20/12/2016", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-23-december-2016-2-january-2017" }, { "title": "EMA Management Board: highlights of December 2016 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/12/2016", "last_updated_date": "19/12/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2016-meeting" }, { "title": "EMA website briefly unavailable on 20 December", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/12/2016", "last_updated_date": "19/12/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-20-december" }, { "title": "Tailored scientific advice to support step-by-step development of new biosimilars", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Biosimilars", "news_summary": "", "first_published_date": "16/12/2016", "last_updated_date": "16/12/2016", "news_url": "https://www.ema.europa.eu/en/news/tailored-scientific-advice-support-step-step-development-new-biosimilars" }, { "title": "New oral treatment for rheumatoid arthritis", "press_release": "Yes", "related_medicine_referral": "Olumiant", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/12/2016", "last_updated_date": "16/12/2016", "news_url": "https://www.ema.europa.eu/en/news/new-oral-treatment-rheumatoid-arthritis" }, { "title": "Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B", "press_release": "Yes", "related_medicine_referral": "Viekirax;Harvoni;Olysio;Sovaldi;Daklinza;Exviera;Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/12/2016", "last_updated_date": "16/12/2016", "news_url": "https://www.ema.europa.eu/en/news/direct-acting-antivirals-hepatitis-c-ema-confirms-recommendation-screen-hepatitis-b" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016", "press_release": "No", "related_medicine_referral": "Alecensa;Ledaga;Zinplava;Arzerra;Votubia;Repatha;Inovelon;Tivicay;Repatha;Keytruda;Jardiance;Ilaris;Cinryze;Ameluz;Kepnetic;Graspa;Efgratin;Cavoley;Lifmior;Pregabalin Zentiva k.s.;Vihuma;Truxima;Olumiant;Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free);Lovenox and associated names;Micro Therapeutic Research", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/12/2016", "last_updated_date": "16/12/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-december-2016" }, { "title": "EMA hosts workshop on adaptive pathways", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/12/2016", "last_updated_date": "13/12/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-hosts-workshop-adaptive-pathways" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting 6-8 December 2016", "press_release": "Yes", "related_medicine_referral": "Stronghold Plus;Equioxx;Respiporc FLUpan H1N1;Rheumocam;Loxicom;Easotic;Zulvac 8 Ovis;Zulvac 8 Bovis;Zactran;Zulvac SBV;Versican Plus Pi/L4R;Versican Plus Pi;UpCard;Suvaxyn PCV;ProZinc;Porcilis PCV ID;Nexgard Spectra;Kexxtone;Versican Plus L4;Innovax-ILT;Eryseng Parvo;Eryseng;Ecoporc Shiga;Broadline;Aivlosin", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/12/2016", "last_updated_date": "09/12/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-december-2016" }, { "title": "EMA website briefly unavailable on 9 December", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/12/2016", "last_updated_date": "08/12/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-9-december" }, { "title": "PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C", "press_release": "Yes", "related_medicine_referral": "Exviera;Viekirax;Olysio;Sovaldi;Daklinza;Harvoni;Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "02/12/2016", "last_updated_date": "02/12/2016", "news_url": "https://www.ema.europa.eu/en/news/prac-warns-risk-hepatitis-b-re-activation-direct-acting-antivirals-hepatitis-c" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2016", "press_release": "No", "related_medicine_referral": "Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free);Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "02/12/2016", "last_updated_date": "02/12/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-november-1-december-2016" }, { "title": "Simpler website navigation for regulatory information on human medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/12/2016", "last_updated_date": "01/12/2016", "news_url": "https://www.ema.europa.eu/en/news/simpler-website-navigation-regulatory-information-human-medicines" }, { "title": "Workshop on adaptive pathways – discussion on development approach for medicines addressing unmet medical needs", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/12/2016", "last_updated_date": "01/12/2016", "news_url": "https://www.ema.europa.eu/en/news/workshop-adaptive-pathways-discussion-development-approach-medicines-addressing-unmet-medical-needs" }, { "title": "Kaisa Immonen elected as new co-chair of Patients' and Consumers' Working Party", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/12/2016", "last_updated_date": "01/12/2016", "news_url": "https://www.ema.europa.eu/en/news/kaisa-immonen-elected-new-co-chair-patients-consumers-working-party" }, { "title": "Development challenges for medicines for central nervous system disorders", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/11/2016", "last_updated_date": "29/11/2016", "news_url": "https://www.ema.europa.eu/en/news/development-challenges-medicines-central-nervous-system-disorders" }, { "title": "EMA website briefly unavailable on 29 November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/11/2016", "last_updated_date": "28/11/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-29-november" }, { "title": "Workshop: measuring the impact of pharmacovigilance activities", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/11/2016", "last_updated_date": "28/11/2016", "news_url": "https://www.ema.europa.eu/en/news/workshop-measuring-impact-pharmacovigilance-activities" }, { "title": "Active pharmaceutical ingredients: Japan joins international collaboration on GMP inspections", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "25/11/2016", "last_updated_date": "25/11/2016", "news_url": "https://www.ema.europa.eu/en/news/active-pharmaceutical-ingredients-japan-joins-international-collaboration-gmp-inspections" }, { "title": "Marisa Delbò elected as new chair of herbal medicines committee", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/11/2016", "last_updated_date": "24/11/2016", "news_url": "https://www.ema.europa.eu/en/news/marisa-delbo-elected-new-chair-herbal-medicines-committee" }, { "title": "Clinical data for two more medicines now available online", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/11/2016", "last_updated_date": "24/11/2016", "news_url": "https://www.ema.europa.eu/en/news/clinical-data-two-more-medicines-now-available-online-1" }, { "title": "Workshop: towards new treatments for tuberculosis", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/11/2016", "last_updated_date": "18/11/2016", "news_url": "https://www.ema.europa.eu/en/news/workshop-towards-new-treatments-tuberculosis" }, { "title": "Regulatory information – New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/11/2016", "last_updated_date": "18/11/2016", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-new-guidance-type-ii-variations-marketing-authorisation-extensions-orphan-designated-medicines" }, { "title": "EMA website briefly unavailable on 18 November", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/11/2016", "last_updated_date": "17/11/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-18-november" }, { "title": "Webinar: How can clinical research networks support developers of medicines for children?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "16/11/2016", "last_updated_date": "16/11/2016", "news_url": "https://www.ema.europa.eu/en/news/webinar-how-can-clinical-research-networks-support-developers-medicines-children" }, { "title": "The European Commission launches a public consultation on the Paediatric Regulation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Paediatrics", "news_summary": "", "first_published_date": "15/11/2016", "last_updated_date": "15/11/2016", "news_url": "https://www.ema.europa.eu/en/news/european-commission-launches-public-consultation-paediatric-regulation" }, { "title": "Revising the guideline on first-in-human clinical trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "15/11/2016", "last_updated_date": "15/11/2016", "news_url": "https://www.ema.europa.eu/en/news/revising-guideline-first-human-clinical-trials" }, { "title": "Modelling and simulation in the development of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/11/2016", "last_updated_date": "14/11/2016", "news_url": "https://www.ema.europa.eu/en/news/modelling-simulation-development-medicines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 November 2016", "press_release": "Yes", "related_medicine_referral": "Coxevac;Trifexis;Coliprotec F4/F18;Novem;Vectra Felis;Vectra 3D;Sileo;Prac-tic;Poulvac E. coli;Inflacam;Bovela;Versican Plus DHPPi/L4R;Versican Plus DHPPi/L4;Versican Plus DHPPi;Purevax RCPCh;Purevax RCP FeLV;Purevax RC;Purevax RCP;Purevax RCPCh FeLV;Easotic;Cortavance;Metacam", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/11/2016", "last_updated_date": "11/11/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-november-2016" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016", "press_release": "No", "related_medicine_referral": "Arzerra;Vimpat;Caprelsa;Vemlidy;Terrosa;Fiasp;Ruconest;Suliqua;Movymia;Lusduna;Darunavir Viatris (previously Darunavir Mylan);Talmanco (previously Tadalafil Generics);Afstyla;Nimenrix;Humira", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "11/11/2016", "last_updated_date": "11/11/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-7-10-november-2016" }, { "title": "How to facilitate development of cancer treatment based on genetically modified T-cells", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/11/2016", "last_updated_date": "08/11/2016", "news_url": "https://www.ema.europa.eu/en/news/how-facilitate-development-cancer-treatment-based-genetically-modified-t-cells" }, { "title": "How big data can be used for the development and regulation of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/11/2016", "last_updated_date": "08/11/2016", "news_url": "https://www.ema.europa.eu/en/news/how-big-data-can-be-used-development-regulation-medicines" }, { "title": "Workshop: working towards new therapies for spinal muscular atrophy", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/11/2016", "last_updated_date": "07/11/2016", "news_url": "https://www.ema.europa.eu/en/news/workshop-working-towards-new-therapies-spinal-muscular-atrophy" }, { "title": "Webinar on regulatory and procedural aspects of applications for type I variations", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/11/2016", "last_updated_date": "04/11/2016", "news_url": "https://www.ema.europa.eu/en/news/webinar-regulatory-procedural-aspects-applications-type-i-variations" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24-27 October 2016", "press_release": "No", "related_medicine_referral": "Gadolinium-containing contrast agents;Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free);SGLT2 inhibitors (previously canagliflozin);Retinoid-containing medicinal products;Paracetamol modified-release;Factor VIII", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "28/10/2016", "last_updated_date": "28/10/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-october-2016" }, { "title": "EMA closed from 28 October to 3 November 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/10/2016", "last_updated_date": "27/10/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-closed-28-october-3-november-2016" }, { "title": "New search page for periodic safety update report single assessments (PSUSAs)", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/10/2016", "last_updated_date": "26/10/2016", "news_url": "https://www.ema.europa.eu/en/news/new-search-page-periodic-safety-update-report-single-assessments-psusas" }, { "title": "Regulatory update – EMA encourages companies to submit Type I variations for 2016 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/10/2016", "last_updated_date": "24/10/2016", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2016-end-november" }, { "title": "How to make better use of patient registries to collect high-quality data on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/10/2016", "last_updated_date": "24/10/2016", "news_url": "https://www.ema.europa.eu/en/news/how-make-better-use-patient-registries-collect-high-quality-data-medicines" }, { "title": "Opening up clinical data on new medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/10/2016", "last_updated_date": "20/10/2016", "news_url": "https://www.ema.europa.eu/en/news/opening-clinical-data-new-medicines" }, { "title": "Regulatory information – Updated SME user guide now available", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "19/10/2016", "last_updated_date": "19/10/2016", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-updated-sme-user-guide-now-available" }, { "title": "New medicine for rare, chronic liver disease", "press_release": "Yes", "related_medicine_referral": "Ocaliva", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "14/10/2016", "last_updated_date": "14/10/2016", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-rare-chronic-liver-disease" }, { "title": "EMA recommends measures to ensure safe use of Keppra oral solution", "press_release": "Yes", "related_medicine_referral": "Keppra", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "14/10/2016", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-measures-ensure-safe-use-keppra-oral-solution" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016", "press_release": "No", "related_medicine_referral": "Cystadrops;Ocaliva;Zebinix;Trisenox;Opdivo;Lucentis;Zemfirza;Pemetrexed ditromethamine Hospira;Ertapenem Hospira;Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan);Emtricitabine/Tenofovir disoproxil Krka;Emtricitabine/Tenofovir disoproxil Mylan;Venclyxto;SomaKit TOC;Rekovelle;Metformin and metformin-containing medicines", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "14/10/2016", "last_updated_date": "14/10/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-october-2016" }, { "title": "Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function", "press_release": "Yes", "related_medicine_referral": "Competact;Zomarist;Xigduo;Vokanamet;Vipdomet;Velmetia;Synjardy;Ristfor;Komboglyze;Jentadueto;Janumet;Icandra (previously Vildagliptin / metformin hydrochloride Novartis);Glubrava;Eucreas;Efficib;Ebymect;Metformin and metformin-containing medicines", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "14/10/2016", "last_updated_date": "14/10/2016", "news_url": "https://www.ema.europa.eu/en/news/use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function" }, { "title": "Sales of veterinary antibiotics continue to decline in most European countries", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/10/2016", "last_updated_date": "14/10/2016", "news_url": "https://www.ema.europa.eu/en/news/sales-veterinary-antibiotics-continue-decline-most-european-countries" }, { "title": "First comprehensive overview of global initiatives on medicine regulation published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/10/2016", "last_updated_date": "13/10/2016", "news_url": "https://www.ema.europa.eu/en/news/first-comprehensive-overview-global-initiatives-medicine-regulation-published" }, { "title": "EMA Management Board: highlights of October 2016 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/10/2016", "last_updated_date": "07/10/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2016-meeting" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 October 2016", "press_release": "Yes", "related_medicine_referral": "Cepedex;Zulvac 1+8 Bovis;Activyl Tick Plus;CaniLeish;Virbagen Omega;Advocate;Naxcel;Equip WNV (previously Duvaxyn WNV);Bluevac BTV (previously Bluevac BTV8);MS-H Vaccine;RevitaCAM;Comfortis;Apoquel;Porcilis PCV M Hyo;Simparica;Suvaxyn Circo+MH RTU;VarroMed;Halagon", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "07/10/2016", "last_updated_date": "07/10/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-4-6-october-2016" }, { "title": "New medicine to protect honey bees against Varroa mites", "press_release": "Yes", "related_medicine_referral": "VarroMed", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "07/10/2016", "last_updated_date": "07/10/2016", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-protect-honey-bees-against-varroa-mites" }, { "title": "IT systems unavailable from 28 October to 1 November 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/10/2016", "last_updated_date": "06/10/2016", "news_url": "https://www.ema.europa.eu/en/news/it-systems-unavailable-28-october-1-november-2016" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2016", "press_release": "No", "related_medicine_referral": "Gadolinium-containing contrast agents;Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free);SGLT2 inhibitors (previously canagliflozin);Retinoid-containing medicinal products;Paracetamol modified-release;Factor VIII", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "30/09/2016", "last_updated_date": "30/09/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-september-2016" }, { "title": "New judicial decisions at odds with EMA's efforts to allow access to documents on medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/09/2016", "last_updated_date": "29/09/2016", "news_url": "https://www.ema.europa.eu/en/news/new-judicial-decisions-odds-emas-efforts-allow-access-documents-medicines" }, { "title": "EU-US collaboration to boost medicine development for rare diseases", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/09/2016", "last_updated_date": "26/09/2016", "news_url": "https://www.ema.europa.eu/en/news/eu-us-collaboration-boost-medicine-development-rare-diseases" }, { "title": "Healthcare professionals' working party elects co-chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/09/2016", "last_updated_date": "21/09/2016", "news_url": "https://www.ema.europa.eu/en/news/healthcare-professionals-working-party-elects-co-chair" }, { "title": "Zika virus infection: plasma- and urine-derived medicines safe to use", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/09/2016", "last_updated_date": "21/09/2016", "news_url": "https://www.ema.europa.eu/en/news/zika-virus-infection-plasma-urine-derived-medicines-safe-use" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)", "press_release": "No", "related_medicine_referral": "Glyxambi;Ibrance;Ninlaro;Ivabradine JensonR;Adempas;Abilify;Stelara;NovoRapid;Cokiera;Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau);Ivabradine Zentiva;Granpidam;Emtricitabine/Tenofovir disoproxil Zentiva;Parsabiv;Lartruvo;Pharmaceutics International Inc.;Clenil and associated names", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/09/2016", "last_updated_date": "21/09/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-september-2016-corrected" }, { "title": "Paediatric Committee re-elects chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "16/09/2016", "last_updated_date": "16/09/2016", "news_url": "https://www.ema.europa.eu/en/news/paediatric-committee-re-elects-chair" }, { "title": "New treatment for patients with soft tissue sarcoma", "press_release": "Yes", "related_medicine_referral": "Lartruvo", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/09/2016", "last_updated_date": "16/09/2016", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-patients-soft-tissue-sarcoma" }, { "title": "New treatment for breast cancer", "press_release": "Yes", "related_medicine_referral": "Ibrance", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/09/2016", "last_updated_date": "16/09/2016", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-breast-cancer" }, { "title": "Pharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped due to manufacturing failings", "press_release": "Yes", "related_medicine_referral": "Ammonaps;Pharmaceutics International Inc.", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/09/2016", "last_updated_date": "16/09/2016", "news_url": "https://www.ema.europa.eu/en/news/pharmaceutics-international-inc-us-supply-non-critical-medicines-eu-be-stopped-due-manufacturing-failings" }, { "title": "EMA survey on initial marketing authorisation application 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/09/2016", "last_updated_date": "15/09/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-survey-initial-marketing-authorisation-application-2016" }, { "title": "Progress made in the operation of EU pharmacovigilance legislation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/09/2016", "last_updated_date": "14/09/2016", "news_url": "https://www.ema.europa.eu/en/news/progress-made-operation-eu-pharmacovigilance-legislation" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 September 2016", "press_release": "Yes", "related_medicine_referral": "Draxxin;Bovela;Versican Plus DHPPi/L4;Velactis;Recuvyra;Parvoduk;Meloxidolor;Bravecto;Halocur;Versican Plus L4;Versican Plus Pi/L4;Versican Plus Pi;Versican Plus DHPPi;Rheumocam;Inflacam", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/09/2016", "last_updated_date": "09/09/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-september-2016" }, { "title": "Head of International Affairs, Emer Cooke, to leave European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "09/09/2016", "last_updated_date": "09/09/2016", "news_url": "https://www.ema.europa.eu/en/news/head-international-affairs-emer-cooke-leave-european-medicines-agency" }, { "title": "Fighting antimicrobial resistance globally", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/09/2016", "last_updated_date": "07/09/2016", "news_url": "https://www.ema.europa.eu/en/news/fighting-antimicrobial-resistance-globally" }, { "title": "Workshop on adaptive pathways - discussing a concept for development of medicines addressing unmet medical needs", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/09/2016", "last_updated_date": "07/09/2016", "news_url": "https://www.ema.europa.eu/en/news/workshop-adaptive-pathways-discussing-concept-development-medicines-addressing-unmet-medical-needs" }, { "title": "Call for civil society members in Paediatric Committee", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "06/09/2016", "last_updated_date": "06/09/2016", "news_url": "https://www.ema.europa.eu/en/news/call-civil-society-members-paediatric-committee" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August - 2 September 2016", "press_release": "No", "related_medicine_referral": "Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free);SGLT2 inhibitors (previously canagliflozin);Factor VIII;Retinoid-containing medicinal products;Paracetamol modified-release;Gadolinium-containing contrast agents", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "02/09/2016", "last_updated_date": "02/09/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-30-august-2-september-2016" }, { "title": "European Medicines Agency closed 29 August 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "25/08/2016", "last_updated_date": "25/08/2016", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-29-august-2016" }, { "title": "Addressing challenges of innovative cancer immunotherapy medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Innovation", "news_summary": "", "first_published_date": "16/08/2016", "last_updated_date": "16/08/2016", "news_url": "https://www.ema.europa.eu/en/news/addressing-challenges-innovative-cancer-immunotherapy-medicines" }, { "title": "Better monitoring of biological medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Biologicals", "news_summary": "", "first_published_date": "15/08/2016", "last_updated_date": "15/08/2016", "news_url": "https://www.ema.europa.eu/en/news/better-monitoring-biological-medicines" }, { "title": "Data integrity: key to public health protection", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/08/2016", "last_updated_date": "11/08/2016", "news_url": "https://www.ema.europa.eu/en/news/data-integrity-key-public-health-protection" }, { "title": "EU collaboration strengthens safety monitoring of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/08/2016", "last_updated_date": "08/08/2016", "news_url": "https://www.ema.europa.eu/en/news/eu-collaboration-strengthens-safety-monitoring-medicines" }, { "title": "Transparency in drug regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/08/2016", "last_updated_date": "05/08/2016", "news_url": "https://www.ema.europa.eu/en/news/transparency-drug-regulation" }, { "title": "Increasing the availability of veterinary vaccines in the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/08/2016", "last_updated_date": "04/08/2016", "news_url": "https://www.ema.europa.eu/en/news/increasing-availability-veterinary-vaccines-eu" }, { "title": "Adaptive pathways: key learnings and next steps", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "03/08/2016", "last_updated_date": "03/08/2016", "news_url": "https://www.ema.europa.eu/en/news/adaptive-pathways-key-learnings-next-steps" }, { "title": "New layout for EMA scientific guidelines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "02/08/2016", "last_updated_date": "02/08/2016", "news_url": "https://www.ema.europa.eu/en/news/new-layout-ema-scientific-guidelines" }, { "title": "Development of medicines to treat tuberculosis", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/08/2016", "last_updated_date": "01/08/2016", "news_url": "https://www.ema.europa.eu/en/news/development-medicines-treat-tuberculosis" }, { "title": "Modelling and simulation in the development and regulatory review of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/07/2016", "last_updated_date": "29/07/2016", "news_url": "https://www.ema.europa.eu/en/news/modelling-simulation-development-regulatory-review-medicines" }, { "title": "Building a leaner, more streamlined organisation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/07/2016", "last_updated_date": "29/07/2016", "news_url": "https://www.ema.europa.eu/en/news/building-leaner-more-streamlined-organisation" }, { "title": "Better identification of medicinal products", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/07/2016", "last_updated_date": "28/07/2016", "news_url": "https://www.ema.europa.eu/en/news/better-identification-medicinal-products" }, { "title": "Countries should reduce use of colistin in animals to decrease the risk of antimicrobial resistance", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/07/2016", "last_updated_date": "27/07/2016", "news_url": "https://www.ema.europa.eu/en/news/countries-should-reduce-use-colistin-animals-decrease-risk-antimicrobial-resistance" }, { "title": "Two new medicines for advanced kidney cancer", "press_release": "Yes", "related_medicine_referral": "Cabometyx;Kisplyx", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "news_url": "https://www.ema.europa.eu/en/news/two-new-medicines-advanced-kidney-cancer" }, { "title": "First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU", "press_release": "Yes", "related_medicine_referral": "Truvada", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "news_url": "https://www.ema.europa.eu/en/news/first-medicine-hiv-pre-exposure-prophylaxis-recommended-approval-eu" }, { "title": "EMA recommends suspension of medicines over flawed studies at Semler Research Centre", "press_release": "Yes", "related_medicine_referral": "Semler", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-suspension-medicines-over-flawed-studies-semler-research-centre" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2016", "press_release": "No", "related_medicine_referral": "Cabometyx;Kisplyx;Begedina;Xalkori;Truvada;Zydelig;Orencia;Imbruvica;Ameluz;Thorinane;Inhixa;Tenofovir disoproxil Zentiva;Sialanar;Truberzi;Onivyde pegylated liposomal (previously Onivyde);Zydelig;Semler;Durogesic and associated names;Diclofenac epolamine 50 mg tablets", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-july-2016" }, { "title": "CHMP confirms recommendations for use of Zydelig", "press_release": "Yes", "related_medicine_referral": "Zydelig;Zydelig", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "news_url": "https://www.ema.europa.eu/en/news/chmp-confirms-recommendations-use-zydelig" }, { "title": "EMA website briefly unavailable on 25 July", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-website-briefly-unavailable-25-july" }, { "title": "Proposals to revise guidance on first-in-human clinical trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/07/2016", "last_updated_date": "21/07/2016", "news_url": "https://www.ema.europa.eu/en/news/proposals-revise-guidance-first-human-clinical-trials" }, { "title": "EMA recommends suspending the veterinary medicine Velactis used in dairy cows at the time of drying off", "press_release": "Yes", "related_medicine_referral": "Velactis", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/07/2016", "last_updated_date": "15/07/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-suspending-veterinary-medicine-velactis-used-dairy-cows-time-drying" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2016", "press_release": "Yes", "related_medicine_referral": "Suvaxyn Circo+MH RTU;Vectormune ND;Velactis;Eravac;Nobilis IB 4-91;Nobivac Bb;Dexdomitor;Suprelorin;Bluevac BTV (previously Bluevac BTV8);Comfortis;Zulvac 1 Ovis;Proteq West Nile;Purevax Rabies;Zulvac 1+8 Ovis;Nobilis IB Primo QX;NexGard;Trifexis", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/07/2016", "last_updated_date": "15/07/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-12-14-july-2016" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-8 July 2016", "press_release": "No", "related_medicine_referral": "Zydelig;SGLT2 inhibitors (previously canagliflozin);Paracetamol modified-release;Retinoid-containing medicinal products;Factor VIII", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "08/07/2016", "last_updated_date": "08/07/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-8-july-2016" }, { "title": "PRAC concludes review of Zydelig and issues updated recommendations for use", "press_release": "Yes", "related_medicine_referral": "Zydelig;Zydelig", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "08/07/2016", "last_updated_date": "08/07/2016", "news_url": "https://www.ema.europa.eu/en/news/prac-concludes-review-zydelig-issues-updated-recommendations-use" }, { "title": "Statement on the outcome of the UK referendum", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/07/2016", "last_updated_date": "06/07/2016", "news_url": "https://www.ema.europa.eu/en/news/statement-outcome-uk-referendum" }, { "title": "Procedural information – EMA goes electronic for PDCO opinions and subsequent EMA decisions", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "06/07/2016", "last_updated_date": "06/07/2016", "news_url": "https://www.ema.europa.eu/en/news/procedural-information-ema-goes-electronic-pdco-opinions-subsequent-ema-decisions" }, { "title": "Infringement procedure against Roche – EMA update", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/07/2016", "last_updated_date": "04/07/2016", "news_url": "https://www.ema.europa.eu/en/news/infringement-procedure-against-roche-ema-update" }, { "title": "Strengthening interaction with academia", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/06/2016", "last_updated_date": "30/06/2016", "news_url": "https://www.ema.europa.eu/en/news/strengthening-interaction-academia" }, { "title": "The role of single-arm trials in the authorisation of new cancer medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/06/2016", "last_updated_date": "27/06/2016", "news_url": "https://www.ema.europa.eu/en/news/role-single-arm-trials-authorisation-new-cancer-medicines" }, { "title": "EMA reviewing veterinary medicine Velactis", "press_release": "No", "related_medicine_referral": "Velactis", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/06/2016", "last_updated_date": "24/06/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-reviewing-veterinary-medicine-velactis" }, { "title": "New cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer", "press_release": "Yes", "related_medicine_referral": "Zalmoxis", "categories": "Human", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "24/06/2016", "last_updated_date": "24/06/2016", "news_url": "https://www.ema.europa.eu/en/news/new-cell-based-therapy-support-stem-cell-transplantation-patients-high-risk-blood-cancer" }, { "title": "Start of review of medicines manufactured at Pharmaceutics International Inc., USA", "press_release": "Yes", "related_medicine_referral": "Ammonaps;Pharmaceutics International Inc.", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/06/2016", "last_updated_date": "24/06/2016", "news_url": "https://www.ema.europa.eu/en/news/start-review-medicines-manufactured-pharmaceutics-international-inc-usa" }, { "title": "Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU", "press_release": "Yes", "related_medicine_referral": "Alkem", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/06/2016", "last_updated_date": "24/06/2016", "news_url": "https://www.ema.europa.eu/en/news/studies-alkem-laboratories-ltd-cannot-be-used-support-medicines-approval-eu" }, { "title": "Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia", "press_release": "Yes", "related_medicine_referral": "Adempas", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/06/2016", "last_updated_date": "24/06/2016", "news_url": "https://www.ema.europa.eu/en/news/adempas-not-use-patients-pulmonary-hypertension-caused-idiopathic-interstitial-pneumonia" }, { "title": "EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable", "press_release": "No", "related_medicine_referral": "Noxafil", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/06/2016", "last_updated_date": "", "news_url": "https://www.ema.europa.eu/en/news/ema-warns-noxafil-tablets-oral-suspension-have-different-doses-are-not-interchangeable" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016", "press_release": "No", "related_medicine_referral": "Zalmoxis;Cinqaero;Docetaxel SUN;Kyndrisa;Arikayce;Alendronic Acid / Colecalciferol Mylan;Keytruda;Zontivity;Ryzodeg;RoActemra;Nevanac;Ilaris;Cervarix;Arzerra;Aerivio Spiromax;Nordimet;Airexar Spiromax;Atazanavir Viatris (previously Atazanavir Mylan);Alkem;Pharmaceutics International Inc.", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/06/2016", "last_updated_date": "24/06/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-june-2016" }, { "title": "EMA and FDA reinforce collaboration on patient engagement", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/06/2016", "last_updated_date": "22/06/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-fda-reinforce-collaboration-patient-engagement" }, { "title": "EMA Management Board: highlights of June 2016 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/06/2016", "last_updated_date": "17/06/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2016-meeting" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 June 2016", "press_release": "Yes", "related_medicine_referral": "Sedadex;Metacam;Panacur AquaSol;Cardalis;Broadline;Zulvac SBV;Zulvac 1 Bovis;Zactran;Versican Plus Pi;RevitaCAM;Nobivac Myxo-RHD;Canigen L4;Nobivac L4;Nobilis Influenza H5N2;Nexgard Spectra;Melosus;Locatim (previously Serinucoli);Innovax-ILT;Eryseng Parvo;Eryseng;Equisolon;Emdocam;Trifexis", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/06/2016", "last_updated_date": "17/06/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-june-2016" }, { "title": "David Murphy elected new Chair of EMA Committee for Medicinal Products for Veterinary Use (CVMP)", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "15/06/2016", "last_updated_date": "15/06/2016", "news_url": "https://www.ema.europa.eu/en/news/david-murphy-elected-new-chair-ema-committee-medicinal-products-veterinary-use-cvmp" }, { "title": "EMA celebrates ten years of its patients and consumers working party", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/06/2016", "last_updated_date": "10/06/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-celebrates-ten-years-its-patients-consumers-working-party" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2016", "press_release": "No", "related_medicine_referral": "SGLT2 inhibitors (previously canagliflozin);Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free);Zydelig;Gadolinium-containing contrast agents", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/06/2016", "last_updated_date": "10/06/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-june-2016" }, { "title": "Single, central platform now mandatory for all periodic safety update reports", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/06/2016", "last_updated_date": "10/06/2016", "news_url": "https://www.ema.europa.eu/en/news/single-central-platform-now-mandatory-all-periodic-safety-update-reports" }, { "title": "European Medicines Agency website unavailable Saturday 11 June 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "09/06/2016", "last_updated_date": "09/06/2016", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-saturday-11-june-2016" }, { "title": "Regulation of advanced therapy medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "03/06/2016", "last_updated_date": "03/06/2016", "news_url": "https://www.ema.europa.eu/en/news/regulation-advanced-therapy-medicines" }, { "title": "Regulatory information - Management of changes to risk management plans and certain quality aspects simplified", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/06/2016", "last_updated_date": "02/06/2016", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-management-changes-risk-management-plans-certain-quality-aspects-simplified" }, { "title": "First statistics on PRIME are released", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "01/06/2016", "last_updated_date": "01/06/2016", "news_url": "https://www.ema.europa.eu/en/news/first-statistics-prime-are-released" }, { "title": "Regulatory information – A new operating model for procedure management to improve support for evaluation procedures", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/06/2016", "last_updated_date": "01/06/2016", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-new-operating-model-procedure-management-improve-support-evaluation-procedures" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016", "press_release": "No", "related_medicine_referral": "Bortezomib Hospira;Bortezomib Sun;Sialanar;Xegafri;Tysabri;Simponi;Revestive;Kyprolis;Humira;Adcetris;Ninlaro;Zepatier;Qtern;Pemetrexed Fresenius Kabi;Epclusa;Levonelle 1500 microgram tablets and associated names", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/05/2016", "last_updated_date": "27/05/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-may-2016" }, { "title": "Two new combination therapies against chronic hepatitis C", "press_release": "Yes", "related_medicine_referral": "Epclusa;Zepatier", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/05/2016", "last_updated_date": "27/05/2016", "news_url": "https://www.ema.europa.eu/en/news/two-new-combination-therapies-against-chronic-hepatitis-c" }, { "title": "Improving safety of first-in-human clinical trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/05/2016", "last_updated_date": "27/05/2016", "news_url": "https://www.ema.europa.eu/en/news/improving-safety-first-human-clinical-trials" }, { "title": "European expert group proposes reduction of use in animals of last resort antibiotic colistin to manage risk of resistance", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/05/2016", "last_updated_date": "26/05/2016", "news_url": "https://www.ema.europa.eu/en/news/european-expert-group-proposes-reduction-use-animals-last-resort-antibiotic-colistin-manage-risk-resistance" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 May 2016", "press_release": "Yes", "related_medicine_referral": "Draxxin;Zulvac 8 Ovis;Zulvac 8 Bovis;Versican Plus Pi/L4R;Versican Plus Pi;Vectra Felis;Vectra 3D;Trifexis;Porcilis PCV ID;Nobilis OR Inac;Contacera;Cerenia;Recocam;Veraflox", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/05/2016", "last_updated_date": "20/05/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-17-19-may-2016" }, { "title": "Accessing key EMA information on human medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/05/2016", "last_updated_date": "20/05/2016", "news_url": "https://www.ema.europa.eu/en/news/accessing-key-ema-information-human-medicines" }, { "title": "Progress in science, medicine and health", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/05/2016", "last_updated_date": "17/05/2016", "news_url": "https://www.ema.europa.eu/en/news/progress-science-medicine-health" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May 2016", "press_release": "No", "related_medicine_referral": "Advate;ReFacto AF;Kogenate Bayer;Helixate NexGen;Zydelig;SGLT2 inhibitors (previously canagliflozin);Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free);Gadolinium-containing contrast agents;Kogenate Bayer and Helixate NexGen", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/05/2016", "last_updated_date": "13/05/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-may-2016" }, { "title": "European Medicines Agency closed 16 May 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "13/05/2016", "last_updated_date": "13/05/2016", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-16-may-2016" }, { "title": "Can regulators influence the affordability of medicines?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/05/2016", "last_updated_date": "12/05/2016", "news_url": "https://www.ema.europa.eu/en/news/can-regulators-influence-affordability-medicines" }, { "title": "Supporting innovative SMEs as major drivers of new pharmaceutical developments", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Innovation;SME", "news_summary": "", "first_published_date": "11/05/2016", "last_updated_date": "11/05/2016", "news_url": "https://www.ema.europa.eu/en/news/supporting-innovative-smes-major-drivers-new-pharmaceutical-developments" }, { "title": "European Medicines Agency closed 5-9 May 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/05/2016", "last_updated_date": "03/05/2016", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-5-9-may-2016" }, { "title": "New treatment for rare white blood cell cancer", "press_release": "Yes", "related_medicine_referral": "Gazyvaro", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/04/2016", "last_updated_date": "29/04/2016", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-rare-white-blood-cell-cancer" }, { "title": "EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease", "press_release": "Yes", "related_medicine_referral": "Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/04/2016", "last_updated_date": "29/04/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-completes-review-inhaled-corticosteroids-chronic-obstructive-pulmonary-disease" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016", "press_release": "No", "related_medicine_referral": "EndolucinBeta;Enzepi;Zinforo;Victoza;Imbruvica;HyQvia;Gazyvaro;Ferriprox;Avastin;Reyataz;Afinitor;Praluent;Zinbryta;Zavicefta;Ongentys;Odefsey;Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease;Semler", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/04/2016", "last_updated_date": "29/04/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-28-april-2016" }, { "title": "New medicine to help in the fight against antimicrobial resistance", "press_release": "Yes", "related_medicine_referral": "Zavicefta", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/04/2016", "last_updated_date": "29/04/2016", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-help-fight-against-antimicrobial-resistance" }, { "title": "Boosting care for newborn babies in low-income countries", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/04/2016", "last_updated_date": "29/04/2016", "news_url": "https://www.ema.europa.eu/en/news/boosting-care-newborn-babies-low-income-countries" }, { "title": "Involving general practitioners in regulatory decisions on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/04/2016", "last_updated_date": "28/04/2016", "news_url": "https://www.ema.europa.eu/en/news/involving-general-practitioners-regulatory-decisions-medicines" }, { "title": "First DNA vaccine in the EU recommended for use in salmon", "press_release": "Yes", "related_medicine_referral": "Clynav", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "22/04/2016", "last_updated_date": "22/04/2016", "news_url": "https://www.ema.europa.eu/en/news/first-dna-vaccine-eu-recommended-use-salmon" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 April 2016", "press_release": "Yes", "related_medicine_referral": "Metacam;Aivlosin;Clynav;Sevohale (previously Sevocalm);Oxyglobin;SevoFlo;Equilis Prequenza Te;Equilis Prequenza;Zuprevo;Poulvac E. coli;Panacur AquaSol;BTVPUR;BTVPUR AlSap 1;Versican Plus DHPPi/L4;UpCard;Sileo;Bovela;Apoquel;Nobivac Myxo-RHD;Emdocam;Aftovaxpur DOE;Versican Plus DHPPi/L4R;Versican Plus Pi/L4R;Nobilis Influenza H5N2", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "22/04/2016", "last_updated_date": "22/04/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-april-2016" }, { "title": "Integrating patients' views in clinical studies of anticancer medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/04/2016", "last_updated_date": "22/04/2016", "news_url": "https://www.ema.europa.eu/en/news/integrating-patients-views-clinical-studies-anticancer-medicines" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2016", "press_release": "No", "related_medicine_referral": "Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free);Zydelig;SGLT2 inhibitors (previously canagliflozin);Gadolinium-containing contrast agents", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "15/04/2016", "last_updated_date": "15/04/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-april-2016" }, { "title": "Listening to the public's views on the safety of medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "15/04/2016", "last_updated_date": "15/04/2016", "news_url": "https://www.ema.europa.eu/en/news/listening-publics-views-safety-medicines" }, { "title": "Promoting high-quality clinical research to develop more and better medicines for children", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "14/04/2016", "last_updated_date": "14/04/2016", "news_url": "https://www.ema.europa.eu/en/news/promoting-high-quality-clinical-research-develop-more-better-medicines-children" }, { "title": "Cooperation between regulators and HTA bodies creates synergies", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/04/2016", "last_updated_date": "14/04/2016", "news_url": "https://www.ema.europa.eu/en/news/cooperation-between-regulators-hta-bodies-creates-synergies" }, { "title": "European Medicines Agency IT systems unavailable from 16 April to 17 April 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "11/04/2016", "last_updated_date": "11/04/2016", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-it-systems-unavailable-16-april-17-april-2016" }, { "title": "Collecting high-quality data on antibiotic use in animals in support of the fight against antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/04/2016", "last_updated_date": "07/04/2016", "news_url": "https://www.ema.europa.eu/en/news/collecting-high-quality-data-antibiotic-use-animals-support-fight-against-antimicrobial-resistance" }, { "title": "Extrapolation of data from adults to children can facilitate development of paediatric medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "04/04/2016", "last_updated_date": "04/04/2016", "news_url": "https://www.ema.europa.eu/en/news/extrapolation-data-adults-children-can-facilitate-development-paediatric-medicines" }, { "title": "Better safety for patients through EU-funded research", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/04/2016", "last_updated_date": "04/04/2016", "news_url": "https://www.ema.europa.eu/en/news/better-safety-patients-through-eu-funded-research" }, { "title": "Regulatory information - EU recommendations for composition of 2016/2017 seasonal influenza vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/04/2016", "last_updated_date": "04/04/2016", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-eu-recommendations-composition-2016-2017-seasonal-influenza-vaccines" }, { "title": "New gene therapy for the treatment of children with ultra-rare immune disorder recommended for approval", "press_release": "Yes", "related_medicine_referral": "Strimvelis", "categories": "Human", "topics": "Advanced therapies;Paediatrics", "news_summary": "", "first_published_date": "01/04/2016", "last_updated_date": "01/04/2016", "news_url": "https://www.ema.europa.eu/en/news/new-gene-therapy-treatment-children-ultra-rare-immune-disorder-recommended-approval" }, { "title": "New treatment for patients with multiple myeloma", "press_release": "Yes", "related_medicine_referral": "Darzalex", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/04/2016", "last_updated_date": "01/04/2016", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-patients-multiple-myeloma" }, { "title": "First oral treatment for Fabry disease recommended for approval in the EU", "press_release": "Yes", "related_medicine_referral": "Galafold", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/04/2016", "last_updated_date": "01/04/2016", "news_url": "https://www.ema.europa.eu/en/news/first-oral-treatment-fabry-disease-recommended-approval-eu" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 29 March - 1 April 2016", "press_release": "No", "related_medicine_referral": "Opdivo;Uptravi;Entresto;Trevicta (previously Paliperidone Janssen);Strimvelis;Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune);Dropcys;Palonosetron Accord;Neparvis;Galafold;Flixabi;Darzalex;Humira;Halaven;Vancomycin-containing medicines;Alkem;Symbioflor 2", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/04/2016", "last_updated_date": "01/04/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-29-march-1-april-2016" }, { "title": "CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections", "press_release": "Yes", "related_medicine_referral": "Fusafungine containing medicinal products for oromucosal and nasal use", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/04/2016", "last_updated_date": "01/04/2016", "news_url": "https://www.ema.europa.eu/en/news/cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections" }, { "title": "Regulatory information - adjusted fees for applications to EMA from 1 April 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/04/2016", "last_updated_date": "01/04/2016", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2016" }, { "title": "Early dialogue with regulators and HTA bodies", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/03/2016", "last_updated_date": "31/03/2016", "news_url": "https://www.ema.europa.eu/en/news/early-dialogue-regulators-hta-bodies" }, { "title": "European Medicines Agency closed 24-28 March 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/03/2016", "last_updated_date": "22/03/2016", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-24-28-march-2016" }, { "title": "European Medicines Agency IT systems unavailable from 16 April to 17 April 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "21/03/2016", "last_updated_date": "21/03/2016", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-it-systems-unavailable-16-april-17-april-2016-0" }, { "title": "EMA Management Board: highlights of March 2016 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/03/2016", "last_updated_date": "21/03/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2016-meeting" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 15-17 March 2016", "press_release": "Yes", "related_medicine_referral": "Bravecto;Profender;Virbagen Omega;Versican Plus DHPPi/L4R;ProteqFlu-Te;ProteqFlu;Procox;Porcilis PCV M Hyo;Porcilis ColiClos;Pexion;Parvoduk;Oncept IL-2;Meloxidolor;Equip WNV (previously Duvaxyn WNV);Dicural;Certifect;BTVPUR AlSap 2-4;Proteq West Nile;MS-H Vaccine;Aftovaxpur DOE", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/03/2016", "last_updated_date": "18/03/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-15-17-march-2016" }, { "title": "PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease", "press_release": "Yes", "related_medicine_referral": "Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "18/03/2016", "last_updated_date": "18/03/2016", "news_url": "https://www.ema.europa.eu/en/news/prac-reviews-known-risk-pneumonia-inhaled-corticosteroids-chronic-obstructive-pulmonary-disease" }, { "title": "EMA recommends new safety measures for Zydelig", "press_release": "Yes", "related_medicine_referral": "Zydelig;Zydelig", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "18/03/2016", "last_updated_date": "18/03/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-new-safety-measures-zydelig" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016", "press_release": "No", "related_medicine_referral": "Zydelig;Zydelig;Gadolinium-containing contrast agents;Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease;Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "18/03/2016", "last_updated_date": "18/03/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-14-17-march-2016" }, { "title": "EMA Management Board elects Christa Wirthumer-Hoche as chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/03/2016", "last_updated_date": "17/03/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-elects-christa-wirthumer-hoche-chair" }, { "title": "EMA reviews cancer medicine Zydelig", "press_release": "Yes", "related_medicine_referral": "Zydelig;Zydelig", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/03/2016", "last_updated_date": "11/03/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-reviews-cancer-medicine-zydelig" }, { "title": "Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "09/03/2016", "last_updated_date": "09/03/2016", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-european-medicines-agency-1-april-2016" }, { "title": "Launch of PRIME - Paving the way for promising medicines for patients", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "07/03/2016", "last_updated_date": "07/03/2016", "news_url": "https://www.ema.europa.eu/en/news/launch-prime-paving-way-promising-medicines-patients" }, { "title": "Facilitating development of medicines for autism spectrum disorder", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/03/2016", "last_updated_date": "04/03/2016", "news_url": "https://www.ema.europa.eu/en/news/facilitating-development-medicines-autism-spectrum-disorder" }, { "title": "Novel veterinary medicines – how to make use of stem cells and monoclonal antibodies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "03/03/2016", "last_updated_date": "03/03/2016", "news_url": "https://www.ema.europa.eu/en/news/novel-veterinary-medicines-how-make-use-stem-cells-monoclonal-antibodies" }, { "title": "Guidance for the publication of clinical data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "03/03/2016", "last_updated_date": "03/03/2016", "news_url": "https://www.ema.europa.eu/en/news/guidance-publication-clinical-data" }, { "title": "EMA welcomes Italy's Minister of Health Beatrice Lorenzin", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/03/2016", "last_updated_date": "01/03/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-welcomes-italys-minister-health-beatrice-lorenzin" }, { "title": "Improving patient safety through more proactive risk management", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/02/2016", "last_updated_date": "29/02/2016", "news_url": "https://www.ema.europa.eu/en/news/improving-patient-safety-through-more-proactive-risk-management" }, { "title": "New treatment for advanced form of kidney cancer", "press_release": "Yes", "related_medicine_referral": "Opdivo", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/02/2016", "last_updated_date": "26/02/2016", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-advanced-form-kidney-cancer" }, { "title": "EMA confirms recommendations to minimise risk of brain infection PML with Tysabri", "press_release": "Yes", "related_medicine_referral": "Tysabri;Tysabri", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/02/2016", "last_updated_date": "26/02/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-recommendations-minimise-risk-brain-infection-pml-tysabri" }, { "title": "EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes", "press_release": "Yes", "related_medicine_referral": "SGLT2 inhibitors", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/02/2016", "last_updated_date": "26/02/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-recommendations-minimise-ketoacidosis-risk-sglt2-inhibitors-diabetes" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2016", "press_release": "No", "related_medicine_referral": "Alprolix;Descovy;Telzir;Zydelig;TachoSil;Ruconest;Opdivo;Humira;Giotrif;Ferriprox;Palonosetron Hospira;Taltz;Lonsurf;Idelvion;SGLT2 inhibitors;Tysabri;Dienogest/ethinylestradiol-containing medicinal products indicated in acne;Cymevene", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/02/2016", "last_updated_date": "26/02/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-february-2016" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 16-18 February 2016", "press_release": "Yes", "related_medicine_referral": "Evalon;Bravecto;Letifend;Fungitraxx;Recocam;Zulvac 1+8 Bovis;Coliprotec F4;Equisolon;Comfortis;CaniLeish;Aivlosin;Zulvac 1 Ovis;Zulvac 1 Bovis;Certifect;Draxxin;BTVPUR", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/02/2016", "last_updated_date": "19/02/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-16-18-february-2016" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2016", "press_release": "No", "related_medicine_referral": "Tysabri;Fusafungine containing medicinal products for oromucosal and nasal use;SGLT2 inhibitors", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/02/2016", "last_updated_date": "12/02/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-february-2016" }, { "title": "Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri", "press_release": "Yes", "related_medicine_referral": "Tysabri;Tysabri", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "12/02/2016", "last_updated_date": "12/02/2016", "news_url": "https://www.ema.europa.eu/en/news/updated-recommendations-minimise-risk-rare-brain-infection-pml-tysabri" }, { "title": "PRAC recommends that fusafungine nose and mouth sprays are no longer marketed", "press_release": "Yes", "related_medicine_referral": "Fusafungine containing medicinal products for oromucosal and nasal use", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "12/02/2016", "last_updated_date": "12/02/2016", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-fusafungine-nose-mouth-sprays-are-no-longer-marketed" }, { "title": "SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis", "press_release": "Yes", "related_medicine_referral": "Forxiga;Edistride;Ebymect;Xigduo;Vokanamet;Synjardy;Jardiance;Invokana;SGLT2 inhibitors", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "12/02/2016", "last_updated_date": "12/02/2016", "news_url": "https://www.ema.europa.eu/en/news/sglt2-inhibitors-prac-makes-recommendations-minimise-risk-diabetic-ketoacidosis" }, { "title": "Measures to help protect patients from falsified medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/02/2016", "last_updated_date": "09/02/2016", "news_url": "https://www.ema.europa.eu/en/news/measures-help-protect-patients-falsified-medicines" }, { "title": "EMA sets up task force on Zika virus", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/02/2016", "last_updated_date": "08/02/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-sets-task-force-zika-virus" }, { "title": "EMA concludes defective device in ROCKET study does not impact Xarelto's safety", "press_release": "No", "related_medicine_referral": "Xarelto", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "05/02/2016", "last_updated_date": "05/02/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-concludes-defective-device-rocket-study-does-not-impact-xareltos-safety" }, { "title": "How to facilitate development of cancer immunotherapies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/02/2016", "last_updated_date": "02/02/2016", "news_url": "https://www.ema.europa.eu/en/news/how-facilitate-development-cancer-immunotherapies" }, { "title": "Consultation on revised guideline on medicines to treat Alzheimer's disease", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "01/02/2016", "last_updated_date": "01/02/2016", "news_url": "https://www.ema.europa.eu/en/news/consultation-revised-guideline-medicines-treat-alzheimers-disease" }, { "title": "EMA fast-tracks treatment of multiple myeloma for approval in EU", "press_release": "Yes", "related_medicine_referral": "Empliciti", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/01/2016", "last_updated_date": "29/01/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-fast-tracks-treatment-multiple-myeloma-approval-eu" }, { "title": "First specific replacement therapy to treat rare bleeding disorder", "press_release": "Yes", "related_medicine_referral": "Coagadex", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/01/2016", "last_updated_date": "29/01/2016", "news_url": "https://www.ema.europa.eu/en/news/first-specific-replacement-therapy-treat-rare-bleeding-disorder" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 2016", "press_release": "No", "related_medicine_referral": "Aripiprazole Mylan;Dropcys;Revolade;Coagadex;Empliciti;Uptravi;Amlodipine / Valsartan Mylan;Rasagiline Viatris (previously Rasagiline Mylan);Zonisamide Viatris (previously Zonisamide Mylan);Revlimid;Tobramycin VVB and associated names;Metformin and metformin-containing medicines", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/01/2016", "last_updated_date": "29/01/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-28-january-2016" }, { "title": "Veterinary medicines: highlights of 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "27/01/2016", "last_updated_date": "27/01/2016", "news_url": "https://www.ema.europa.eu/en/news/veterinary-medicines-highlights-2015" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 January 2016", "press_release": "Yes", "related_medicine_referral": "Panacur AquaSol;Zuprevo;Zolvix;Profender;Nobivac L4;Kexxtone;Zulvac SBV;Semintra;Nobilis IB Primo QX;NexGard;Ingelvac CircoFLEX;Econor;Bravecto;Bovilis BTV8;Activyl;Nobilis IB 4-91", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "22/01/2016", "last_updated_date": "22/01/2016", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-january-2016" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2016", "press_release": "No", "related_medicine_referral": "Tysabri;Fusafungine containing medicinal products for oromucosal and nasal use;SGLT2 inhibitors;Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "15/01/2016", "last_updated_date": "15/01/2016", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-january-2016" }, { "title": "Handling competing interests: revised rules for Management Board members", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/01/2016", "last_updated_date": "14/01/2016", "news_url": "https://www.ema.europa.eu/en/news/handling-competing-interests-revised-rules-management-board-members" }, { "title": "Human medicines: highlights of 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "12/01/2016", "last_updated_date": "12/01/2016", "news_url": "https://www.ema.europa.eu/en/news/human-medicines-highlights-2015" }, { "title": "EMA advice on use of colistin in animals to be updated", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/01/2016", "last_updated_date": "11/01/2016", "news_url": "https://www.ema.europa.eu/en/news/ema-advice-use-colistin-animals-be-updated" }, { "title": "“Our commitment to patients' welfare will continue to guide our work in 2016”", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/12/2015", "last_updated_date": "21/12/2015", "news_url": "https://www.ema.europa.eu/en/news/our-commitment-patients-welfare-will-continue-guide-our-work-2016" }, { "title": "European Medicines Agency closed 23 December 2015 to 3 January 2016", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "21/12/2015", "last_updated_date": "21/12/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-23-december-2015-3-january-2016" }, { "title": "Regulatory information – Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Data on medicines", "news_summary": "", "first_published_date": "18/12/2015", "last_updated_date": "18/12/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-green-light-reliance-article-57-database-key-pharmacovigilance-information-medicines-human-use-europe" }, { "title": "Shaping the future of human and animal health in the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/12/2015", "last_updated_date": "18/12/2015", "news_url": "https://www.ema.europa.eu/en/news/shaping-future-human-animal-health-eu" }, { "title": "Increasing access to reports on adverse reactions to medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/12/2015", "last_updated_date": "18/12/2015", "news_url": "https://www.ema.europa.eu/en/news/increasing-access-reports-adverse-reactions-medicines" }, { "title": "EMA Management Board: highlights of December 2015 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/12/2015", "last_updated_date": "18/12/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2015-meeting" }, { "title": "EMA fast-tracks new oral treatment for non-small cell lung cancer", "press_release": "Yes", "related_medicine_referral": "Tagrisso", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "18/12/2015", "last_updated_date": "18/12/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-fast-tracks-new-oral-treatment-non-small-cell-lung-cancer" }, { "title": "New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya", "press_release": "Yes", "related_medicine_referral": "Gilenya", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "18/12/2015", "last_updated_date": "18/12/2015", "news_url": "https://www.ema.europa.eu/en/news/new-recommendations-minimise-risks-rare-brain-infection-pml-type-skin-cancer-gilenya" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 December 2015", "press_release": "No", "related_medicine_referral": "Zurampic;Vaxelis;Xarelto;Tarceva;Nplate;Revolade;Gilenya;Cyramza;Caspofungin Accord;Dropcys;Feraccru;Kovaltry;Portrazza;Iblias;Neofordex;Tagrisso", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "18/12/2015", "last_updated_date": "18/12/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-december-2015" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 December 2015", "press_release": "Yes", "related_medicine_referral": "Zactran;Advocate;Suvaxyn PCV;Rheumocam;Reconcile;Versican Plus L4;Vectra 3D;ProZinc;Nexgard Spectra;Ecoporc Shiga;Cimalgex;Bluevac BTV (previously Bluevac BTV8);Versican Plus Pi/L4;Versican Plus Pi;Versican Plus Pi/L4R;Versican Plus DHPPi/L4R;Versican Plus DHPPi/L4;Versican Plus DHPPi;Porcilis PCV M Hyo;Bravecto", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/12/2015", "last_updated_date": "11/12/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-december-2015" }, { "title": "“EMA ready to address challenges ahead”", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/12/2015", "last_updated_date": "10/12/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-ready-address-challenges-ahead" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 November - 3 December 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "04/12/2015", "last_updated_date": "04/12/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-30-november-3-december-2015" }, { "title": "Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "30/11/2015", "last_updated_date": "30/11/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-replacement-gcp-non-compliant-pivotal-studies-centralised-marketing-authorisation-applications-not-accepted" }, { "title": "Safer use of medicines by preventing medication errors", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/11/2015", "last_updated_date": "27/11/2015", "news_url": "https://www.ema.europa.eu/en/news/safer-use-medicines-preventing-medication-errors" }, { "title": "Regulatory information - EMA encourages companies to submit type I variations and transfer of marketing authorisation applications for 2015 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/11/2015", "last_updated_date": "24/11/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-encourages-companies-submit-type-i-variations-transfer-marketing-authorisation-applications-2015-end-november" }, { "title": "Narcolepsy treatment recommended for approval", "press_release": "Yes", "related_medicine_referral": "Wakix", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/11/2015", "last_updated_date": "20/11/2015", "news_url": "https://www.ema.europa.eu/en/news/narcolepsy-treatment-recommended-approval" }, { "title": "HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS", "press_release": "Yes", "related_medicine_referral": "Cervarix;Gardasil;Silgard;Gardasil 9;Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/11/2015", "last_updated_date": "20/11/2015", "news_url": "https://www.ema.europa.eu/en/news/hpv-vaccines-ema-confirms-evidence-does-not-support-they-cause-crps-or-pots" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015", "press_release": "No", "related_medicine_referral": "Feraccru;Benepali;Zutectra;Cimzia;Solumarv;Wakix;Spectrila;Armisarte (previously Pemetrexed Actavis);Pemetrexed Accord;Oncaspar;Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan);Eptifibatide Accord;Episalvan;Briviact (in Italy: Nubriveo);Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "20/11/2015", "last_updated_date": "20/11/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-november-2015" }, { "title": "European Antibiotic Awareness Day 2015", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/11/2015", "last_updated_date": "17/11/2015", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-2015" }, { "title": "New strategy to fight antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/11/2015", "last_updated_date": "17/11/2015", "news_url": "https://www.ema.europa.eu/en/news/new-strategy-fight-antimicrobial-resistance" }, { "title": "Committee for Orphan Medicinal Products: November 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "17/11/2015", "last_updated_date": "17/11/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-november-2004-meeting" }, { "title": "Guido Rasi takes office as head of EMA", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/11/2015", "last_updated_date": "16/11/2015", "news_url": "https://www.ema.europa.eu/en/news/guido-rasi-takes-office-head-ema" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 November 2015", "press_release": "Yes", "related_medicine_referral": "Activyl;Vectormune ND;Versican Plus Pi/L4;Versican Plus Pi/L4R;Versican Plus Pi;Versican Plus DHPPi;Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli);Eryseng;RevitaCAM;Trifexis;Inflacam;Eryseng Parvo;Certifect;Hiprabovis IBR Marker Live;Zulvac 8 Ovis;Zulvac 8 Bovis;Prac-tic;Cerenia;Broadline;Acticam;Zulvac 1+8 Ovis;Veraflox;Procox;Melosus;Comfortis;Cimalgex;CaniLeish", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/11/2015", "last_updated_date": "09/11/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-4-6-november-2015" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-5 November 2015", "press_release": "No", "related_medicine_referral": "Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard;Fusafungine containing medicinal products for oromucosal and nasal use;SGLT2 inhibitors;Tysabri;Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "06/11/2015", "last_updated_date": "06/11/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-5-november-2015" }, { "title": "Supporting better use of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/11/2015", "last_updated_date": "06/11/2015", "news_url": "https://www.ema.europa.eu/en/news/supporting-better-use-medicines" }, { "title": "Review concludes evidence does not support that HPV vaccines cause CRPS or POTS", "press_release": "Yes", "related_medicine_referral": "Gardasil;Cervarix;Gardasil 9;Silgard;Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "05/11/2015", "last_updated_date": "05/11/2015", "news_url": "https://www.ema.europa.eu/en/news/review-concludes-evidence-does-not-support-hpv-vaccines-cause-crps-or-pots" }, { "title": "European Medicines Agency closed 2 November 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/10/2015", "last_updated_date": "29/10/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-2-november-2015" }, { "title": "Improved electronic reporting of suspected adverse reactions for better health protection", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/10/2015", "last_updated_date": "27/10/2015", "news_url": "https://www.ema.europa.eu/en/news/improved-electronic-reporting-suspected-adverse-reactions-better-health-protection" }, { "title": "How to improve product lifecycle management", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/10/2015", "last_updated_date": "26/10/2015", "news_url": "https://www.ema.europa.eu/en/news/how-improve-product-lifecycle-management" }, { "title": "Public consultation starts on PRIME - a new scheme to optimise development of priority medicines and facilitate patients' access", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "26/10/2015", "last_updated_date": "26/10/2015", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-starts-prime-new-scheme-optimise-development-priority-medicines-facilitate-patients-access" }, { "title": "First oncolytic immunotherapy medicine recommended for approval", "press_release": "Yes", "related_medicine_referral": "Imlygic", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2015", "last_updated_date": "23/10/2015", "news_url": "https://www.ema.europa.eu/en/news/first-oncolytic-immunotherapy-medicine-recommended-approval" }, { "title": "Inductos to be suspended in the EU", "press_release": "Yes", "related_medicine_referral": "Inductos", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2015", "last_updated_date": "23/10/2015", "news_url": "https://www.ema.europa.eu/en/news/inductos-be-suspended-eu" }, { "title": "EMA recommends additional measures to prevent use of mycophenolate in pregnancy", "press_release": "Yes", "related_medicine_referral": "CellCept", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2015", "last_updated_date": "23/10/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-additional-measures-prevent-use-mycophenolate-pregnancy" }, { "title": "Updated recommendations to minimise the risk of the rare brain infection PML with Tecfidera", "press_release": "Yes", "related_medicine_referral": "Tecfidera", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2015", "last_updated_date": "23/10/2015", "news_url": "https://www.ema.europa.eu/en/news/updated-recommendations-minimise-risk-rare-brain-infection-pml-tecfidera" }, { "title": "Updated advice on body fat changes and lactic acidosis with HIV medicines", "press_release": "Yes", "related_medicine_referral": "Epivir;Stribild;Eviplera;Edurant;Intelence;Atripla;Prezista;Aptivus;Truvada;Kivexa;Telzir;Emtriva;Reyataz;Viread;Kaletra;Trizivir;Ziagen;Stocrin;Sustiva;Combivir;Viramune;Crixivan;Norvir;Invirase;Zerit", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2015", "last_updated_date": "23/10/2015", "news_url": "https://www.ema.europa.eu/en/news/updated-advice-body-fat-changes-lactic-acidosis-hiv-medicines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 2015", "press_release": "No", "related_medicine_referral": "Imlygic;Heparesc;Veraseal;Emend;Stribild;Eviplera;Edurant;Intelence;Atripla;Prezista;Aptivus;Truvada;Kivexa;Telzir;Emtriva;Reyataz;Viread;Kaletra;Trizivir;Ziagen;Stocrin;Sustiva;Combivir;Viramune;Crixivan;Norvir;Invirase;Zerit;Epivir;CellCept;Tecfidera;Xalkori;Volibris;Edurant;Cubicin;Cosentyx;Inductos;Inductos", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2015", "last_updated_date": "23/10/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-october-2015" }, { "title": "IT systems unavailable from 30 October to 3 November 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/10/2015", "last_updated_date": "23/10/2015", "news_url": "https://www.ema.europa.eu/en/news/it-systems-unavailable-30-october-3-november-2015" }, { "title": "Regulatory update - EMA encourages companies to submit type I variations for 2015 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/10/2015", "last_updated_date": "23/10/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2015-end-november" }, { "title": "Can measuring anticoagulant activity and concentration in the body play a role in clinical use of medicines used to prevent blood clots?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/10/2015", "last_updated_date": "16/10/2015", "news_url": "https://www.ema.europa.eu/en/news/can-measuring-anticoagulant-activity-concentration-body-play-role-clinical-use-medicines-used-prevent-blood-clots" }, { "title": "Supporting responsible use of veterinary antibiotics in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/10/2015", "last_updated_date": "15/10/2015", "news_url": "https://www.ema.europa.eu/en/news/supporting-responsible-use-veterinary-antibiotics-europe" }, { "title": "Collecting high-quality information on medicines through patient registries", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/10/2015", "last_updated_date": "12/10/2015", "news_url": "https://www.ema.europa.eu/en/news/collecting-high-quality-information-medicines-through-patient-registries" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 October 2015", "press_release": "Yes", "related_medicine_referral": "Velactis;Vectra Felis;Panacur AquaSol;Oncept IL-2;MS-H Vaccine;Meloxivet;Fevaxyn Pentofel;Equip WNV (previously Duvaxyn WNV);Contacera;BTVPUR AlSap 2-4;Bovela;Apoquel;Purevax Rabies;Purevax RCPCh FeLV;Purevax RCPCh;Bovalto Ibraxion;Vaxxitek HVT+IBD;Hiprabovis IBR Marker Live;Inflacam;Imrestor", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/10/2015", "last_updated_date": "09/10/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-october-2015" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 October 2015", "press_release": "No", "related_medicine_referral": "SGLT2 inhibitors;Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard;Tysabri", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "09/10/2015", "last_updated_date": "09/10/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-october-2015" }, { "title": "Committee for Orphan Medicinal Products: October 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/10/2015", "last_updated_date": "08/10/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-october-2004-meeting" }, { "title": "Committee for Orphan Medicinal Products: Chair and Vice-chair re-elected", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/10/2015", "last_updated_date": "07/10/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-chair-vice-chair-re-elected" }, { "title": "EMA Management Board: highlights of October 2015 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/10/2015", "last_updated_date": "06/10/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2015-meeting" }, { "title": "European Medicines Agency IT systems unavailable from 30 October to 3 November 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "05/10/2015", "last_updated_date": "05/10/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-it-systems-unavailable-30-october-3-november-2015" }, { "title": "European Medicines Agency's Management Board nominates Guido Rasi as Executive Director", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/10/2015", "last_updated_date": "01/10/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-nominates-guido-rasi-executive-director" }, { "title": "Call for civil society members to join two EMA committees", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/09/2015", "last_updated_date": "30/09/2015", "news_url": "https://www.ema.europa.eu/en/news/call-civil-society-members-join-two-ema-committees" }, { "title": "Management Board expected to nominate EMA Executive Director on 1 October 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/09/2015", "last_updated_date": "29/09/2015", "news_url": "https://www.ema.europa.eu/en/news/management-board-expected-nominate-ema-executive-director-1-october-2015" }, { "title": "New guidance to speed up development of antibiotics", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/09/2015", "last_updated_date": "28/09/2015", "news_url": "https://www.ema.europa.eu/en/news/new-guidance-speed-development-antibiotics" }, { "title": "EMA fast-tracks antidote to anticoagulant Pradaxa", "press_release": "Yes", "related_medicine_referral": "Praxbind", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/09/2015", "last_updated_date": "25/09/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-fast-tracks-antidote-anticoagulant-pradaxa" }, { "title": "New medicine to treat heart failure recommended for approval", "press_release": "Yes", "related_medicine_referral": "Entresto", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/09/2015", "last_updated_date": "25/09/2015", "news_url": "https://www.ema.europa.eu/en/news/new-medicine-treat-heart-failure-recommended-approval" }, { "title": "New treatment option for patients with rare blood cancer", "press_release": "Yes", "related_medicine_referral": "Kyprolis", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/09/2015", "last_updated_date": "25/09/2015", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-option-patients-rare-blood-cancer" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015", "press_release": "No", "related_medicine_referral": "Rebetol;Vidaza;Kolbam;Ciambra;Pemetrexed medac;Pemetrexed Pfizer (previously Pemetrexed Hospira);Cinacalcet Viatris (previously Cinacalcet Mylan);Aripiprazole Accord;Entresto;Edistride;Ebymect;Ravicti;Praxbind;Orkambi;Nucala;Numient;Kyprolis;Ionsys;Genvoya;Cotellic;Blincyto;Opdivo;Kalydeco;Eylea;Gilenya", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/09/2015", "last_updated_date": "25/09/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-september-2015" }, { "title": "Update on publication of clinical data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/09/2015", "last_updated_date": "22/09/2015", "news_url": "https://www.ema.europa.eu/en/news/update-publication-clinical-data-0" }, { "title": "European Commission, European Medicines Agency and World Health Organization step up cooperation to better protect global public health", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/09/2015", "last_updated_date": "22/09/2015", "news_url": "https://www.ema.europa.eu/en/news/european-commission-european-medicines-agency-world-health-organization-step-cooperation-better-protect-global-public-health" }, { "title": "CHMP Chair re-elected", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/09/2015", "last_updated_date": "21/09/2015", "news_url": "https://www.ema.europa.eu/en/news/chmp-chair-re-elected" }, { "title": "Committee for Orphan Medicinal Products: September 2004 Meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "14/09/2015", "last_updated_date": "14/09/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-september-2004-meeting" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 September 2015", "press_release": "Yes", "related_medicine_referral": "Simparica;Suvaxyn Circo+MH RTU;Recuvyra;Porcilis PCV M Hyo;Parvoduk;Nobilis IB 4-91;Meloxoral;Meloxidolor;Fungitraxx;Hiprabovis IBR Marker Live;Versican Plus Pi;Versican Plus DHPPi;Versican Plus DHPPi/L4;Versican Plus Pi/L4;Versican Plus Pi/L4R;Versican Plus DHPPi/L4R;Nexgard Spectra;NexGard;Purevax RCPCh;Purevax RCPCh FeLV;Circovac;Bovalto Ibraxion;Zulvac SBV;Startvac;SevoFlo;Respiporc Flu3;Ingelvac CircoFLEX;Gripovac 3;Eurican Herpes 205;Aivlosin;Zycortal", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/09/2015", "last_updated_date": "11/09/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-september-2015" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 September 2015", "press_release": "No", "related_medicine_referral": "Fusafungine containing medicinal products for oromucosal and nasal use", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "11/09/2015", "last_updated_date": "11/09/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-september-2015" }, { "title": "Demonstrating significant benefit of orphan medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "04/09/2015", "last_updated_date": "04/09/2015", "news_url": "https://www.ema.europa.eu/en/news/demonstrating-significant-benefit-orphan-medicines" }, { "title": "EMA's medical literature monitoring enters into full operation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/09/2015", "last_updated_date": "01/09/2015", "news_url": "https://www.ema.europa.eu/en/news/emas-medical-literature-monitoring-enters-full-operation" }, { "title": "European Medicines Agency closed 31 August 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/08/2015", "last_updated_date": "26/08/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-31-august-2015" }, { "title": "Updated guidance on good clinical practice released for consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "21/08/2015", "last_updated_date": "21/08/2015", "news_url": "https://www.ema.europa.eu/en/news/updated-guidance-good-clinical-practice-released-consultation" }, { "title": "Making IT services for medicine regulation in Europe more efficient", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/08/2015", "last_updated_date": "11/08/2015", "news_url": "https://www.ema.europa.eu/en/news/making-it-services-medicine-regulation-europe-more-efficient" }, { "title": "Public-friendly information on herbal medicines now available", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "03/08/2015", "last_updated_date": "03/08/2015", "news_url": "https://www.ema.europa.eu/en/news/public-friendly-information-herbal-medicines-now-available" }, { "title": "Regulatory information – Rules on fees are revised", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/07/2015", "last_updated_date": "29/07/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-rules-fees-are-revised" }, { "title": "Calls for civil society members for two EMA committees", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/07/2015", "last_updated_date": "29/07/2015", "news_url": "https://www.ema.europa.eu/en/news/calls-civil-society-members-two-ema-committees" }, { "title": "EMA to encourage use of scientific advice for post-authorisation safety studies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/07/2015", "last_updated_date": "28/07/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-encourage-use-scientific-advice-post-authorisation-safety-studies" }, { "title": "Fast track routes for medicines that address unmet medical needs", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/07/2015", "last_updated_date": "27/07/2015", "news_url": "https://www.ema.europa.eu/en/news/fast-track-routes-medicines-address-unmet-medical-needs" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015", "press_release": "No", "related_medicine_referral": "Cresemba;Fexeric;Tafinlar;Revolade;Qutenza;Mekinist;Zalviso;Pemetrexed Sandoz;Pemetrexed Lilly;Ivabradine Anpharm;Obizur;Zerbaxa;Praluent;Intuniv;Inductos", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2015", "last_updated_date": "24/07/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-july-2015" }, { "title": "First malaria vaccine receives positive scientific opinion from EMA", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2015", "last_updated_date": "24/07/2015", "news_url": "https://www.ema.europa.eu/en/news/first-malaria-vaccine-receives-positive-scientific-opinion-ema" }, { "title": "Praluent recommended for approval to lower cholesterol", "press_release": "Yes", "related_medicine_referral": "Praluent", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2015", "last_updated_date": "24/07/2015", "news_url": "https://www.ema.europa.eu/en/news/praluent-recommended-approval-lower-cholesterol" }, { "title": "EMA recommends approval of treatment for attention deficit hyperactivity disorder", "press_release": "Yes", "related_medicine_referral": "Intuniv", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2015", "last_updated_date": "24/07/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-treatment-attention-deficit-hyperactivity-disorder" }, { "title": "EMA to review Inductos", "press_release": "Yes", "related_medicine_referral": "Inductos;Inductos", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2015", "last_updated_date": "24/07/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-review-inductos" }, { "title": "Stimulating the development of medicines for children", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "23/07/2015", "last_updated_date": "23/07/2015", "news_url": "https://www.ema.europa.eu/en/news/stimulating-development-medicines-children" }, { "title": "EU and Swiss regulators sign confidentiality arrangement", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/07/2015", "last_updated_date": "22/07/2015", "news_url": "https://www.ema.europa.eu/en/news/eu-swiss-regulators-sign-confidentiality-arrangement" }, { "title": "Pharmacovigilance Risk Assessment Committee confirms Chair and Vice-chair for new three year mandate", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "17/07/2015", "last_updated_date": "17/07/2015", "news_url": "https://www.ema.europa.eu/en/news/pharmacovigilance-risk-assessment-committee-confirms-chair-vice-chair-new-three-year-mandate" }, { "title": "Public register of parallel distribution now available", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/07/2015", "last_updated_date": "15/07/2015", "news_url": "https://www.ema.europa.eu/en/news/public-register-parallel-distribution-now-available" }, { "title": "Improving bioequivalence studies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/07/2015", "last_updated_date": "15/07/2015", "news_url": "https://www.ema.europa.eu/en/news/improving-bioequivalence-studies" }, { "title": "FDA, European Commission and EMA reinforce collaboration to advance medicine development and evaluation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/07/2015", "last_updated_date": "14/07/2015", "news_url": "https://www.ema.europa.eu/en/news/fda-european-commission-ema-reinforce-collaboration-advance-medicine-development-evaluation" }, { "title": "Call for civil society members of EMA Management Board", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/07/2015", "last_updated_date": "14/07/2015", "news_url": "https://www.ema.europa.eu/en/news/call-civil-society-members-ema-management-board" }, { "title": "How to improve the availability of veterinary vaccines in Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/07/2015", "last_updated_date": "13/07/2015", "news_url": "https://www.ema.europa.eu/en/news/how-improve-availability-veterinary-vaccines-europe" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2015", "press_release": "No", "related_medicine_referral": "Cervarix;Gardasil;Silgard;Gardasil 9;Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/07/2015", "last_updated_date": "13/07/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-july-2015" }, { "title": "EMA to further clarify safety profile of human papillomavirus (HPV) vaccines", "press_release": "Yes", "related_medicine_referral": "Cervarix;Silgard;Gardasil 9;Gardasil;Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "13/07/2015", "last_updated_date": "13/07/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-further-clarify-safety-profile-human-papillomavirus-hpv-vaccines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 July 2015", "press_release": "Yes", "related_medicine_referral": "Novaquin;Pexion;Nobivac L4;Semintra;Rhiniseng;RevitaCAM;NexGard;Purevax RCP FeLV;Purevax RCP;Purevax RC;Purevax Rabies;Proteq West Nile;Coxevac;Bravecto;Bovilis BTV8;Hiprabovis IBR Marker Live;Meloxoral;BTVPUR;BTVPUR AlSap 1;Suvaxyn CSF Marker;Purevax RCPCh FeLV;Purevax RCPCh;Oxyglobin;Ingelvac CircoFLEX;Hiprabovis IBR Marker Live;Advocate;Fortekor Plus;Vectormune ND;Porcilis PCV ID", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/07/2015", "last_updated_date": "10/07/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-july-2015" }, { "title": "Improving safety of medicines across Europe", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/07/2015", "last_updated_date": "06/07/2015", "news_url": "https://www.ema.europa.eu/en/news/improving-safety-medicines-across-europe" }, { "title": "Regulatory information – Mandatory use of common repository for human centralised procedures as of today", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/07/2015", "last_updated_date": "01/07/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-mandatory-use-common-repository-human-centralised-procedures-today" }, { "title": "Regulatory information - Electronic application becomes mandatory today", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/07/2015", "last_updated_date": "01/07/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-electronic-application-becomes-mandatory-today" }, { "title": "Staying safe when buying medicines online", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/07/2015", "last_updated_date": "01/07/2015", "news_url": "https://www.ema.europa.eu/en/news/staying-safe-when-buying-medicines-online" }, { "title": "Facilitating the development of advanced therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Innovation", "news_summary": "", "first_published_date": "30/06/2015", "last_updated_date": "30/06/2015", "news_url": "https://www.ema.europa.eu/en/news/facilitating-development-advanced-therapies" }, { "title": "Update on publication of clinical data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/06/2015", "last_updated_date": "29/06/2015", "news_url": "https://www.ema.europa.eu/en/news/update-publication-clinical-data" }, { "title": "EMA fast-tracks enzyme replacement therapy for lysosomal acid lipase deficiency", "press_release": "Yes", "related_medicine_referral": "Kanuma", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2015", "last_updated_date": "26/06/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-fast-tracks-enzyme-replacement-therapy-lysosomal-acid-lipase-deficiency" }, { "title": "First treatment recommended for rare bone disease", "press_release": "Yes", "related_medicine_referral": "Strensiq", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2015", "last_updated_date": "26/06/2015", "news_url": "https://www.ema.europa.eu/en/news/first-treatment-recommended-rare-bone-disease" }, { "title": "First HDAC inhibitor for treatment of multiple myeloma recommended for approval in EU", "press_release": "Yes", "related_medicine_referral": "Farydak", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2015", "last_updated_date": "26/06/2015", "news_url": "https://www.ema.europa.eu/en/news/first-hdac-inhibitor-treatment-multiple-myeloma-recommended-approval-eu" }, { "title": "First medicine recommended for approval for hidradenitis suppurativa", "press_release": "Yes", "related_medicine_referral": "Humira", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2015", "last_updated_date": "26/06/2015", "news_url": "https://www.ema.europa.eu/en/news/first-medicine-recommended-approval-hidradenitis-suppurativa" }, { "title": "Better training tools recommended to support patients using adrenaline auto-injectors", "press_release": "Yes", "related_medicine_referral": "Adrenaline auto-injectors", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2015", "last_updated_date": "26/06/2015", "news_url": "https://www.ema.europa.eu/en/news/better-training-tools-recommended-support-patients-using-adrenaline-auto-injectors" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2015", "press_release": "No", "related_medicine_referral": "Farydak;Kanuma;Respreeza;Voncento;Perjeta;Levemir;Humira;Heparesc;Raxone;Pregabalin Accord;Duloxetine Zentiva;Taxespira (previously Docetaxel Hospira UK Limited );Aripiprazole Sandoz;Strensiq;Odomzo;Adrenaline auto-injectors;Amoxil", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2015", "last_updated_date": "26/06/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-june-2015" }, { "title": "Early dialogue to support development of medicines for children", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "16/06/2015", "last_updated_date": "16/06/2015", "news_url": "https://www.ema.europa.eu/en/news/early-dialogue-support-development-medicines-children" }, { "title": "EMA Management Board: highlights of June 2015 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/06/2015", "last_updated_date": "12/06/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2015-meeting" }, { "title": "Central repository for safety reports - one year to go before mandatory use", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/06/2015", "last_updated_date": "12/06/2015", "news_url": "https://www.ema.europa.eu/en/news/central-repository-safety-reports-one-year-go-mandatory-use" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2015", "press_release": "No", "related_medicine_referral": "Invokana;Jardiance;Synjardy;Xigduo;Vokanamet;Forxiga;SGLT2 inhibitors", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/06/2015", "last_updated_date": "12/06/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-june-2015" }, { "title": "Regulatory information – Updates to product information templates for all medicines for human use", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/06/2015", "last_updated_date": "10/06/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-updates-product-information-templates-all-medicines-human-use" }, { "title": "EMA getting ready for the publication of clinical data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/06/2015", "last_updated_date": "08/06/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-getting-ready-publication-clinical-data" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 2-4 June 2015", "press_release": "Yes", "related_medicine_referral": "Coxevac;Poulvac E. coli;UpCard;Zulvac 8 Ovis;Zulvac 8 Bovis;Ypozane;Suvaxyn PCV;Suprelorin;Stronghold;ProZinc;Nobilis Influenza H5N2;Zulvac 1 Bovis;Zulvac 1 Ovis;Equilis Te;Emdocam;Ecoporc Shiga;Activyl Tick Plus;BTVPUR;BTVPUR Alsap 8;BTVPUR AlSap 1;BTVPUR AlSap 2-4", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "05/06/2015", "last_updated_date": "05/06/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-2-4-june-2015" }, { "title": "Watch the live broadcast of EMA's workshop on bacteriophages on Monday 8 June from 09:00", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/06/2015", "last_updated_date": "05/06/2015", "news_url": "https://www.ema.europa.eu/en/news/watch-live-broadcast-emas-workshop-bacteriophages-monday-8-june-0900" }, { "title": "Regulatory information – User testing of electronic application forms underway", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/06/2015", "last_updated_date": "02/06/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-user-testing-electronic-application-forms-underway" }, { "title": "Regulatory information – Update of EMA recommendations for 2015/2016 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/05/2015", "last_updated_date": "27/05/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-update-ema-recommendations-2015-2016-seasonal-flu-vaccine-composition" }, { "title": "First-in-class treatment to lower cholesterol", "press_release": "Yes", "related_medicine_referral": "Repatha", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/05/2015", "last_updated_date": "22/05/2015", "news_url": "https://www.ema.europa.eu/en/news/first-class-treatment-lower-cholesterol" }, { "title": "New treatment option recommended for patients with advanced melanoma", "press_release": "Yes", "related_medicine_referral": "Keytruda", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/05/2015", "last_updated_date": "22/05/2015", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-option-recommended-patients-advanced-melanoma" }, { "title": "New treatment option for patients with advanced lung cancer", "press_release": "Yes", "related_medicine_referral": "Nivolumab BMS", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/05/2015", "last_updated_date": "22/05/2015", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-option-patients-advanced-lung-cancer" }, { "title": "EMA recommends treatment for rare cancer in children", "press_release": "Yes", "related_medicine_referral": "Unituxin", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "22/05/2015", "last_updated_date": "22/05/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-treatment-rare-cancer-children" }, { "title": "First medicine for rare blood cancer", "press_release": "Yes", "related_medicine_referral": "Imbruvica", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/05/2015", "last_updated_date": "22/05/2015", "news_url": "https://www.ema.europa.eu/en/news/first-medicine-rare-blood-cancer" }, { "title": "GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed studies", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/05/2015", "last_updated_date": "22/05/2015", "news_url": "https://www.ema.europa.eu/en/news/gvk-biosciences-european-medicines-agency-confirms-recommendation-suspend-medicines-over-flawed-studies" }, { "title": "Updated advice on use of high-dose ibuprofen", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/05/2015", "last_updated_date": "22/05/2015", "news_url": "https://www.ema.europa.eu/en/news/updated-advice-use-high-dose-ibuprofen" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015", "press_release": "No", "related_medicine_referral": "Fycompa;Imbruvica;Aripiprazole Mylan;Bortezomib Accord;Pregabalin Zentiva;Nivolumab BMS;Unituxin;Repatha;Omidria;Keytruda;Evotaz;Corluxin;Xultophy;Stelara;Simponi;Kuvan", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/05/2015", "last_updated_date": "22/05/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-may-2015" }, { "title": "European Medicines Agency closed 25 May 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "21/05/2015", "last_updated_date": "21/05/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-25-may-2015" }, { "title": "Exploring new ways to fight antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/05/2015", "last_updated_date": "21/05/2015", "news_url": "https://www.ema.europa.eu/en/news/exploring-new-ways-fight-antimicrobial-resistance" }, { "title": "Facilitating the development of gene therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "20/05/2015", "last_updated_date": "20/05/2015", "news_url": "https://www.ema.europa.eu/en/news/facilitating-development-gene-therapies" }, { "title": "European Medicines Agency closed 14-15 May 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "12/05/2015", "last_updated_date": "12/05/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-14-15-may-2015" }, { "title": "Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "12/05/2015", "last_updated_date": "12/05/2015", "news_url": "https://www.ema.europa.eu/en/news/safety-monitoring-medicines-ema-screen-medical-literature-400-active-substance-groups" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 5-7 May 2015", "press_release": "Yes", "related_medicine_referral": "Innovax-ILT;Canigen L4;Vectra 3D;TruScient;Trifexis;Slentrol;Poulvac E. coli;Melosus;Eryseng Parvo;Eryseng;Equilis Prequenza Te;Equilis Prequenza;Contacera;Circovac;Cerenia;Cardalis;BTVPUR;BTVPUR AlSap 1;Broadline;Rhiniseng;Lodipressin;Nobivac L4", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/05/2015", "last_updated_date": "08/05/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-may-2015" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2015", "press_release": "No", "related_medicine_referral": "Tysabri;Relvar Ellipta;Vylaer Spiromax;Budesonide/Formoterol Teva;BiResp Spiromax;DuoResp Spiromax;Revinty Ellipta;Tysabri", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "08/05/2015", "last_updated_date": "08/05/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-may-2015" }, { "title": "EMA tightens rules on “revolving door” for committee members and experts", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/05/2015", "last_updated_date": "01/01/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-tightens-rules-revolving-door-committee-members-experts-0" }, { "title": "EMA tightens rules on 'revolving door' for committee members and experts", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/05/2015", "last_updated_date": "06/05/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-tightens-rules-revolving-door-committee-members-experts" }, { "title": "Progress in science, medicines, health", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/04/2015", "last_updated_date": "30/04/2015", "news_url": "https://www.ema.europa.eu/en/news/progress-science-medicines-health" }, { "title": "European Medicines Agency closed 1 May 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/04/2015", "last_updated_date": "29/04/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-may-2015" }, { "title": "Regulatory information – reflection on chemical structure and properties to be considered for the evaluation of new active substance status", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/04/2015", "last_updated_date": "24/04/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-reflection-chemical-structure-properties-be-considered-evaluation-new-active-substance-status" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015", "press_release": "No", "related_medicine_referral": "Hetlioz;Levemir;Harvoni;Sovaldi;Daklinza;Corluxin;Duloxetine Sandoz;Vidaza;Tygacil;Resolor;Relistor;Invega;Esmya;Lympreva;Pregabalin Sandoz GmbH;Pregabalin Sandoz;Pregabalin Viatris (previously Pregabalin Mylan);Pregabalin Mylan Pharma;Duloxetine Viatris (previously Duloxetine Mylan);Aripiprazole Zentiva;Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen);Opdivo;Lumark;Lixiana", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "24/04/2015", "last_updated_date": "24/04/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-april-2015" }, { "title": "First EU treatment for rare sleep-wake disorder", "press_release": "Yes", "related_medicine_referral": "Hetlioz", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/04/2015", "last_updated_date": "24/04/2015", "news_url": "https://www.ema.europa.eu/en/news/first-eu-treatment-rare-sleep-wake-disorder" }, { "title": "New treatment for advanced melanoma", "press_release": "Yes", "related_medicine_referral": "Opdivo", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/04/2015", "last_updated_date": "24/04/2015", "news_url": "https://www.ema.europa.eu/en/news/new-treatment-advanced-melanoma" }, { "title": "EMA recommends avoidance of certain hepatitis C medicines and amiodarone together", "press_release": "Yes", "related_medicine_referral": "Harvoni;Daklinza;Sovaldi", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/04/2015", "last_updated_date": "24/04/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-avoidance-certain-hepatitis-c-medicines-amiodarone-together" }, { "title": "Codeine not to be used in children below 12 years for cough and cold", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "24/04/2015", "last_updated_date": "24/04/2015", "news_url": "https://www.ema.europa.eu/en/news/codeine-not-be-used-children-below-12-years-cough-cold" }, { "title": "Regulatory information – application deadline for participation in information-sharing pilot project for generics extended", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/04/2015", "last_updated_date": "21/04/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-application-deadline-participation-information-sharing-pilot-project-generics-extended" }, { "title": "Regulatory information – EMA provides advice notes on pharmacovigilance annual fees", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/04/2015", "last_updated_date": "20/04/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-provides-advice-notes-pharmacovigilance-annual-fees" }, { "title": "Scientific advice leads to stronger applications from industry", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Scientific advice", "news_summary": "", "first_published_date": "17/04/2015", "last_updated_date": "17/04/2015", "news_url": "https://www.ema.europa.eu/en/news/scientific-advice-leads-stronger-applications-industry" }, { "title": "Preventing medication errors in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/04/2015", "last_updated_date": "14/04/2015", "news_url": "https://www.ema.europa.eu/en/news/preventing-medication-errors-european-union" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 April 2015", "press_release": "Yes", "related_medicine_referral": "Sileo;Cerenia;Rabigen SAG2;Activyl;Zuprevo;Vectra Felis;Spironolactone Ceva;Posatex;Porcilis ColiClos;Panacur AquaSol;Palladia;Oncept IL-2;BTVPUR AlSap 2-4;Apoquel;Equilis Te;Coxevac;Bovilis BTV8;Poulvac E. coli;Equip WNV (previously Duvaxyn WNV);Suvaxyn PCV;Rhiniseng;Respiporc Flu3;Gripovac 3", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/04/2015", "last_updated_date": "13/04/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-april-2015" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/04/2015", "last_updated_date": "13/04/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-april-2015" }, { "title": "PRAC recommends updating advice on use of high-dose ibuprofen", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/04/2015", "last_updated_date": "13/04/2015", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-updating-advice-use-high-dose-ibuprofen" }, { "title": "Promoting high quality scientific research in paediatric medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/04/2015", "last_updated_date": "08/04/2015", "news_url": "https://www.ema.europa.eu/en/news/promoting-high-quality-scientific-research-paediatric-medicines" }, { "title": "World Health Day 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/04/2015", "last_updated_date": "07/04/2015", "news_url": "https://www.ema.europa.eu/en/news/world-health-day-2015" }, { "title": "Adjusted fees for applications to European Medicines Agency from 1 April 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "31/03/2015", "last_updated_date": "31/03/2015", "news_url": "https://www.ema.europa.eu/en/news/adjusted-fees-applications-european-medicines-agency-1-april-2015" }, { "title": "European Medicines Agency closed 2-6 April 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "31/03/2015", "last_updated_date": "31/03/2015", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-2-6-april-2015" }, { "title": "Making a difference to human and animal health", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/03/2015", "last_updated_date": "31/03/2015", "news_url": "https://www.ema.europa.eu/en/news/making-difference-human-animal-health" }, { "title": "Regulatory information - EU recommendations for 2015/2016 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-eu-recommendations-2015-2016-seasonal-flu-vaccine-composition" }, { "title": "Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)", "press_release": "Yes", "related_medicine_referral": "Gardasil", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "news_url": "https://www.ema.europa.eu/en/news/gardasil-9-offers-wider-protection-against-cancers-caused-human-papillomavirus-hpv" }, { "title": "Accelerated assessment fast-tracks Lenvima to benefit patients with thyroid cancer", "press_release": "Yes", "related_medicine_referral": "Lenvima", "categories": "Human", "topics": "Early access", "news_summary": "", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "news_url": "https://www.ema.europa.eu/en/news/accelerated-assessment-fast-tracks-lenvima-benefit-patients-thyroid-cancer" }, { "title": "Further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine", "press_release": "Yes", "related_medicine_referral": "Aclasta", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "news_url": "https://www.ema.europa.eu/en/news/further-measures-minimise-risk-osteonecrosis-jaw-bisphosphonate-medicine" }, { "title": "New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "news_url": "https://www.ema.europa.eu/en/news/new-restrictions-minimise-risks-effects-heart-rhythm-hydroxyzine-containing-medicines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2015", "press_release": "No", "related_medicine_referral": "Akynzeo;Gardasil 9;Tamiflu;Aclasta;Ketoconazole AID-SCFM;Voriconazole Hikma (previously Voriconazole Hospira);Synjardy;Lenvima", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-2015" }, { "title": "EMA Management Board: highlights of March 2015 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/03/2015", "last_updated_date": "20/03/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2015-meeting" }, { "title": "Celebrating 20 years: EMA launches anniversary book", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/03/2015", "last_updated_date": "18/03/2015", "news_url": "https://www.ema.europa.eu/en/news/celebrating-20-years-ema-launches-anniversary-book" }, { "title": "European Commissioner for Health and Food Safety visits EMA", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/03/2015", "last_updated_date": "17/03/2015", "news_url": "https://www.ema.europa.eu/en/news/european-commissioner-health-food-safety-visits-ema" }, { "title": "Science, Medicines, Health: Patients at the heart of future innovation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/03/2015", "last_updated_date": "16/03/2015", "news_url": "https://www.ema.europa.eu/en/news/science-medicines-health-patients-heart-future-innovation" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 March 2015", "press_release": "Yes", "related_medicine_referral": "Versican Plus DHPPi/L4;Versican Plus DHPPi/L4R;NexGard;Recuvyra;Procox;Cimalgex;Veraflox;Eurican Herpes 205;Nobilis IB 4-91;Draxxin;Rheumocam;Broadline;Versican Plus DHPPi", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/03/2015", "last_updated_date": "13/03/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-march-2015" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2015", "press_release": "No", "related_medicine_referral": "Aclasta", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/03/2015", "last_updated_date": "13/03/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-march-2015" }, { "title": "PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/03/2015", "last_updated_date": "13/03/2015", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-further-measures-minimise-risk-osteonecrosis-jaw-bisphosphonate-medicine" }, { "title": "PRAC recommends restrictions on the use of codeine for cough and cold in children", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Pharmacovigilance", "news_summary": "", "first_published_date": "13/03/2015", "last_updated_date": "13/03/2015", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-restrictions-use-codeine-cough-cold-children" }, { "title": "Pharmacovigilance fees – Information for companies on fees for safety monitoring of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "10/03/2015", "last_updated_date": "10/03/2015", "news_url": "https://www.ema.europa.eu/en/news/pharmacovigilance-fees-information-companies-fees-safety-monitoring-medicines" }, { "title": "Use of antimicrobials in animals - public consultations on two guidelines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "04/03/2015", "last_updated_date": "04/03/2015", "news_url": "https://www.ema.europa.eu/en/news/use-antimicrobials-animals-public-consultations-two-guidelines" }, { "title": "Jinarc recommended for approval in rare kidney disease", "press_release": "Yes", "related_medicine_referral": "Jinarc", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/02/2015", "last_updated_date": "27/02/2015", "news_url": "https://www.ema.europa.eu/en/news/jinarc-recommended-approval-rare-kidney-disease" }, { "title": "Zykadia recommended for approval in advanced non small cell lung cancer", "press_release": "Yes", "related_medicine_referral": "Zykadia", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/02/2015", "last_updated_date": "27/02/2015", "news_url": "https://www.ema.europa.eu/en/news/zykadia-recommended-approval-advanced-non-small-cell-lung-cancer" }, { "title": "Ambroxol and bromhexine expectorants: safety information to be updated", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/02/2015", "last_updated_date": "27/02/2015", "news_url": "https://www.ema.europa.eu/en/news/ambroxol-bromhexine-expectorants-safety-information-be-updated" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2015", "press_release": "No", "related_medicine_referral": "Jinarc;Rienso;Vectibix;Sustiva;Soliris;Toujeo (previously Optisulin);Humira;Avastin;Adenuric;Zykadia;Ristempa", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "27/02/2015", "last_updated_date": "27/02/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-february-2015" }, { "title": "Regulatory information - Adjusted fees for applications to European Medicines Agency from 1 April 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/02/2015", "last_updated_date": "26/02/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-european-medicines-agency-1-april-2015" }, { "title": "Rare Disease Day 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/02/2015", "last_updated_date": "26/02/2015", "news_url": "https://www.ema.europa.eu/en/news/rare-disease-day-2015" }, { "title": "Regulatory information - Transitioning to mandatory use of electronic application forms", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/02/2015", "last_updated_date": "25/02/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-transitioning-mandatory-use-electronic-application-forms" }, { "title": "Regulatory information - EMA introduces weekly start dates for the assessment of type II variations from March 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/02/2015", "last_updated_date": "20/02/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-introduces-weekly-start-dates-assessment-type-ii-variations-march-2015" }, { "title": "Regulatory information - Committee chairs' handwritten signatures no longer included in opinion documents from March 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/02/2015", "last_updated_date": "20/02/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-committee-chairs-handwritten-signatures-no-longer-included-opinion-documents-march-2015" }, { "title": "Identification of medicines: EU task force to implement new international standards", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/02/2015", "last_updated_date": "20/02/2015", "news_url": "https://www.ema.europa.eu/en/news/identification-medicines-eu-task-force-implement-new-international-standards" }, { "title": "Safety signals: recommendations now available in all EU languages", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "18/02/2015", "last_updated_date": "18/02/2015", "news_url": "https://www.ema.europa.eu/en/news/safety-signals-recommendations-now-available-all-eu-languages" }, { "title": "Major European research project on monitoring and evaluation of medicines concludes", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/02/2015", "last_updated_date": "16/02/2015", "news_url": "https://www.ema.europa.eu/en/news/major-european-research-project-monitoring-evaluation-medicines-concludes" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 February 2015", "press_release": "Yes", "related_medicine_referral": "Metacam;Suvaxyn PCV;Zulvac 1+8 Ovis;Zulvac 1+8 Bovis;Recocam;ProteqFlu-Te;ProteqFlu;Previcox;Meloxidolor;Econor;Comfortis;CaniLeish;Aivlosin;Novem;Zuprevo;NexGard", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/02/2015", "last_updated_date": "13/02/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-february-2015" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 February 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/02/2015", "last_updated_date": "13/02/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-february-2015" }, { "title": "PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/02/2015", "last_updated_date": "13/02/2015", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-new-measures-minimise-known-heart-risks-hydroxyzine-containing-medicines" }, { "title": "EMA explains its redaction rules", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/02/2015", "last_updated_date": "10/02/2015", "news_url": "https://www.ema.europa.eu/en/news/ema-explains-its-redaction-rules" }, { "title": "Regulatory information – Changes in SME registration procedures to reduce administrative burden", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "04/02/2015", "last_updated_date": "04/02/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-changes-sme-registration-procedures-reduce-administrative-burden" }, { "title": "Better use of EMA support tools and increased success rate for SME applications", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "04/02/2015", "last_updated_date": "04/02/2015", "news_url": "https://www.ema.europa.eu/en/news/better-use-ema-support-tools-increased-success-rate-sme-applications" }, { "title": "EU report provides basis for effective fight against development of resistant bacteria", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/01/2015", "last_updated_date": "30/01/2015", "news_url": "https://www.ema.europa.eu/en/news/eu-report-provides-basis-effective-fight-against-development-resistant-bacteria" }, { "title": "Increasing the availability of veterinary medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/01/2015", "last_updated_date": "27/01/2015", "news_url": "https://www.ema.europa.eu/en/news/increasing-availability-veterinary-medicines" }, { "title": "Central repository to facilitate assessment of medicines safety reports", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/01/2015", "last_updated_date": "26/01/2015", "news_url": "https://www.ema.europa.eu/en/news/central-repository-facilitate-assessment-medicines-safety-reports" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 2015", "press_release": "No", "related_medicine_referral": "Dutrebis;Kengrexal;Saxenda;Ikervis;Teysuno;Prevenar 13;Jakavi;Eylea;Aloxi;Abraxane;Sivextro;Raplixa;Tenkasi (previously Orbactiv)", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/01/2015", "last_updated_date": "23/01/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-january-2015" }, { "title": "GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/01/2015", "last_updated_date": "23/01/2015", "news_url": "https://www.ema.europa.eu/en/news/gvk-biosciences-european-medicines-agency-recommends-suspending-medicines-over-flawed-studies" }, { "title": "Saxenda recommended for approval in weight management in adults", "press_release": "Yes", "related_medicine_referral": "Saxenda", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/01/2015", "last_updated_date": "23/01/2015", "news_url": "https://www.ema.europa.eu/en/news/saxenda-recommended-approval-weight-management-adults" }, { "title": "Regulatory information - Paediatric guidance revised to reflect changes to European Commission guideline", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "21/01/2015", "last_updated_date": "21/01/2015", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-paediatric-guidance-revised-reflect-changes-european-commission-guideline" }, { "title": "New international standard to improve safety of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/01/2015", "last_updated_date": "21/01/2015", "news_url": "https://www.ema.europa.eu/en/news/new-international-standard-improve-safety-medicines" }, { "title": "Public consultation on application of transparency rules of EU Clinical Trial Regulation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/01/2015", "last_updated_date": "21/01/2015", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-application-transparency-rules-eu-clinical-trial-regulation" }, { "title": "Europe to boost international cooperation on generics", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/01/2015", "last_updated_date": "19/01/2015", "news_url": "https://www.ema.europa.eu/en/news/europe-boost-international-cooperation-generics" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 January 2015", "press_release": "Yes", "related_medicine_referral": "Lodipressin;Coliprotec F4;Zulvac 1 Ovis;Pexion;Zulvac 1 Bovis;RevitaCAM;Equisolon;Kexxtone;Bravecto;Bovilis BTV8;Purevax RCP FeLV;Purevax RCPCh FeLV;Purevax RC;Purevax RCP;Purevax RCPCh;Novem;Metacam;Eryseng Parvo;Bluevac BTV (previously Bluevac BTV8);Acticam;Stronghold", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/01/2015", "last_updated_date": "16/01/2015", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-january-2015" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/01/2015", "last_updated_date": "12/01/2015", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-january-2015" }, { "title": "PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/01/2015", "last_updated_date": "12/01/2015", "news_url": "https://www.ema.europa.eu/en/news/prac-considers-risk-severe-allergic-reactions-ambroxol-bromhexine-containing-medicines-be-small" }, { "title": "Record number of medicines for rare diseases recommended for approval in 2014", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/01/2015", "last_updated_date": "09/01/2015", "news_url": "https://www.ema.europa.eu/en/news/record-number-medicines-rare-diseases-recommended-approval-2014" }, { "title": "World Arthritis Day", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/01/2012", "last_updated_date": "01/01/2015", "news_url": "https://www.ema.europa.eu/en/news/world-arthritis-day" }, { "title": "International Clinical Trials' Day", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "news_url": "https://www.ema.europa.eu/en/news/international-clinical-trials-day" }, { "title": "Registration opens for FDA/EMA orphan product designation and grant workshop", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "02/09/2013", "last_updated_date": "01/01/2015", "news_url": "https://www.ema.europa.eu/en/news/registration-opens-fda-ema-orphan-product-designation-grant-workshop" }, { "title": "Status of the adaptive pathways pilot project", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/12/2014", "last_updated_date": "22/12/2014", "news_url": "https://www.ema.europa.eu/en/news/status-adaptive-pathways-pilot-project" }, { "title": "Regulatory information - Simplification of submission of product information updates in periodic safety update reports for nationally authorised products", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/12/2014", "last_updated_date": "22/12/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-simplification-submission-product-information-updates-periodic-safety-update-reports-nationally-authorised-products" }, { "title": "European Medicines Agency closed 24 December 2014 to 4 January 2015", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/12/2014", "last_updated_date": "22/12/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-24-december-2014-4-january-2015" }, { "title": "EMA Management Board: highlights of December 2014 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/12/2014", "last_updated_date": "19/12/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2014-meeting" }, { "title": "Mitigating risks due to the use of antibiotics in animals", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/12/2014", "last_updated_date": "19/12/2014", "news_url": "https://www.ema.europa.eu/en/news/mitigating-risks-due-use-antibiotics-animals" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 December 2014", "press_release": "No", "related_medicine_referral": "Clopidogrel ratiopharm;Holoclar;Revlimid;Xiapex;Velcade;Tresiba;Tasermity;Xydalba;Xadago;Quinsair;Mysimba", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "19/12/2014", "last_updated_date": "19/12/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-december-2014" }, { "title": "Mysimba recommended for approval in weight management in adults", "press_release": "Yes", "related_medicine_referral": "Mysimba", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/12/2014", "last_updated_date": "19/12/2014", "news_url": "https://www.ema.europa.eu/en/news/mysimba-recommended-approval-weight-management-adults" }, { "title": "First stem-cell therapy recommended for approval in EU", "press_release": "Yes", "related_medicine_referral": "Holoclar", "categories": "Human", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "19/12/2014", "last_updated_date": "19/12/2014", "news_url": "https://www.ema.europa.eu/en/news/first-stem-cell-therapy-recommended-approval-eu" }, { "title": "Focus on innovative medicines for animals", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Innovation", "news_summary": "", "first_published_date": "16/12/2014", "last_updated_date": "16/12/2014", "news_url": "https://www.ema.europa.eu/en/news/focus-innovative-medicines-animals" }, { "title": "Experimental Ebola treatments still at early stage of development", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/12/2014", "last_updated_date": "16/12/2014", "news_url": "https://www.ema.europa.eu/en/news/experimental-ebola-treatments-still-early-stage-development" }, { "title": "Adaptive pathways: a future approach to bring new medicines to patients?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Early access", "news_summary": "", "first_published_date": "15/12/2014", "last_updated_date": "15/12/2014", "news_url": "https://www.ema.europa.eu/en/news/adaptive-pathways-future-approach-bring-new-medicines-patients" }, { "title": "Diclofenac use in animals poses a risk to European vultures", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/12/2014", "last_updated_date": "12/12/2014", "news_url": "https://www.ema.europa.eu/en/news/diclofenac-use-animals-poses-risk-european-vultures" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 December 2014", "press_release": "Yes", "related_medicine_referral": "Suvaxyn CSF Marker;Zulvac SBV;Zulvac 8 Ovis;Zulvac 8 Bovis;Semintra;Rheumocam;Respiporc Flu3;Reconcile;Pirsue;Nobivac L4;Gripovac 3;Ecoporc Shiga;Cortavance;Broadline;Activyl Tick Plus;Purevax RCP FeLV;Purevax RCPCh FeLV;Purevax RC;Purevax RCP;Purevax RCPCh;Leucogen;Leucofeligen FeLV/RCP;Equip WNV (previously Duvaxyn WNV);Easotic", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/12/2014", "last_updated_date": "12/12/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-december-2014" }, { "title": "GVK Biosciences review: some Member States suspend marketing authorisations for concerned medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/12/2014", "last_updated_date": "05/12/2014", "news_url": "https://www.ema.europa.eu/en/news/gvk-biosciences-review-some-member-states-suspend-marketing-authorisations-concerned-medicines" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 December 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "05/12/2014", "last_updated_date": "05/12/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-4-december-2014" }, { "title": "No evidence that Fluad vaccine caused deaths in Italy", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/12/2014", "last_updated_date": "03/12/2014", "news_url": "https://www.ema.europa.eu/en/news/no-evidence-fluad-vaccine-caused-deaths-italy" }, { "title": "EMA Management Board discusses next steps after judgment of EU Civil Service Tribunal", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/12/2014", "last_updated_date": "01/12/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-discusses-next-steps-after-judgment-eu-civil-service-tribunal" }, { "title": "Investigation into reports of serious adverse events following use of Fluad", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/11/2014", "last_updated_date": "28/11/2014", "news_url": "https://www.ema.europa.eu/en/news/investigation-reports-serious-adverse-events-following-use-fluad" }, { "title": "New antiretrovirals improve quality of life of HIV/AIDS patients", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/11/2014", "last_updated_date": "28/11/2014", "news_url": "https://www.ema.europa.eu/en/news/new-antiretrovirals-improve-quality-life-hiv-aids-patients" }, { "title": "Regulatory information - EMA releases practical guidance on access-to-documents requests", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/11/2014", "last_updated_date": "24/11/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-releases-practical-guidance-access-documents-requests" }, { "title": "Regulatory update - EMA encourages companies to submit type-I variations for 2014 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/11/2014", "last_updated_date": "21/11/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2014-end-november" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 November 2014", "press_release": "No", "related_medicine_referral": "Cerdelga;Cosentyx;Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva);Corlentor;Procoralan;Ceprotin;Egranli;ellaOne;ellaOne;Travatan;Inductos;Zontivity;Viekirax;Rasagiline ratiopharm;Senshio;Otezla;Ofev;Exviera", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/11/2014", "last_updated_date": "21/11/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-november-2014" }, { "title": "Cerdelga recommended for approval in type 1 Gaucher disease", "press_release": "Yes", "related_medicine_referral": "Cerdelga", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/11/2014", "last_updated_date": "21/11/2014", "news_url": "https://www.ema.europa.eu/en/news/cerdelga-recommended-approval-type-1-gaucher-disease" }, { "title": "Two new medicines recommended for the treatment of chronic hepatitis C", "press_release": "Yes", "related_medicine_referral": "Exviera;Viekirax", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/11/2014", "last_updated_date": "21/11/2014", "news_url": "https://www.ema.europa.eu/en/news/two-new-medicines-recommended-treatment-chronic-hepatitis-c" }, { "title": "EMA recommends availability of ellaOne emergency contraceptive without prescription", "press_release": "Yes", "related_medicine_referral": "ellaOne", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/11/2014", "last_updated_date": "21/11/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-availability-ellaone-emergency-contraceptive-without-prescription" }, { "title": "European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)", "press_release": "Yes", "related_medicine_referral": "Procoralan;Corlentor", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/11/2014", "last_updated_date": "21/11/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-measures-reduce-risk-heart-problems-corlentor-procoralan-ivabradine" }, { "title": "CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/11/2014", "last_updated_date": "21/11/2014", "news_url": "https://www.ema.europa.eu/en/news/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-girls" }, { "title": "No consistent evidence of an increased risk of heart problems with testosterone medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/11/2014", "last_updated_date": "21/11/2014", "news_url": "https://www.ema.europa.eu/en/news/no-consistent-evidence-increased-risk-heart-problems-testosterone-medicines" }, { "title": "Conflicts of interests: revised EMA policy reflects more balanced approach", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/11/2014", "last_updated_date": "20/11/2014", "news_url": "https://www.ema.europa.eu/en/news/conflicts-interests-revised-ema-policy-reflects-more-balanced-approach" }, { "title": "European Medicines Agency welcomes new Head of Administration", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "17/11/2014", "last_updated_date": "17/11/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-administration" }, { "title": "European Antibiotic Awareness Day 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/11/2014", "last_updated_date": "14/11/2014", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-2014" }, { "title": "Judgement by European Union Civil Service Tribunal on appointment procedure of EMA Executive Director", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/11/2014", "last_updated_date": "13/11/2014", "news_url": "https://www.ema.europa.eu/en/news/judgement-european-union-civil-service-tribunal-appointment-procedure-ema-executive-director" }, { "title": "Herbal medicines 2004 – 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "13/11/2014", "last_updated_date": "13/11/2014", "news_url": "https://www.ema.europa.eu/en/news/herbal-medicines-2004-2014" }, { "title": "EMA responds to European Ombudsman", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/11/2014", "last_updated_date": "12/11/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-responds-european-ombudsman" }, { "title": "Regulatory information – New tool for companies to facilitate maintenance of information on authorised medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/11/2014", "last_updated_date": "10/11/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-new-tool-companies-facilitate-maintenance-information-authorised-medicines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 November 2014", "press_release": "Yes", "related_medicine_referral": "Nexgard Spectra;Zulvac 1 Bovis;TruScient;Trifexis;ProZinc;Prac-tic;Poulvac E. coli;Porcilis ColiClos;Panacur AquaSol;Meloxidyl;Leucofeligen FeLV/RCP;Inflacam;Hiprabovis IBR Marker Live;Equilis Prequenza Te;Equilis Prequenza;Contacera;Cerenia;Cardalis;BTVPUR;BTVPUR AlSap 1;Acticam;Coxevac;Bluevac BTV (previously Bluevac BTV8);Purevax RCP FeLV;Purevax FeLV;Purevax RCPCh FeLV;Zulvac 1+8 Ovis;Zulvac 8 Ovis;Zulvac 1 Ovis;Zulvac 1+8 Bovis;Zulvac 8 Bovis", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "07/11/2014", "last_updated_date": "07/11/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-4-6-november-2014" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 November 2014", "press_release": "No", "related_medicine_referral": "Procoralan;Corlentor;Tecfidera", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/11/2014", "last_updated_date": "07/11/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-november-2014" }, { "title": "PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)", "press_release": "Yes", "related_medicine_referral": "Procoralan;Corlentor", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/11/2014", "last_updated_date": "07/11/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-measures-reduce-risk-heart-problems-corlentor-procoralan-ivabradine" }, { "title": "Revised framework for development of influenza vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/10/2014", "last_updated_date": "30/10/2014", "news_url": "https://www.ema.europa.eu/en/news/revised-framework-development-influenza-vaccines" }, { "title": "Facilitating global development of biosimilars", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Biosimilars", "news_summary": "", "first_published_date": "29/10/2014", "last_updated_date": "29/10/2014", "news_url": "https://www.ema.europa.eu/en/news/facilitating-global-development-biosimilars" }, { "title": "European Medicines Agency closed 31 October 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/10/2014", "last_updated_date": "29/10/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-31-october-2014" }, { "title": "EMA advises on development plan for GSK Ebola vaccine", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "29/10/2014", "last_updated_date": "29/10/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-advises-development-plan-gsk-ebola-vaccine" }, { "title": "Regulatory update - Changes to scientific advice procedures as of 17 November 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/10/2014", "last_updated_date": "24/10/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-changes-scientific-advice-procedures-17-november-2014" }, { "title": "Regulatory update - EMA encourages companies to submit quality type I variations for 2014 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/10/2014", "last_updated_date": "24/10/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-quality-type-i-variations-2014-end-november" }, { "title": "Regulatory update – All referral procedures to be sent via eSubmission Gateway / Web Client from 1 November 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/10/2014", "last_updated_date": "24/10/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-update-all-referral-procedures-be-sent-esubmission-gateway-web-client-1-november-2014" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 October 2014", "press_release": "No", "related_medicine_referral": "Duavive;Duloxetine Lilly;Xtandi;Scenesse;Rixubis;Trevicta (previously Paliperidone Janssen);Lynparza", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "24/10/2014", "last_updated_date": "24/10/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-october-2014" }, { "title": "Scenesse recommended for rare disease that causes intolerance to sunlight", "press_release": "Yes", "related_medicine_referral": "Scenesse", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/10/2014", "last_updated_date": "24/10/2014", "news_url": "https://www.ema.europa.eu/en/news/scenesse-recommended-rare-disease-causes-intolerance-sunlight" }, { "title": "Lynparza recommended for approval in ovarian cancer", "press_release": "Yes", "related_medicine_referral": "Lynparza", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/10/2014", "last_updated_date": "24/10/2014", "news_url": "https://www.ema.europa.eu/en/news/lynparza-recommended-approval-ovarian-cancer" }, { "title": "European Medicines Agency completes review of polymyxin-based medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/10/2014", "last_updated_date": "24/10/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-completes-review-polymyxin-based-medicines" }, { "title": "European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig", "press_release": "Yes", "related_medicine_referral": "Iclusig", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/10/2014", "last_updated_date": "24/10/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-further-measures-minimise-risk-blood-vessel-blockage-iclusig" }, { "title": "EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/10/2014", "last_updated_date": "22/10/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-ready-start-assessment-ebola-vaccines-treatments-soon-data-are-made-available" }, { "title": "Speeding up development of Ebola treatments and vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/10/2014", "last_updated_date": "20/10/2014", "news_url": "https://www.ema.europa.eu/en/news/speeding-development-ebola-treatments-vaccines" }, { "title": "15% decrease in sales of veterinary antibiotics in Europe", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/10/2014", "last_updated_date": "15/10/2014", "news_url": "https://www.ema.europa.eu/en/news/15-decrease-sales-veterinary-antibiotics-europe" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 October 2014", "press_release": "Yes", "related_medicine_referral": "Bovela;Zactran;Recuvyra;Pexion;Nobivac Myxo-RHD;Vectra 3D;ProMeris Duo;ProMeris;Oncept IL-2;MS-H Vaccine;Leucogen;Previcox;Equioxx;Certifect;BTVPUR AlSap 2-4;Apoquel;Aivlosin;Respiporc Flu3;Gripovac 3", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/10/2014", "last_updated_date": "10/10/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-october-2014" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 October 2014", "press_release": "No", "related_medicine_referral": "Iclusig", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/10/2014", "last_updated_date": "10/10/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-october-2014" }, { "title": "PRAC recommends strengthening the restrictions on the use of valproate in women and girls", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/10/2014", "last_updated_date": "10/10/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-strengthening-restrictions-use-valproate-women-girls" }, { "title": "PRAC review does not confirm increase in heart problems with testosterone medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/10/2014", "last_updated_date": "10/10/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-review-does-not-confirm-increase-heart-problems-testosterone-medicines" }, { "title": "PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig", "press_release": "Yes", "related_medicine_referral": "Iclusig", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/10/2014", "last_updated_date": "10/10/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-further-measures-minimise-risk-blood-vessel-blockage-iclusig" }, { "title": "Information on suspected side effects of nationally authorised medicines now available through a single website", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/10/2014", "last_updated_date": "06/10/2014", "news_url": "https://www.ema.europa.eu/en/news/information-suspected-side-effects-nationally-authorised-medicines-now-available-through-single-website" }, { "title": "EMA Management Board: highlights of October 2014 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/10/2014", "last_updated_date": "06/10/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2014-meeting" }, { "title": "Publication of clinical reports", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/10/2014", "last_updated_date": "02/10/2014", "news_url": "https://www.ema.europa.eu/en/news/publication-clinical-reports" }, { "title": "Facilitating applications for paediatric investigation plans", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/09/2014", "last_updated_date": "30/09/2014", "news_url": "https://www.ema.europa.eu/en/news/facilitating-applications-paediatric-investigation-plans" }, { "title": "Small and medium-sized enterprises: driving innovation in medicines", "press_release": "No", "related_medicine_referral": "Translarna;Jetrea", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "29/09/2014", "last_updated_date": "29/09/2014", "news_url": "https://www.ema.europa.eu/en/news/small-medium-sized-enterprises-driving-innovation-medicines" }, { "title": "Ketoconazole HRA recommended for approval in Cushing's syndrome", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/09/2014", "last_updated_date": "26/09/2014", "news_url": "https://www.ema.europa.eu/en/news/ketoconazole-hra-recommended-approval-cushings-syndrome" }, { "title": "Ebola outbreak: EMA to review experimental medicines to support treatment decisions", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/09/2014", "last_updated_date": "26/09/2014", "news_url": "https://www.ema.europa.eu/en/news/ebola-outbreak-ema-review-experimental-medicines-support-treatment-decisions" }, { "title": "EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)", "press_release": "Yes", "related_medicine_referral": "Thymanax;Valdoxan", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/09/2014", "last_updated_date": "26/09/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-positive-benefit-risk-antidepressant-valdoxan-thymanax-agomelatine" }, { "title": "Harvoni recommended for the treatment of chronic hepatitis C", "press_release": "Yes", "related_medicine_referral": "Harvoni", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/09/2014", "last_updated_date": "26/09/2014", "news_url": "https://www.ema.europa.eu/en/news/harvoni-recommended-treatment-chronic-hepatitis-c" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014", "press_release": "No", "related_medicine_referral": "Cyramza;Brimica Genuair;Signifor;Maci;Valdoxan;Thymanax;Javlor;Avastin;Prezista;Vargatef;Trulicity;Tadalafil Mylan;Rezolsta;Moventig;Lymphoseek;Ketoconazole Esteve (previously Ketoconazole HRA);Harvoni;Egranli;Budesonide/Formoterol Teva Pharma B.V.;Vylaer Spiromax;Budesonide/Formoterol Teva;Duaklir Genuair", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/09/2014", "last_updated_date": "26/09/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-september-2014" }, { "title": "Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "26/09/2014", "last_updated_date": "26/09/2014", "news_url": "https://www.ema.europa.eu/en/news/patients-discuss-benefit-risk-evaluation-medicines-committee-medicinal-products-human-use" }, { "title": "Avoiding duplication of clinical trials in children", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "23/09/2014", "last_updated_date": "23/09/2014", "news_url": "https://www.ema.europa.eu/en/news/avoiding-duplication-clinical-trials-children" }, { "title": "Policy on veterinary medicines for minor use, minor species / limited market revised", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/09/2014", "last_updated_date": "16/09/2014", "news_url": "https://www.ema.europa.eu/en/news/policy-veterinary-medicines-minor-use-minor-species-limited-market-revised" }, { "title": "Is diclofenac a threat to European vultures?", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/09/2014", "last_updated_date": "12/09/2014", "news_url": "https://www.ema.europa.eu/en/news/diclofenac-threat-european-vultures" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 September 2014", "press_release": "Yes", "related_medicine_referral": "Porcilis PCV M Hyo;Activyl Tick Plus;Porcilis AR-T DF;Flexicam;Suvaxyn PCV;Meloxoral;Zulvac 8 Ovis;Zulvac 8 Bovis;Zolvix;Startvac;Vaxxitek HVT+IBD;Purevax RCPCh FeLV;Purevax RCPCh;Purevax RCCh;Bovalto Ibraxion;Eurican Herpes 205;Circovac;Fevaxyn Pentofel;Hiprabovis IBR Marker Live;Equilis Prequenza;Equilis Prequenza Te;Equilis StrepE", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/09/2014", "last_updated_date": "12/09/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-september-2014" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 September 2014", "press_release": "No", "related_medicine_referral": "Valdoxan;Thymanax", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/09/2014", "last_updated_date": "12/09/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-september-2014" }, { "title": "Regulatory information - Further guidance on adaptive licensing pilot project available", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/09/2014", "last_updated_date": "11/09/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-further-guidance-adaptive-licensing-pilot-project-available" }, { "title": "New legislation for veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/09/2014", "last_updated_date": "10/09/2014", "news_url": "https://www.ema.europa.eu/en/news/new-legislation-veterinary-medicines" }, { "title": "European Medicines Agency website unavailable Saturday 6 September 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "05/09/2014", "last_updated_date": "05/09/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-saturday-6-september-2014" }, { "title": "Medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Innovation;Medicines", "news_summary": "", "first_published_date": "04/09/2014", "last_updated_date": "04/09/2014", "news_url": "https://www.ema.europa.eu/en/news/medicines-regulators-work-together-internationally-find-innovative-solutions-facilitate-evaluation-access-potential-new-medicines-counter-ebola-outbreaks" }, { "title": "European Medicines Agency welcomes new Head of Communication Department and new Head of Human Resources", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/09/2014", "last_updated_date": "01/09/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-communication-department-new-head-human-resources" }, { "title": "Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/09/2014", "last_updated_date": "01/09/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-european-medicines-agency-updates-guidance-european-union-periodic-safety-update-report-single-assessment-nationally-authorised-medicines" }, { "title": "European Medicines Agency publishes booklet on European regulatory system for medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/08/2014", "last_updated_date": "26/08/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-booklet-european-regulatory-system-medicines" }, { "title": "European Medicines Agency closed 25 August 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "21/08/2014", "last_updated_date": "21/08/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-25-august-2014" }, { "title": "CMDh endorses restricted use of bromocriptine for stopping breast milk production", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/08/2014", "last_updated_date": "21/08/2014", "news_url": "https://www.ema.europa.eu/en/news/cmdh-endorses-restricted-use-bromocriptine-stopping-breast-milk-production" }, { "title": "Europe to boost cooperation with international partners on generics", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/08/2014", "last_updated_date": "07/08/2014", "news_url": "https://www.ema.europa.eu/en/news/europe-boost-cooperation-international-partners-generics" }, { "title": "European Medicines Agency consults on updates to its policy on access to EudraVigilance", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "04/08/2014", "last_updated_date": "04/08/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-consults-updates-its-policy-access-eudravigilance" }, { "title": "European Medicines Agency looks to stimulate better use of genomic data and biomarkers in medicines development and safety monitoring", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "04/08/2014", "last_updated_date": "04/08/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-looks-stimulate-better-use-genomic-data-biomarkers-medicines-development-safety-monitoring" }, { "title": "Antimicrobial resistance – European Medicines Agency releases draft advice on the impact on public health and animal health of the use of antibiotics in animals", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Antimicrobial resistance;Medicines", "news_summary": "", "first_published_date": "01/08/2014", "last_updated_date": "01/08/2014", "news_url": "https://www.ema.europa.eu/en/news/antimicrobial-resistance-european-medicines-agency-releases-draft-advice-impact-public-health-animal-health-use-antibiotics-animals" }, { "title": "European Medicines Agency publishes first public summaries of Paediatric Committee evaluations of paediatric investigation plans", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "31/07/2014", "last_updated_date": "31/07/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-first-public-summaries-paediatric-committee-evaluations-paediatric-investigation-plans" }, { "title": "European Medicines Agency invites comments on new overarching guidance for the development of influenza vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "31/07/2014", "last_updated_date": "31/07/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-invites-comments-new-overarching-guidance-development-influenza-vaccines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014", "press_release": "No", "related_medicine_referral": "Baraclude;Busilvex;Neofordex;Zydelig;Xultophy;Imbruvica;Busulfan Fresenius Kabi;Accofil;Xgeva;RoActemra;Ozurdex;Humira;Ecalta", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/07/2014", "last_updated_date": "25/07/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-july-2014" }, { "title": "European Medicines Agency recommends approval of two new treatment options for rare cancers", "press_release": "Yes", "related_medicine_referral": "Imbruvica;Zydelig", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/07/2014", "last_updated_date": "25/07/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-two-new-treatment-options-rare-cancers" }, { "title": "World Hepatitis Day – European Medicines Agency uses regulatory tools to facilitate patient access to innovative medicines", "press_release": "No", "related_medicine_referral": "Sovaldi;Olysio;Daklinza", "categories": "Corporate", "topics": "Innovation;Medicines", "news_summary": "", "first_published_date": "25/07/2014", "last_updated_date": "25/07/2014", "news_url": "https://www.ema.europa.eu/en/news/world-hepatitis-day-european-medicines-agency-uses-regulatory-tools-facilitate-patient-access-innovative-medicines" }, { "title": "European Medicines Agency launches public consultation on rules of procedures for public hearings", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "24/07/2014", "last_updated_date": "24/07/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-public-consultation-rules-procedures-public-hearings" }, { "title": "Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight", "press_release": "Yes", "related_medicine_referral": "ellaOne", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2014", "last_updated_date": "24/07/2014", "news_url": "https://www.ema.europa.eu/en/news/levonorgestrel-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight" }, { "title": "CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2014", "last_updated_date": "24/07/2014", "news_url": "https://www.ema.europa.eu/en/news/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone" }, { "title": "Regulatory information – new formatted table template to be used in selected veterinary procedural submission cover letters", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "23/07/2014", "last_updated_date": "23/07/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-new-formatted-table-template-be-used-selected-veterinary-procedural-submission-cover-letters" }, { "title": "European Medicines Agency recommends 14 medicines for use in animals in first half of 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "16/07/2014", "last_updated_date": "16/07/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-14-medicines-use-animals-first-half-2014" }, { "title": "Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/07/2014", "last_updated_date": "14/07/2014", "news_url": "https://www.ema.europa.eu/en/news/guide-methodological-standards-pharmacoepidemiology-revised-include-pharmacogenetic-studies" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 July 2014", "press_release": "Yes", "related_medicine_referral": "Nobilis IB Primo QX;Coxevac;Zulvac 1 Ovis;Zulvac 1 Bovis;Semintra;Rhiniseng;RevitaCAM;Purevax Rabies;Proteq West Nile;Nobivac L4;Melosus;Equilis StrepE;Equilis Prequenza;Equilis Prequenza Te;Emdocam;Draxxin;Bovilis BTV8;Activyl;Aivlosin", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/07/2014", "last_updated_date": "11/07/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-july-2014" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 July 2014", "press_release": "No", "related_medicine_referral": "Rienso", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "11/07/2014", "last_updated_date": "11/07/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-july-2014" }, { "title": "European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014", "press_release": "No", "related_medicine_referral": "Mekinist;Gazyvaro;Neocepri;Folcepri;Vynfinit;Sylvant;Translarna;Daklinza;Entyvio", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "10/07/2014", "last_updated_date": "10/07/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-39-medicines-human-use-marketing-authorisation-first-half-2014" }, { "title": "Registration opens for workshop on clinical trial design in neuromyelitis optica to facilitate global medicine development in a rare and serious disease", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/07/2014", "last_updated_date": "10/07/2014", "news_url": "https://www.ema.europa.eu/en/news/registration-opens-workshop-clinical-trial-design-neuromyelitis-optica-facilitate-global-medicine-development-rare-serious-disease" }, { "title": "Management Board delays formal adoption of European Medicines Agency publication of clinical-trial-data policy to October 2014", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/07/2014", "last_updated_date": "09/07/2014", "news_url": "https://www.ema.europa.eu/en/news/management-board-delays-formal-adoption-european-medicines-agency-publication-clinical-trial-data-policy-october-2014" }, { "title": "European Medicines Agency releases revised guidance on advanced-therapy classification for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Medicines;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "30/06/2014", "last_updated_date": "30/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-revised-guidance-advanced-therapy-classification-public-consultation" }, { "title": "European Medicines Agency recommends approval of Daklinza in chronic hepatitis C", "press_release": "Yes", "related_medicine_referral": "Daklinza;Sovaldi", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "27/06/2014", "last_updated_date": "27/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-daklinza-chronic-hepatitis-c" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014", "press_release": "No", "related_medicine_referral": "Abasaglar (previously Abasria);Clopidogrel/Acetylsalicylic acid Teva;Vantobra;Triumeq;Tasigna;Faldaprevir Boehringer Ingelheim;Stivarga;Kalydeco;Isentress;Eylea;Enbrel;Eliquis;Avastin;Velphoro;Vizamyl;Daklinza", "categories": "Human;Corporate", "topics": "", "news_summary": "", "first_published_date": "27/06/2014", "last_updated_date": "27/06/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-june-2014" }, { "title": "European Medicines Agency welcomes publication of pharmacovigilance fee Regulation in Official Journal of the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "27/06/2014", "last_updated_date": "27/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-publication-pharmacovigilance-fee-regulation-official-journal-eu" }, { "title": "Outcome report on first European collaboration between regulators and HTA organisations: improving the contribution of regulatory assessment reports to health technology assessment", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/06/2014", "last_updated_date": "25/06/2014", "news_url": "https://www.ema.europa.eu/en/news/outcome-report-first-european-collaboration-between-regulators-hta-organisations-improving-contribution-regulatory-assessment-reports-health-technology-assessment" }, { "title": "European Commission launches logo for online pharmacies to protect patients from falsified medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/06/2014", "last_updated_date": "24/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-commission-launches-logo-online-pharmacies-protect-patients-falsified-medicines" }, { "title": "Registration opens for workshop on dose finding at the European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "23/06/2014", "last_updated_date": "23/06/2014", "news_url": "https://www.ema.europa.eu/en/news/registration-opens-workshop-dose-finding-european-medicines-agency" }, { "title": "Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/06/2014", "last_updated_date": "19/06/2014", "news_url": "https://www.ema.europa.eu/en/news/posting-clinical-trial-summary-results-european-clinical-trials-database-eudract-become-mandatory-sponsors-21-july-2014" }, { "title": "Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/06/2014", "last_updated_date": "16/06/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-companies-now-required-update-complete-improve-quality-information-authorised-medicines-submitted-european-medicines-agency" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "13/06/2014", "last_updated_date": "13/06/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-june-2014" }, { "title": "European Medicines Agency starts review of ibuprofen medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "13/06/2014", "last_updated_date": "13/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-review-ibuprofen-medicines" }, { "title": "European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "12/06/2014", "last_updated_date": "12/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-agrees-policy-publication-clinical-trial-data-more-user-friendly-amendments" }, { "title": "European Medicines Agency Management Board re-elects Sir Kent Woods as chair", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "12/06/2014", "last_updated_date": "12/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-management-board-re-elects-sir-kent-woods-chair" }, { "title": "European Medicines Agency responds to concerns on its publication of clinical trial data policy", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "11/06/2014", "last_updated_date": "11/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-responds-concerns-its-publication-clinical-trial-data-policy" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 June 2014", "press_release": "Yes", "related_medicine_referral": "Osurnia;Versican Plus L4;Zulvac 8 Ovis;Zulvac 8 Bovis;Trifexis;Suprelorin;Rheumocam;ProZinc;Onsior;Nobilis Influenza H5N2;Melovem;Kexxtone;Gonazon;Equilis Te;Ecoporc Shiga;Palladia;ProteqFlu-Te;ProteqFlu;Versican Plus Pi/L4R;Versican Plus Pi/L4", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "06/06/2014", "last_updated_date": "06/06/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-3-5-june-2014" }, { "title": "European Medicines Agency selects first two medicines to be included in its adaptive licensing pilot project", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "06/06/2014", "last_updated_date": "06/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-selects-first-two-medicines-be-included-its-adaptive-licensing-pilot-project" }, { "title": "Public consultation opens on European Medicines Agency's draft guide on monitoring of medical literature", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "05/06/2014", "last_updated_date": "05/06/2014", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-opens-european-medicines-agencys-draft-guide-monitoring-medical-literature" }, { "title": "Ranbaxy, Toansa assessment concluded: no risk to public health", "press_release": "Yes", "related_medicine_referral": "Enyglid;Nevirapine Teva;Repaglinide Teva;Repaglinide Krka", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/06/2014", "last_updated_date": "05/06/2014", "news_url": "https://www.ema.europa.eu/en/news/ranbaxy-toansa-assessment-concluded-no-risk-public-health" }, { "title": "European Medicines Agency closed 9 June 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "05/06/2014", "last_updated_date": "05/06/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-9-june-2014" }, { "title": "Update on investigation by Italian authorities into the supply of stolen medicines", "press_release": "No", "related_medicine_referral": "Herceptin;Alimta;MabThera;Avastin;Remicade", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/06/2014", "last_updated_date": "03/06/2014", "news_url": "https://www.ema.europa.eu/en/news/update-investigation-italian-authorities-supply-stolen-medicines" }, { "title": "Regulatory information – revised guideline on acceptability of names for human medicines is published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "03/06/2014", "last_updated_date": "03/06/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-revised-guideline-acceptability-names-human-medicines-published" }, { "title": "European Medicines Agency welcomes publication of the Clinical Trials Regulation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "28/05/2014", "last_updated_date": "28/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-publication-clinical-trials-regulation" }, { "title": "European Medicines Agency closed 29-30 May 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "27/05/2014", "last_updated_date": "27/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-29-30-may-2014" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2014", "press_release": "No", "related_medicine_referral": "Arzerra;Halaven;Translarna;Masiviera;Avastin;Gazyvaro;Simbrinza;Plegridy;Nuwiq;Envarsus;Osseor;Protelos;Reasanz;Nerventra", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "23/05/2014", "last_updated_date": "23/05/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-may-2014" }, { "title": "European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia", "press_release": "Yes", "related_medicine_referral": "Gazyvaro", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/05/2014", "last_updated_date": "23/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-gazyvaro-chronic-lymphocytic-leukaemia" }, { "title": "European Medicines Agency recommends first-in-class medicine for treatment of Duchenne muscular dystrophy", "press_release": "Yes", "related_medicine_referral": "Translarna", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/05/2014", "last_updated_date": "23/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-first-class-medicine-treatment-duchenne-muscular-dystrophy" }, { "title": "Combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted – CHMP endorses PRAC recommendation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "23/05/2014", "last_updated_date": "23/05/2014", "news_url": "https://www.ema.europa.eu/en/news/combined-use-medicines-affecting-renin-angiotensin-system-ras-be-restricted-chmp-endorses-prac-recommendation" }, { "title": "European Medicines Agency response to European Ombudsman letter regarding proactive publication of and access to clinical trial data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/05/2014", "last_updated_date": "22/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-response-european-ombudsman-letter-regarding-proactive-publication-access-clinical-trial-data" }, { "title": "European Medicines Agency and German Society for Transfusion Medicine and Immunohaematology to co-organise workshop on advanced therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/05/2014", "last_updated_date": "19/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-german-society-transfusion-medicine-immunohaematology-co-organise-workshop-advanced-therapies" }, { "title": "Registration opens for workshop of the European Network of Paediatric Research at the European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "15/05/2014", "last_updated_date": "15/05/2014", "news_url": "https://www.ema.europa.eu/en/news/registration-opens-workshop-european-network-paediatric-research-european-medicines-agency" }, { "title": "European Medicines Agency and European Chemicals Agency enhance cooperation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "14/05/2014", "last_updated_date": "14/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-chemicals-agency-enhance-cooperation" }, { "title": "European Medicines Agency and US Food and Drug Administration release joint proposal to facilitate clinical investigation of new medicines for Gaucher disease in children", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "14/05/2014", "last_updated_date": "14/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-release-joint-proposal-facilitate-clinical-investigation-new-medicines-gaucher-disease-children" }, { "title": "Transatlantic Taskforce on Antimicrobial Resistance reports progress and outcomes of 17 recommendations", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/05/2014", "last_updated_date": "13/05/2014", "news_url": "https://www.ema.europa.eu/en/news/transatlantic-taskforce-antimicrobial-resistance-reports-progress-outcomes-17-recommendations" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 May 2014", "press_release": "Yes", "related_medicine_referral": "Versican Plus Pi;Versican Plus DHPPi;Contacera;Vectra 3D;Cardalis;Inflacam;BTVPUR AlSap 1;BTVPUR;Panacur AquaSol;Poulvac E. coli;Masivet;Circovac;Cerenia;Convenia;Draxxin;Ibaflin;Suvaxyn Aujeszky 783 + O/W;Metacam;Eryseng;Eryseng Parvo", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/05/2014", "last_updated_date": "12/05/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-may-2014" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2014", "press_release": "No", "related_medicine_referral": "Rienso", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "08/05/2014", "last_updated_date": "08/05/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-may-2014" }, { "title": "Review of Corlentor/Procoralan started", "press_release": "Yes", "related_medicine_referral": "Procoralan;Corlentor", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "08/05/2014", "last_updated_date": "08/05/2014", "news_url": "https://www.ema.europa.eu/en/news/review-corlentor-procoralan-started" }, { "title": "Review of hydroxyzine-containing medicines started", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "08/05/2014", "last_updated_date": "08/05/2014", "news_url": "https://www.ema.europa.eu/en/news/review-hydroxyzine-containing-medicines-started" }, { "title": "European Medicines Agency releases best practice guidance on parallel scientific advice with health-technology-assessment bodies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "08/05/2014", "last_updated_date": "08/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-best-practice-guidance-parallel-scientific-advice-health-technology-assessment-bodies" }, { "title": "European Medicines Agency closed 9 May 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/05/2014", "last_updated_date": "07/05/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-9-may-2014" }, { "title": "Monitoring the safety of medicines: European Medicines Agency presents first report on implementation of pharmacovigilance legislation to the European Commission", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "02/05/2014", "last_updated_date": "02/05/2014", "news_url": "https://www.ema.europa.eu/en/news/monitoring-safety-medicines-european-medicines-agency-presents-first-report-implementation-pharmacovigilance-legislation-european-commission" }, { "title": "EMA publishes 2013 annual report", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/04/2014", "last_updated_date": "30/04/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-publishes-2013-annual-report" }, { "title": "European Medicines Agency closed 1 May 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/04/2014", "last_updated_date": "29/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-may-2014" }, { "title": "2013 annual report on EudraVigilance: over 1 million adverse reaction reports received and processed", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/04/2014", "last_updated_date": "28/04/2014", "news_url": "https://www.ema.europa.eu/en/news/2013-annual-report-eudravigilance-over-1-million-adverse-reaction-reports-received-processed" }, { "title": "European Medicines Agency recommends approval of Mekinist for the treatment of melanoma", "press_release": "Yes", "related_medicine_referral": "Mekinist", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/04/2014", "last_updated_date": "25/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-mekinist-treatment-melanoma" }, { "title": "European Medicines Agency recommends extending use of Nexavar to include treatment of differentiated thyroid cancer", "press_release": "Yes", "related_medicine_referral": "Nexavar", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/04/2014", "last_updated_date": "25/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-extending-use-nexavar-include-treatment-differentiated-thyroid-cancer" }, { "title": "European Medicines Agency recommendation on the use of Linoladiol N and Linoladiol HN estradiol-containing creams", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/04/2014", "last_updated_date": "25/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommendation-use-linoladiol-n-linoladiol-hn-estradiol-containing-creams" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2014", "press_release": "No", "related_medicine_referral": "Gilenya;Invega;Votrient;Issarlos;Ditelos;Mekinist;Silgard;Gardasil;Prolia;Pradaxa;Nexavar", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/04/2014", "last_updated_date": "25/04/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2014" }, { "title": "European Medicines Agency recommends revoking authorisations of Caustinerf arsenical and Yranicid arsenical used in dental procedures", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/04/2014", "last_updated_date": "25/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-revoking-authorisations-caustinerf-arsenical-yranicid-arsenical-used-dental-procedures" }, { "title": "CMDh confirms recommendations on restricting use of domperidone-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/04/2014", "last_updated_date": "25/04/2014", "news_url": "https://www.ema.europa.eu/en/news/cmdh-confirms-recommendations-restricting-use-domperidone-containing-medicines" }, { "title": "CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/04/2014", "last_updated_date": "25/04/2014", "news_url": "https://www.ema.europa.eu/en/news/cmdh-endorses-new-advice-minimise-risk-next-morning-impaired-driving-ability-mental-alertness-zolpidem" }, { "title": "World Veterinary Day 2014 – focus on animal welfare", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "25/04/2014", "last_updated_date": "25/04/2014", "news_url": "https://www.ema.europa.eu/en/news/world-veterinary-day-2014-focus-animal-welfare" }, { "title": "European Commission/European Medicines Agency - US Food and Drug Administration bilateral: update", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/04/2014", "last_updated_date": "22/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-commission-european-medicines-agency-us-food-drug-administration-bilateral-update" }, { "title": "European Medicines Agency update on stolen vials of Herceptin", "press_release": "Yes", "related_medicine_referral": "Herceptin;Alimta;Remicade", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "17/04/2014", "last_updated_date": "17/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-stolen-vials-herceptin" }, { "title": "European Medicines Agency alerts EU healthcare professionals after vials of falsified Herceptin identified", "press_release": "Yes", "related_medicine_referral": "Herceptin", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-alerts-eu-healthcare-professionals-after-vials-falsified-herceptin-identified" }, { "title": "EMA and EU national competent authorities agree on action plan to address medication errors", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/04/2014", "last_updated_date": "16/04/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-eu-national-competent-authorities-agree-action-plan-address-medication-errors" }, { "title": "European Medicines Agency closed 17-21 April 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "15/04/2014", "last_updated_date": "15/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-17-21-april-2014" }, { "title": "Update on infringement procedure against Roche Registration Ltd.", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/04/2014", "last_updated_date": "14/04/2014", "news_url": "https://www.ema.europa.eu/en/news/update-infringement-procedure-against-roche-registration-ltd" }, { "title": "Registration opens for EMA workshop on the clinical investigation of medicines for the treatment of Alzheimer's disease", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/registration-opens-ema-workshop-clinical-investigation-medicines-treatment-alzheimers-disease" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 April 2014", "press_release": "Yes", "related_medicine_referral": "Vectra Felis;Respiporc Flu3;Apoquel;Oncept IL-2;Comfortis;Porcilis ColiClos;Zuprevo;Certifect;TruScient;Porcilis Pesti;Palladia;MS-H Vaccine;Posatex;Improvac;Equip WNV (previously Duvaxyn WNV);BTVPUR AlSap 2-4;Suvaxyn PCV;Melovem;Leucogen;Leucofeligen FeLV/RCP", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-april-2014" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2014", "press_release": "No", "related_medicine_referral": "Ambroxol and bromhexine-containing medicines", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-april-2014" }, { "title": "PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-against-combined-use-medicines-affecting-renin-angiotensin-ras-system" }, { "title": "Start of review of ambroxol and bromhexine", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/start-review-ambroxol-bromhexine" }, { "title": "Start of review of codeine-containing medicines when used for cough and cold in children", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Pharmacovigilance", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/start-review-codeine-containing-medicines-when-used-cough-cold-children" }, { "title": "Review of oral methadone medicines containing povidone started", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/review-oral-methadone-medicines-containing-povidone-started" }, { "title": "Review of testosterone-containing medicines started", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/review-testosterone-containing-medicines-started" }, { "title": "Specifications for additional efficacy studies for medicines published in the Official Journal of the EU", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/04/2014", "last_updated_date": "11/04/2014", "news_url": "https://www.ema.europa.eu/en/news/specifications-additional-efficacy-studies-medicines-published-official-journal-eu" }, { "title": "EMA announces final steps for its clinical-trial data policy", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/04/2014", "last_updated_date": "08/04/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-announces-final-steps-its-clinical-trial-data-policy" }, { "title": "EMA and Australian regulator strengthen collaboration in the area of orphan medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/04/2014", "last_updated_date": "07/04/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-australian-regulator-strengthen-collaboration-area-orphan-medicines" }, { "title": "World Health Day 2014: focus on diseases transmitted by vectors", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/04/2014", "last_updated_date": "04/04/2014", "news_url": "https://www.ema.europa.eu/en/news/world-health-day-2014-focus-diseases-transmitted-vectors" }, { "title": "EMA confirms withdrawal of two court cases concerning access to clinical-trial data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/04/2014", "last_updated_date": "03/04/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-confirms-withdrawal-two-court-cases-concerning-access-clinical-trial-data" }, { "title": "European Medicines Agency introduces new fee incentives for SMEs for post-authorisation activities", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines;SME", "news_summary": "", "first_published_date": "01/04/2014", "last_updated_date": "01/04/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-introduces-new-fee-incentives-smes-post-authorisation-activities" }, { "title": "Increased fees coming into effect on 1 April 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/04/2014", "last_updated_date": "01/04/2014", "news_url": "https://www.ema.europa.eu/en/news/increased-fees-coming-effect-1-april-2014" }, { "title": "SME workshop on quality of medicines takes place this Friday", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "01/04/2014", "last_updated_date": "01/04/2014", "news_url": "https://www.ema.europa.eu/en/news/sme-workshop-quality-medicines-takes-place-friday" }, { "title": "EMA reorganisation: changes to handling of certain evaluation procedures for human medicines to be introduced from 1 April 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/03/2014", "last_updated_date": "26/03/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-reorganisation-changes-handling-certain-evaluation-procedures-human-medicines-be-introduced-1-april-2014" }, { "title": "European Medicines Agency's Management Board endorses revised policy on handling of declarations of interests", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/03/2014", "last_updated_date": "24/03/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-endorses-revised-policy-handling-declarations-interests" }, { "title": "World TB Day – three new medicines recommended in last six months for patients with multidrug-resistant tuberculosis", "press_release": "No", "related_medicine_referral": "Sirturo;Granupas (previously Para-aminosalicylic acid Lucane);Deltyba", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/03/2014", "last_updated_date": "21/03/2014", "news_url": "https://www.ema.europa.eu/en/news/world-tb-day-three-new-medicines-recommended-last-six-months-patients-multidrug-resistant-tuberculosis" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014", "press_release": "No", "related_medicine_referral": "Entyvio;Folcepri;Tresiba;Masican;Victoza;Pegasys;Ebilfumin;Sylvant;Revinty Ellipta;Vynfinit;Olysio;Neocepri;Jardiance", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "21/03/2014", "last_updated_date": "21/03/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-march-2014" }, { "title": "EMA recommends approval of new treatment for platinum-resistant ovarian cancer together with companion diagnostic", "press_release": "Yes", "related_medicine_referral": "Vynfinit;Neocepri;Folcepri", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/03/2014", "last_updated_date": "21/03/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-approval-new-treatment-platinum-resistant-ovarian-cancer-together-companion-diagnostic" }, { "title": "European Medicines Agency recommends authorisation of first medicine for Castleman's disease", "press_release": "Yes", "related_medicine_referral": "Sylvant", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/03/2014", "last_updated_date": "21/03/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-first-medicine-castlemans-disease" }, { "title": "European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease", "press_release": "Yes", "related_medicine_referral": "Entyvio", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/03/2014", "last_updated_date": "21/03/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-locally-targeted-treatment-ulcerative-colitis-crohns-disease" }, { "title": "Regulatory information - EMA issues recommendations for 2014/2015 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/03/2014", "last_updated_date": "21/03/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-issues-recommendations-2014-2015-seasonal-flu-vaccine-composition" }, { "title": "CMDh endorses recommendations to restrict the use of diacerein-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/03/2014", "last_updated_date": "21/03/2014", "news_url": "https://www.ema.europa.eu/en/news/cmdh-endorses-recommendations-restrict-use-diacerein-containing-medicines" }, { "title": "European Medicines Agency launches adaptive licensing pilot project", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/03/2014", "last_updated_date": "19/03/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-adaptive-licensing-pilot-project" }, { "title": "EMA publishes its work programme for 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/03/2014", "last_updated_date": "19/03/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-publishes-its-work-programme-2014" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 March 2014", "press_release": "Yes", "related_medicine_referral": "Versican Plus DHPPi/L4;Versican Plus DHPPi/L4R;Veraflox;Vaxxitek HVT+IBD;Respiporc Flu3;Recuvyra;Purevax Rabies;Purevax FeLV;Procox;Nobilis IB 4-91;Econor;Incurin;Comfortis;Aivlosin;Previcox;Equioxx;Aftovaxpur DOE", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/03/2014", "last_updated_date": "14/03/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-march-2014" }, { "title": "European Medicines Agency publishes first summary of a risk-management plan for a medicine", "press_release": "No", "related_medicine_referral": "Neuraceq", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "11/03/2014", "last_updated_date": "11/03/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-first-summary-risk-management-plan-medicine" }, { "title": "Joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop takes place today", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases;Rare diseases", "news_summary": "", "first_published_date": "10/03/2014", "last_updated_date": "10/03/2014", "news_url": "https://www.ema.europa.eu/en/news/joint-ema-fda-mhlw-pmda-orphan-medicinal-product-workshop-takes-place-today" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 March 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/03/2014", "last_updated_date": "07/03/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-march-2014" }, { "title": "PRAC recommends restricting use of domperidone", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/03/2014", "last_updated_date": "07/03/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-restricting-use-domperidone" }, { "title": "PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/03/2014", "last_updated_date": "07/03/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-product-information-zolpidem-be-updated-new-advice-minimise-risk-next-morning-impaired-driving-ability-mental-alertness" }, { "title": "PRAC re-examines diacerein and recommends that it remain available with restrictions", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/03/2014", "last_updated_date": "07/03/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-re-examines-diacerein-recommends-it-remain-available-restrictions" }, { "title": "EMA and FDA extend pilot programme for parallel assessment of quality-by-design applications", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "06/03/2014", "last_updated_date": "06/03/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-fda-extend-pilot-programme-parallel-assessment-quality-design-applications" }, { "title": "Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/03/2014", "last_updated_date": "03/03/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-european-medicines-agency-1-april-2014" }, { "title": "Rare Disease Day 2014 – twelve new orphan medicines available to patients over the past year", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "25/02/2014", "last_updated_date": "25/02/2014", "news_url": "https://www.ema.europa.eu/en/news/rare-disease-day-2014-twelve-new-orphan-medicines-available-patients-over-past-year" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 February 2014", "press_release": "No", "related_medicine_referral": "Firazyr;Reasanz;Nerventra;Vokanamet;Vimizim;Ulunar Breezhaler;Pregabalin Viatris Pharma (previously Pregabalin Pfizer);Hemangiol;Incruse Ellipta (previously Incruse);BiResp Spiromax;DuoResp Spiromax;Laventair Ellipta (previously Laventair);Anoro Ellipta (previously Anoro);Masiviera;Translarna", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "21/02/2014", "last_updated_date": "21/02/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-february-2014" }, { "title": "European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions", "press_release": "Yes", "related_medicine_referral": "Protelos;Osseor", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/02/2014", "last_updated_date": "21/02/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-protelos-osseor-remain-available-further-restrictions" }, { "title": "European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C", "press_release": "Yes", "related_medicine_referral": "Sovaldi", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/02/2014", "last_updated_date": "21/02/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-advises-compassionate-use-new-combination-therapy-chronic-hepatitis-c" }, { "title": "European Medicines Agency gives second positive opinion for a paediatric-use marketing authorisation", "press_release": "Yes", "related_medicine_referral": "Hemangiol", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/02/2014", "last_updated_date": "21/02/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-second-positive-opinion-paediatric-use-marketing-authorisation" }, { "title": "European Medicines Agency recommends restricting the use of methysergide-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/02/2014", "last_updated_date": "21/02/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-methysergide-containing-medicines" }, { "title": "European Medicines Agency and US Food and Drug Administration strengthen collaboration in pharmacovigilance area", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/02/2014", "last_updated_date": "19/02/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-strengthen-collaboration-pharmacovigilance-area" }, { "title": "European Medicines Agency welcomes new Head of IT Development Department", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2014", "last_updated_date": "17/02/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-it-development-department" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 February 2014", "press_release": "Yes", "related_medicine_referral": "Parvoduk;Suprelorin;Zulvac 1+8 Ovis;Zulvac 1+8 Bovis;Nobivac Myxo-RHD;Netvax;Bovalto Ibraxion;Ecoporc Shiga;Comfortis;CaniLeish;Bovilis BTV8;Bluevac BTV (previously Bluevac BTV8);Equilis StrepE;Improvac;BTVPUR AlSap 2-4;Profender", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/02/2014", "last_updated_date": "14/02/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-february-2014" }, { "title": "Committee for advanced therapies – election of new chair, overview of 2013 and looking ahead", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Innovation", "news_summary": "", "first_published_date": "14/02/2014", "last_updated_date": "14/02/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-election-new-chair-overview-2013-looking-ahead" }, { "title": "Regulatory information - use of eSubmission Gateway and web client extended to new procedure types from 1 April 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/02/2014", "last_updated_date": "14/02/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-use-esubmission-gateway-web-client-extended-new-procedure-types-1-april-2014" }, { "title": "Regulatory information – EMA introduces product numbers to track medicines through pre-authorisation procedures", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/02/2014", "last_updated_date": "11/02/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-introduces-product-numbers-track-medicines-through-pre-authorisation-procedures" }, { "title": "Regulatory information - EMA clarifies interpretation of new variation classification categories", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/02/2014", "last_updated_date": "10/02/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-clarifies-interpretation-new-variation-classification-categories" }, { "title": "European Medicines Agency updates guidance for annual strain change of seasonal influenza vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/02/2014", "last_updated_date": "07/02/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-guidance-annual-strain-change-seasonal-influenza-vaccines" }, { "title": "Regulatory information - eSubmission Gateway or web client mandatory for all eCTD submissions through the centralised procedure from 1 March 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/02/2014", "last_updated_date": "07/02/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-esubmission-gateway-or-web-client-mandatory-all-ectd-submissions-through-centralised-procedure-1-march-2014" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 February 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/02/2014", "last_updated_date": "07/02/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-february-2014" }, { "title": "Committee for orphan medicines – overview of 2013 and looking ahead", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "03/02/2014", "last_updated_date": "03/02/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicines-overview-2013-looking-ahead" }, { "title": "Regulatory information - EMA announces next steps for the maintenance of information on authorised medicines by marketing-authorisation holders", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/01/2014", "last_updated_date": "31/01/2014", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-announces-next-steps-maintenance-information-authorised-medicines-marketing-authorisation-holders" }, { "title": "Who are the originators of innovative medicines in the EU?", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Innovation", "news_summary": "", "first_published_date": "31/01/2014", "last_updated_date": "31/01/2014", "news_url": "https://www.ema.europa.eu/en/news/who-are-originators-innovative-medicines-eu" }, { "title": "EMA releases guidance on the use of pharmacogenomics to improve safety monitoring of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "30/01/2014", "last_updated_date": "30/01/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-releases-guidance-use-pharmacogenomics-improve-safety-monitoring-medicines" }, { "title": "European Medicines Agency publishes minutes of CHMP, CVMP and CAT meetings for the first time", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies;Medicines", "news_summary": "", "first_published_date": "28/01/2014", "last_updated_date": "28/01/2014", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-minutes-chmp-cvmp-cat-meetings-first-time" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 2014", "press_release": "No", "related_medicine_referral": "Adempas;Eperzan;Luminity;Vibativ;ellaOne;Winfuran;Reasanz;Zoledronic acid Teva Generics;Translarna;Masiviera;Nerventra;Osseor;Protelos;Xolair;Stelara;NovoThirteen;Kolbam;Rivastigmine 3M Health Care Ltd;Latuda;Bemfola", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "24/01/2014", "last_updated_date": "24/01/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-january-2014" }, { "title": "Review of emergency contraceptives started", "press_release": "Yes", "related_medicine_referral": "ellaOne", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/01/2014", "last_updated_date": "24/01/2014", "news_url": "https://www.ema.europa.eu/en/news/review-emergency-contraceptives-started" }, { "title": "EMA recommends 81 medicines for marketing authorisation in 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/01/2014", "last_updated_date": "20/01/2014", "news_url": "https://www.ema.europa.eu/en/news/ema-recommends-81-medicines-marketing-authorisation-2013" }, { "title": "Trends in initial evaluation of veterinary medicines by EMA in 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/01/2014", "last_updated_date": "20/01/2014", "news_url": "https://www.ema.europa.eu/en/news/trends-initial-evaluation-veterinary-medicines-ema-2013" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 January 2014", "press_release": "Yes", "related_medicine_referral": "Fungitraxx;Gripovac 3;Equisolon;Semintra;RevitaCAM;Proteq West Nile;Pexion;Zulvac 1 Ovis;Zulvac 1 Bovis;Neocolipor;Melosus;Kexxtone;Clomicalm;Cardalis;Activyl;Neocolipor;Loxicom;BTVPUR Alsap 8;Bovilis BTV8;MS-H Vaccine;Panacur AquaSol", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/01/2014", "last_updated_date": "17/01/2014", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-january-2014" }, { "title": "PRAC recommends suspending use of Protelos/Osseor", "press_release": "Yes", "related_medicine_referral": "Protelos;Osseor", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/01/2014", "last_updated_date": "10/01/2014", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-suspending-use-protelos-osseor" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2014", "press_release": "No", "related_medicine_referral": "Protelos;Osseor", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "10/01/2014", "last_updated_date": "10/01/2014", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-6-9-january-2014" }, { "title": "Looking back at 2013 - from Guido Rasi, Executive Director", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/12/2013", "last_updated_date": "20/12/2013", "news_url": "https://www.ema.europa.eu/en/news/looking-back-2013-guido-rasi-executive-director" }, { "title": "The European Medicines Agency recommends that estradiol-containing creams Linoladiol N and Linoladiol HN remain available", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/12/2013", "last_updated_date": "20/12/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-estradiol-containing-creams-linoladiol-n-linoladiol-hn-remain-available" }, { "title": "European Medicines Agency recommends approval of a new medicine for multidrug-resistant tuberculosis", "press_release": "Yes", "related_medicine_referral": "Sirturo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/12/2013", "last_updated_date": "20/12/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-new-medicine-multidrug-resistant-tuberculosis" }, { "title": "CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen", "press_release": "Yes", "related_medicine_referral": "Kogenate Bayer;Helixate NexGen", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "20/12/2013", "last_updated_date": "20/12/2013", "news_url": "https://www.ema.europa.eu/en/news/chmp-confirms-prac-recommendations-kogenate-bayer-helixate-nexgen" }, { "title": "Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/12/2013", "last_updated_date": "20/12/2013", "news_url": "https://www.ema.europa.eu/en/news/acipimox-only-be-used-additional-or-alternative-treatment-reduce-high-triglyceride-levels" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 December 2013", "press_release": "No", "related_medicine_referral": "Jentadueto;Winfuran;Izba;Sirturo;Neuraceq;Mirvaso;Cometriq;Prometax;Exelon;Masican;Helixate NexGen;Kogenate Bayer", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/12/2013", "last_updated_date": "20/12/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-december-2013" }, { "title": "Registration opens for joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases;Rare diseases", "news_summary": "", "first_published_date": "19/12/2013", "last_updated_date": "19/12/2013", "news_url": "https://www.ema.europa.eu/en/news/registration-opens-joint-ema-fda-mhlw-pmda-orphan-medicinal-product-workshop" }, { "title": "European Medicines Agency closed 23 December 2013 to 2 January 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/12/2013", "last_updated_date": "19/12/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-23-december-2013-2-january-2014" }, { "title": "European Medicines Agency and FDA announce launch of generic medicines application inspections initiative", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections;Generic and hybrid medicines;Medicines", "news_summary": "", "first_published_date": "18/12/2013", "last_updated_date": "18/12/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-fda-announce-launch-generic-medicines-application-inspections-initiative" }, { "title": "Statements of non-compliance with GMP now publicly available in EudraGMDP", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "18/12/2013", "last_updated_date": "18/12/2013", "news_url": "https://www.ema.europa.eu/en/news/statements-non-compliance-gmp-now-publicly-available-eudragmdp" }, { "title": "European Medicines Agency now publishing meeting agendas for all scientific committees", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "17/12/2013", "last_updated_date": "17/12/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-now-publishing-meeting-agendas-all-scientific-committees" }, { "title": "European Medicines Agency's Management Board endorses work programme 2014", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/12/2013", "last_updated_date": "17/12/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-endorses-work-programme-2014" }, { "title": "European Medicines Agency to push ahead in 2014 towards publication and access to clinical trial data", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "17/12/2013", "last_updated_date": "17/12/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-push-ahead-2014-towards-publication-access-clinical-trial-data" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 December 2013", "press_release": "Yes", "related_medicine_referral": "NexGard;Bravecto;Emdocam;Reconcile;Cimalgex;Activyl Tick Plus;Zulvac 8 Ovis;Zulvac 8 Bovis;Rheumocam;Startvac;Novem;Metacam;Fevaxyn Pentofel;Contacera", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/12/2013", "last_updated_date": "13/12/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-december-2013" }, { "title": "EMA publishes report on workshop on regulatory options in the fight against antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/12/2013", "last_updated_date": "12/12/2013", "news_url": "https://www.ema.europa.eu/en/news/ema-publishes-report-workshop-regulatory-options-fight-against-antimicrobial-resistance" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 December 2013", "press_release": "No", "related_medicine_referral": "Kogenate Bayer;Helixate NexGen;Iclusig", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "06/12/2013", "last_updated_date": "06/12/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-december-2013" }, { "title": "PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients", "press_release": "Yes", "related_medicine_referral": "Kogenate Bayer;Helixate NexGen", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "06/12/2013", "last_updated_date": "06/12/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-considers-benefits-kogenate-bayer-helixate-nexgen-outweigh-risks-previously-untreated-patients" }, { "title": "Further review of Iclusig started", "press_release": "Yes", "related_medicine_referral": "Iclusig", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "06/12/2013", "last_updated_date": "06/12/2013", "news_url": "https://www.ema.europa.eu/en/news/further-review-iclusig-started" }, { "title": "European Medicines Agency applies greater fee-reduction rates for orphan medicines in 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/12/2013", "last_updated_date": "03/12/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-applies-greater-fee-reduction-rates-orphan-medicines-2014" }, { "title": "Regulatory information – adjustment of linguistic review timetable for opinions adopted at December CHMP meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/12/2013", "last_updated_date": "02/12/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-adjustment-linguistic-review-timetable-opinions-adopted-december-chmp-meeting" }, { "title": "European Medicines Agency website unavailable Sunday 1 December 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/11/2013", "last_updated_date": "29/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-sunday-1-december-2013" }, { "title": "European Medicines Agency closed 23 December 2013 to 2 January 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/11/2013", "last_updated_date": "29/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-23-december-2013-2-january-2014-0" }, { "title": "Early dialogue between regulators and health technology assessment bodies key to medicines development", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/11/2013", "last_updated_date": "28/11/2013", "news_url": "https://www.ema.europa.eu/en/news/early-dialogue-between-regulators-health-technology-assessment-bodies-key-medicines-development" }, { "title": "World AIDS Day 2013 – Revised guidance to facilitate development of new medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/11/2013", "last_updated_date": "28/11/2013", "news_url": "https://www.ema.europa.eu/en/news/world-aids-day-2013-revised-guidance-facilitate-development-new-medicines" }, { "title": "European SME Week – early dialogue with the EMA is key to success", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "26/11/2013", "last_updated_date": "26/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-sme-week-early-dialogue-ema-key-success" }, { "title": "Launch of European project for monitoring benefits and risks of vaccines throughout their lifecycle", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/11/2013", "last_updated_date": "26/11/2013", "news_url": "https://www.ema.europa.eu/en/news/launch-european-project-monitoring-benefits-risks-vaccines-throughout-their-lifecycle" }, { "title": "EMA-HTA workshop on parallel scientific advice in drug development takes place today", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/11/2013", "last_updated_date": "26/11/2013", "news_url": "https://www.ema.europa.eu/en/news/ema-hta-workshop-parallel-scientific-advice-drug-development-takes-place-today" }, { "title": "EMA-HTA workshop on parallel scientific advice in drug development to take place tomorrow", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/11/2013", "last_updated_date": "25/11/2013", "news_url": "https://www.ema.europa.eu/en/news/ema-hta-workshop-parallel-scientific-advice-drug-development-take-place-tomorrow" }, { "title": "European SME Week - supporting a major driver of innovation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "25/11/2013", "last_updated_date": "25/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-sme-week-supporting-major-driver-innovation" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 2013", "press_release": "No", "related_medicine_referral": "Abraxane;Pradaxa;Granupas (previously Para-aminosalicylic acid Lucane);Zoledronic Acid Accord;Masican;Xigduo;Tivicay;Kolbam;Sovaldi;Deltyba;Procoralan;Tecfidera;Erbitux;Velcade;Corlentor", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-november-2013" }, { "title": "Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks-chmp-endorses-prac-recommendation" }, { "title": "European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots", "press_release": "Yes", "related_medicine_referral": "Iclusig", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-changes-use-leukaemia-medicine-iclusig-ponatinib-order-minimise-risk-blood-clots" }, { "title": "European Medicines Agency recommends approval of new HIV medicine", "press_release": "Yes", "related_medicine_referral": "Tivicay", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-new-hiv-medicine" }, { "title": "European Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection" }, { "title": "European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C", "press_release": "Yes", "related_medicine_referral": "Sovaldi", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-sofosbuvir-treatment-chronic-hepatitis-c" }, { "title": "European Medicines Agency advises on compassionate use of daclatasvir", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-advises-compassionate-use-daclatasvir" }, { "title": "European Medicines Agency recommends two new treatment options for tuberculosis", "press_release": "Yes", "related_medicine_referral": "Granupas (previously Para-aminosalicylic acid Lucane);Deltyba", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-two-new-treatment-options-tuberculosis" }, { "title": "European Medicines Agency recommends extending use of Abraxane to include treatment of pancreatic cancer", "press_release": "Yes", "related_medicine_referral": "Abraxane", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/11/2013", "last_updated_date": "22/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-extending-use-abraxane-include-treatment-pancreatic-cancer" }, { "title": "European Medicines Agency's Committee on Herbal Medicinal Products elects new chair and vice-chair", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "Medicines", "news_summary": "", "first_published_date": "20/11/2013", "last_updated_date": "20/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-committee-herbal-medicinal-products-elects-new-chair-vice-chair" }, { "title": "European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection", "press_release": "Yes", "related_medicine_referral": "Avastin;Zelboraf;Xenical;Xeloda;Viracept;Tarceva;Tamiflu;RoActemra;Pegasys;NeoRecormon;Mircera;MabThera;Invirase;Herceptin;Fuzeon;CellCept;Bonviva;Bondronat;Bondenza (previously Ibandronic Acid Roche)", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/11/2013", "last_updated_date": "19/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-review-medicines-concerned-roche-pharmacovigilance-inspection" }, { "title": "European Medicines Agency and EUnetHTA agree joint work plan", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/11/2013", "last_updated_date": "19/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-eunethta-agree-joint-work-plan" }, { "title": "Regulatory information - EMA encourages companies to submit quality type-I variations for 2013 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/11/2013", "last_updated_date": "18/11/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-encourages-companies-submit-quality-type-i-variations-2013-end-november-0" }, { "title": "European Antibiotic Awareness Day 2013: 'Everyone is responsible'", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/11/2013", "last_updated_date": "18/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-2013-everyone-responsible" }, { "title": "EMA promotes consistent development of bioequivalence studies through product-specific guidance", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/11/2013", "last_updated_date": "15/11/2013", "news_url": "https://www.ema.europa.eu/en/news/ema-promotes-consistent-development-bioequivalence-studies-through-product-specific-guidance" }, { "title": "Mitigating risk aversion in medicines regulation in the interest of public health", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/11/2013", "last_updated_date": "15/11/2013", "news_url": "https://www.ema.europa.eu/en/news/mitigating-risk-aversion-medicines-regulation-interest-public-health" }, { "title": "EMA provides guidance on development of medicines to prevent stroke in patients with atrial fibrillation – comments invited", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/11/2013", "last_updated_date": "15/11/2013", "news_url": "https://www.ema.europa.eu/en/news/ema-provides-guidance-development-medicines-prevent-stroke-patients-atrial-fibrillation-comments-invited" }, { "title": "World Diabetes Day – more treatment options to meet needs of growing patient numbers", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "14/11/2013", "last_updated_date": "14/11/2013", "news_url": "https://www.ema.europa.eu/en/news/world-diabetes-day-more-treatment-options-meet-needs-growing-patient-numbers" }, { "title": "European Medicines Agency updates on development of its policy on publication and access to clinical-trial data", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "13/11/2013", "last_updated_date": "13/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-development-its-policy-publication-access-clinical-trial-data" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 5-7 November 2013", "press_release": "Yes", "related_medicine_referral": "Suvaxyn PCV;Leucofeligen FeLV/RCP;Recuvyra;Prac-tic;Poulvac E. coli;Novem;Nobivac L4;Metacam;Hiprabovis IBR Marker Live;Equioxx;Equilis Prequenza Te;Equilis Prequenza;Cerenia;BTVPUR;Bluevac BTV (previously Bluevac BTV8);MS-H Vaccine;Zolvix;Leucogen", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/11/2013", "last_updated_date": "08/11/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-november-2013" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 November 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "08/11/2013", "last_updated_date": "08/11/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-november-2013" }, { "title": "PRAC recommends suspension of diacerein-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "08/11/2013", "last_updated_date": "08/11/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-suspension-diacerein-containing-medicines" }, { "title": "PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "08/11/2013", "last_updated_date": "08/11/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-using-acipimox-only-additional-or-alternative-treatment-lower-high-triglyceride-levels" }, { "title": "PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig", "press_release": "Yes", "related_medicine_referral": "Iclusig", "categories": "Corporate", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "08/11/2013", "last_updated_date": "08/11/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-updates-risks-serious-vascular-occlusive-events-associated-cancer-medicine-iclusig" }, { "title": "Briefing meetings of the EMA Innovation Task Force now open to veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Innovation", "news_summary": "", "first_published_date": "08/11/2013", "last_updated_date": "08/11/2013", "news_url": "https://www.ema.europa.eu/en/news/briefing-meetings-ema-innovation-task-force-now-open-veterinary-medicines" }, { "title": "European Medicines Agency website unavailable Saturday 9 November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "08/11/2013", "last_updated_date": "08/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-saturday-9-november" }, { "title": "Workshop on regulatory options in fight against antimicrobial resistance takes place today", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/11/2013", "last_updated_date": "08/11/2013", "news_url": "https://www.ema.europa.eu/en/news/workshop-regulatory-options-fight-against-antimicrobial-resistance-takes-place-today" }, { "title": "New EMA guidance on development of antibacterials to help in the fight against multidrug-resistant pathogens", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "07/11/2013", "last_updated_date": "07/11/2013", "news_url": "https://www.ema.europa.eu/en/news/new-ema-guidance-development-antibacterials-help-fight-against-multidrug-resistant-pathogens" }, { "title": "European Medicines Agency launches public catalogue of medicine shortages assessed by the Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "04/11/2013", "last_updated_date": "04/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-public-catalogue-medicine-shortages-assessed-agency" }, { "title": "European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "04/11/2013", "last_updated_date": "04/11/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-release-further-guidance-quality-design-approach" }, { "title": "Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders and changes to scope of European safety referrals", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/10/2013", "last_updated_date": "31/10/2013", "news_url": "https://www.ema.europa.eu/en/news/amendments-pharmacovigilance-legislation-new-notification-requirements-marketing-authorisation-holders-changes-scope-european-safety-referrals" }, { "title": "Comments invited on concept paper on the need to revise the guideline on medicines to treat Alzheimer's disease", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "31/10/2013", "last_updated_date": "31/10/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-concept-paper-need-revise-guideline-medicines-treat-alzheimers-disease" }, { "title": "Workshop on biosimilars takes place today", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Biosimilars", "news_summary": "", "first_published_date": "31/10/2013", "last_updated_date": "31/10/2013", "news_url": "https://www.ema.europa.eu/en/news/workshop-biosimilars-takes-place-today" }, { "title": "European Medicines Agency closed on 1 November 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "30/10/2013", "last_updated_date": "30/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-november-2013" }, { "title": "European Medicines Agency explores ways to further involve patients in the benefit-risk assessment of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/10/2013", "last_updated_date": "29/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-explores-ways-further-involve-patients-benefit-risk-assessment-medicines" }, { "title": "Revision of paediatric-investigation-plan guideline: stakeholder comments sought by European Commission", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "28/10/2013", "last_updated_date": "28/10/2013", "news_url": "https://www.ema.europa.eu/en/news/revision-paediatric-investigation-plan-guideline-stakeholder-comments-sought-european-commission" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 2013", "press_release": "No", "related_medicine_referral": "Brintellix;Opsumit;Xgeva;Pandemic Influenza Vaccine H5N1 Baxter AG;Cimzia;Synflorix;Vepacel;Eviplera;Levetiracetam Hospira", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "25/10/2013", "last_updated_date": "25/10/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-october-2013" }, { "title": "European Medicines Agency gives recommendations on the use of intravenous nicardipine", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/10/2013", "last_updated_date": "25/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine" }, { "title": "Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled", "press_release": "Yes", "related_medicine_referral": "NovoMix", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/10/2013", "last_updated_date": "25/10/2013", "news_url": "https://www.ema.europa.eu/en/news/batches-insulin-medicine-novomix-30-flexpen-penfill-be-recalled" }, { "title": "European Medicines Agency advises on compassionate use of sofosbuvir", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/10/2013", "last_updated_date": "25/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-advises-compassionate-use-sofosbuvir" }, { "title": "Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "25/10/2013", "last_updated_date": "25/10/2013", "news_url": "https://www.ema.europa.eu/en/news/hydroxyethyl-starch-solutions-hes-should-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients-cmdh-endorses-prac-recommendations" }, { "title": "Restrictions on use of short-acting beta-agonists in obstetric indications – CMDh endorses PRAC recommendations", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "25/10/2013", "last_updated_date": "25/10/2013", "news_url": "https://www.ema.europa.eu/en/news/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations" }, { "title": "How access to full clinical-trial data sets will benefit medicines developers", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/10/2013", "last_updated_date": "22/10/2013", "news_url": "https://www.ema.europa.eu/en/news/how-access-full-clinical-trial-data-sets-will-benefit-medicines-developers" }, { "title": "Comments invited on reflection paper on risk of antimicrobial resistance transfer from companion animals to humans", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "21/10/2013", "last_updated_date": "21/10/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-reflection-paper-risk-antimicrobial-resistance-transfer-companion-animals-humans" }, { "title": "Workshop on clinical investigation of new medicines for the treatment of multiple sclerosis takes place today", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "17/10/2013", "last_updated_date": "17/10/2013", "news_url": "https://www.ema.europa.eu/en/news/workshop-clinical-investigation-new-medicines-treatment-multiple-sclerosis-takes-place-today" }, { "title": "First qualification opinion on a statistical methodology for dose finding released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "15/10/2013", "last_updated_date": "15/10/2013", "news_url": "https://www.ema.europa.eu/en/news/first-qualification-opinion-statistical-methodology-dose-finding-released-public-consultation" }, { "title": "European Medicines Agency publishes report on sales of veterinary antimicrobials in 25 countries in 2011", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "15/10/2013", "last_updated_date": "15/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-report-sales-veterinary-antimicrobials-25-countries-2011" }, { "title": "Regulatory information - EMA encourages companies to submit quality type-I variations for 2013 by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/10/2013", "last_updated_date": "14/10/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-ema-encourages-companies-submit-quality-type-i-variations-2013-end-november" }, { "title": "EMA workshop on prevention of product shortages due to manufacturing and quality problems takes place today", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/10/2013", "last_updated_date": "14/10/2013", "news_url": "https://www.ema.europa.eu/en/news/ema-workshop-prevention-product-shortages-due-manufacturing-quality-problems-takes-place-today" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 October 2013", "press_release": "Yes", "related_medicine_referral": "Aivlosin;Vectra 3D;TruScient;Panacur AquaSol;Naxcel;MS-H Vaccine;Leucofeligen FeLV/RCP;Easotic;Certifect;Porcilis PCV;Acticam;Suvaxyn PCV;Meloxidyl;Cardalis;Coxevac;Spironolactone Ceva;Broadline", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/10/2013", "last_updated_date": "11/10/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-october-2013" }, { "title": "European Medicines Agency launches a new version of EudraCT", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "11/10/2013", "last_updated_date": "11/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-new-version-eudract" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 October 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "11/10/2013", "last_updated_date": "11/10/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-october-2013" }, { "title": "PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks", "press_release": "Yes", "related_medicine_referral": "Evra;Zoely;Ioa", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "11/10/2013", "last_updated_date": "11/10/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-confirms-benefits-all-combined-hormonal-contraceptives-chcs-continue-outweigh-risks" }, { "title": "PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "11/10/2013", "last_updated_date": "11/10/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-confirms-hydroxyethyl-starch-solutions-hes-should-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients" }, { "title": "World Arthritis Day: 12 October 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/10/2013", "last_updated_date": "11/10/2013", "news_url": "https://www.ema.europa.eu/en/news/world-arthritis-day-12-october-2013" }, { "title": "EMA to host workshop on prevention of product shortages due to manufacturing and quality problems", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/10/2013", "last_updated_date": "10/10/2013", "news_url": "https://www.ema.europa.eu/en/news/ema-host-workshop-prevention-product-shortages-due-manufacturing-quality-problems" }, { "title": "World Mental Health Day: 10 October 2013", "press_release": "No", "related_medicine_referral": "Amyvid", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/10/2013", "last_updated_date": "10/10/2013", "news_url": "https://www.ema.europa.eu/en/news/world-mental-health-day-10-october-2013" }, { "title": "European Medicines Agency organises SME workshop dedicated to veterinary topics", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines;SME", "news_summary": "", "first_published_date": "09/10/2013", "last_updated_date": "09/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-organises-sme-workshop-dedicated-veterinary-topics" }, { "title": "Comments invited on draft reflection paper on data requirements for iron-based nanocolloidal products developed with reference to an innovator medicine", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "07/10/2013", "last_updated_date": "07/10/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-draft-reflection-paper-data-requirements-iron-based-nanocolloidal-products-developed-reference-innovator-medicine" }, { "title": "European Medicines Agency's Management Board supports plan to publish agendas and minutes of all committees", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/10/2013", "last_updated_date": "07/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-supports-plan-publish-agendas-minutes-all-committees" }, { "title": "EU and Japan improve information-sharing in the area of good manufacturing practice using EudraGMDP database", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "07/10/2013", "last_updated_date": "07/10/2013", "news_url": "https://www.ema.europa.eu/en/news/eu-japan-improve-information-sharing-area-good-manufacturing-practice-using-eudragmdp-database" }, { "title": "European Medicines Agency begins to publish recommendations based on safety signals", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "04/10/2013", "last_updated_date": "04/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-begins-publish-recommendations-based-safety-signals" }, { "title": "European Medicines Agency publishes report on conflicts of interests workshop", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "02/10/2013", "last_updated_date": "02/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-report-conflicts-interests-workshop" }, { "title": "Public consultation on the publication and access to clinical-trial data now closed", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/10/2013", "last_updated_date": "01/10/2013", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-publication-access-clinical-trial-data-now-closed" }, { "title": "European Medicines Agency publishes a video explaining the concept of medicines under additional monitoring", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/10/2013", "last_updated_date": "01/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-video-explaining-concept-medicines-under-additional-monitoring" }, { "title": "European Medicines Agency publishes a video explaining the concept of medicines under additional monitoring", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/10/2013", "last_updated_date": "01/10/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-video-explaining-concept-medicines-under-additional-monitoring-0" }, { "title": "Consultation on updated guideline on clinical development of medicines for treatment of HIV infection", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "30/09/2013", "last_updated_date": "30/09/2013", "news_url": "https://www.ema.europa.eu/en/news/consultation-updated-guideline-clinical-development-medicines-treatment-hiv-infection" }, { "title": "World Heart Day – more guidance for medicines developers", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/09/2013", "last_updated_date": "27/09/2013", "news_url": "https://www.ema.europa.eu/en/news/world-heart-day-more-guidance-medicines-developers" }, { "title": "European Medicines Agency to host workshop on regulatory options in the fight against antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/09/2013", "last_updated_date": "26/09/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-host-workshop-regulatory-options-fight-against-antimicrobial-resistance" }, { "title": "Committee for Advanced Therapies issues first recommendation for certification of non-clinical data for an advanced therapy", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "26/09/2013", "last_updated_date": "26/09/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-issues-first-recommendation-certification-non-clinical-data-advanced-therapy" }, { "title": "European Medicines Agency website unavailable Saturday 28 September", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/09/2013", "last_updated_date": "26/09/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-saturday-28-september" }, { "title": "European Medicines Agency organising workshop on biosimilars", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Biosimilars;Medicines", "news_summary": "", "first_published_date": "25/09/2013", "last_updated_date": "25/09/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-organising-workshop-biosimilars" }, { "title": "Working parties for healthcare professionals and for patients and consumers elect new co-chairs", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/09/2013", "last_updated_date": "25/09/2013", "news_url": "https://www.ema.europa.eu/en/news/working-parties-healthcare-professionals-patients-consumers-elect-new-co-chairs" }, { "title": "European Medicines Agency publishes CVs of experts involved in its activities", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "24/09/2013", "last_updated_date": "24/09/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-cvs-experts-involved-its-activities" }, { "title": "Call for expressions of interest to appoint patient and healthcare-professional representatives as members of Paediatric Committee", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "24/09/2013", "last_updated_date": "24/09/2013", "news_url": "https://www.ema.europa.eu/en/news/call-expressions-interest-appoint-patient-healthcare-professional-representatives-members-paediatric-committee" }, { "title": "World Alzheimer's Month - Supporting development of medicines by qualification of biomarkers", "press_release": "No", "related_medicine_referral": "Amyvid", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/09/2013", "last_updated_date": "20/09/2013", "news_url": "https://www.ema.europa.eu/en/news/world-alzheimers-month-supporting-development-medicines-qualification-biomarkers" }, { "title": "Numeta G13%E to be suspended and new risk-minimisation measures to be introduced for Numeta G16%E", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/09/2013", "last_updated_date": "20/09/2013", "news_url": "https://www.ema.europa.eu/en/news/numeta-g13e-be-suspended-new-risk-minimisation-measures-be-introduced-numeta-g16e" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013", "press_release": "No", "related_medicine_referral": "Thymanax;Ipreziv;Kineret;Kadcyla;Vitekta;Relvar Ellipta;Xofigo;Invokana;Memantine Accord;NovoEight;Fortacin;Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz);Fluenz Tetra;Abilify Maintena;Valdoxan;Votubia;Cimzia;Yervoy;Edarbi", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/09/2013", "last_updated_date": "20/09/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-september-2013" }, { "title": "European Medicines Agency website unavailable 20-22 September 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/09/2013", "last_updated_date": "19/09/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-20-22-september-2013" }, { "title": "Committee on Herbal Medicinal Products publishes its meeting agenda for the first time", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal;Herbal", "topics": "", "news_summary": "", "first_published_date": "16/09/2013", "last_updated_date": "16/09/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-herbal-medicinal-products-publishes-its-meeting-agenda-first-time" }, { "title": "European Medicines Agency reveals new structure", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/09/2013", "last_updated_date": "16/09/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reveals-new-structure" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2013", "press_release": "Yes", "related_medicine_referral": "Comfortis;Certifect;Porcilis AR-T DF;Equilis StrepE;Activyl;Zuprevo;Veraflox;ProteqFlu;Procox;Porcilis ColiClos;Inflacam;Halocur;Dicural;BTVPUR AlSap 2-4;Advocate;Acticam;Easotic;Onsior;Coxevac;Zulvac 1+8 Bovis;Respiporc Flu3;Improvac;Gripovac 3;Equip WNV (previously Duvaxyn WNV);Convenia", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/09/2013", "last_updated_date": "13/09/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-september-2013" }, { "title": "Paediatric Committee elects new Chair and Vice-Chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "13/09/2013", "last_updated_date": "13/09/2013", "news_url": "https://www.ema.europa.eu/en/news/paediatric-committee-elects-new-chair-vice-chair" }, { "title": "European Medicines Agency hears views from stakeholders on its conflicts-of-interests policy for scientific experts", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "12/09/2013", "last_updated_date": "12/09/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-hears-views-stakeholders-its-conflicts-interests-policy-scientific-experts" }, { "title": "Registration open for orphan-product-designation and -grant workshop", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/09/2013", "last_updated_date": "06/09/2013", "news_url": "https://www.ema.europa.eu/en/news/registration-open-orphan-product-designation-grant-workshop" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "06/09/2013", "last_updated_date": "06/09/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-september-2013" }, { "title": "European Medicines Agency's workshop on conflicts of interests today", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "06/09/2013", "last_updated_date": "06/09/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-workshop-conflicts-interests-today" }, { "title": "Draft policy on publication and access to clinical-trial data: one month left to send comments", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/08/2013", "last_updated_date": "30/08/2013", "news_url": "https://www.ema.europa.eu/en/news/draft-policy-publication-access-clinical-trial-data-one-month-left-send-comments" }, { "title": "European Medicines Agency closed 26 August 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/08/2013", "last_updated_date": "22/08/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-26-august-2013" }, { "title": "European Medicines Agency and US Food and Drug Administration release first conclusions of parallel assessment of quality-by-design applications", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/08/2013", "last_updated_date": "20/08/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-release-first-conclusions-parallel-assessment-quality-design-applications" }, { "title": "European Medicines Agency publishes reflection paper on general issues for consideration regarding coated nanomedicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/08/2013", "last_updated_date": "15/08/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-reflection-paper-general-issues-consideration-regarding-coated-nanomedicines" }, { "title": "Workshop on conflicts of interests: deadline for registration extended", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/08/2013", "last_updated_date": "14/08/2013", "news_url": "https://www.ema.europa.eu/en/news/workshop-conflicts-interests-deadline-registration-extended" }, { "title": "'Send a question' form working again", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/08/2013", "last_updated_date": "14/08/2013", "news_url": "https://www.ema.europa.eu/en/news/send-question-form-working-again" }, { "title": "Regulatory information - Revised dossier-submission requirements for active-substance master files", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/08/2013", "last_updated_date": "14/08/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-revised-dossier-submission-requirements-active-substance-master-files" }, { "title": "'Send a question' form not working", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/08/2013", "last_updated_date": "09/08/2013", "news_url": "https://www.ema.europa.eu/en/news/send-question-form-not-working" }, { "title": "Regulatory information - European Medicines Agency publishes guidance on validation process for initial marketing authorisation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "05/08/2013", "last_updated_date": "05/08/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-european-medicines-agency-publishes-guidance-validation-process-initial-marketing-authorisation" }, { "title": "Guideline on medicines for the treatment of amyotrophic lateral sclerosis released for a six-month public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/08/2013", "last_updated_date": "01/08/2013", "news_url": "https://www.ema.europa.eu/en/news/guideline-medicines-treatment-amyotrophic-lateral-sclerosis-released-six-month-public-consultation" }, { "title": "Concept paper on development of product-specific guidance on demonstration of bioequivalence released for a two-month public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/08/2013", "last_updated_date": "01/08/2013", "news_url": "https://www.ema.europa.eu/en/news/concept-paper-development-product-specific-guidance-demonstration-bioequivalence-released-two-month-public-consultation" }, { "title": "Regulatory information - European Medicines Agency introduces digital signatures for selected procedures", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/08/2013", "last_updated_date": "01/08/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-european-medicines-agency-introduces-digital-signatures-selected-procedures" }, { "title": "Update on reshaping the organisation of the European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/08/2013", "last_updated_date": "01/08/2013", "news_url": "https://www.ema.europa.eu/en/news/update-reshaping-organisation-european-medicines-agency" }, { "title": "European Medicines Agency recommends approval of 44 medicines for human use and six medicines for veterinary use in first half 2013", "press_release": "No", "related_medicine_referral": "Provenge;Bosulif;Imvanex;Lojuxta;Iclusig", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "31/07/2013", "last_updated_date": "31/07/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-44-medicines-human-use-six-medicines-veterinary-use-first-half-2013" }, { "title": "Comments invited on draft revised guideline on medicines for the treatment of hypertension", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "31/07/2013", "last_updated_date": "31/07/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-draft-revised-guideline-medicines-treatment-hypertension" }, { "title": "EMA's Head of Human Medicines Development and Evaluation Patrick Le Courtois retires after 16 years of service", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "31/07/2013", "last_updated_date": "31/07/2013", "news_url": "https://www.ema.europa.eu/en/news/emas-head-human-medicines-development-evaluation-patrick-le-courtois-retires-after-16-years-service" }, { "title": "Regulatory information - European Medicines Agency revises rules on fees", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "31/07/2013", "last_updated_date": "31/07/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-european-medicines-agency-revises-rules-fees" }, { "title": "Antimicrobial resistance - European Medicines Agency provides advice on use of colistin and tigecycline in animals", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Antimicrobial resistance;Medicines", "news_summary": "", "first_published_date": "30/07/2013", "last_updated_date": "30/07/2013", "news_url": "https://www.ema.europa.eu/en/news/antimicrobial-resistance-european-medicines-agency-provides-advice-use-colistin-tigecycline-animals" }, { "title": "World Hepatitis Day: 28 July 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/07/2013", "last_updated_date": "26/07/2013", "news_url": "https://www.ema.europa.eu/en/news/world-hepatitis-day-28-july-2013" }, { "title": "2012 annual report on EudraVigilance published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/07/2013", "last_updated_date": "26/07/2013", "news_url": "https://www.ema.europa.eu/en/news/2012-annual-report-eudravigilance-published" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013", "press_release": "No", "related_medicine_referral": "Ilaris;Prezista;Defitelio;Deltyba;Grastofil;Tybost;Xoterna Breezhaler;Ultibro Breezhaler;Vipidia;Vipdomet;Giotrif;Zomarist;Xiliarx;Jalra;Icandra (previously Vildagliptin / metformin hydrochloride Novartis);Galvus;Eucreas;Jentadueto;Onglyza;Komboglyze;Ristfor;Xelevia;Ristaben;Trajenta;Velmetia;Tesavel;Janumet;Januvia;Efficib;Lyxumia;Bydureon;Victoza;Byetta;Revolade;Eylea;Xeljanz;Eviplera;Effentora;Incresync;Insuman;Zonegran;Stelara;Simponi", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/07/2013", "last_updated_date": "26/07/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2013" }, { "title": "European Medicines Agency recommends changes to the use of metoclopramide", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/07/2013", "last_updated_date": "26/07/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-changes-use-metoclopramide" }, { "title": "Investigation into GLP-1-based diabetes therapies concluded", "press_release": "Yes", "related_medicine_referral": "Byetta;Bydureon;Zomarist;Xiliarx;Jalra;Icandra (previously Vildagliptin / metformin hydrochloride Novartis);Galvus;Eucreas;Jentadueto;Onglyza;Komboglyze;Ristfor;Xelevia;Ristaben;Trajenta;Velmetia;Tesavel;Janumet;Januvia;Efficib;Lyxumia;Victoza", "categories": "Human", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "26/07/2013", "last_updated_date": "26/07/2013", "news_url": "https://www.ema.europa.eu/en/news/investigation-glp-1-based-diabetes-therapies-concluded" }, { "title": "European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/07/2013", "last_updated_date": "26/07/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisations-oral-ketoconazole" }, { "title": "Regulatory information - Revision of procedural guidance to reflect update of variations guidelines from the European Commission", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "25/07/2013", "last_updated_date": "25/07/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-revision-procedural-guidance-reflect-update-variations-guidelines-european-commission" }, { "title": "Pharmacovigilance Risk Assessment Committee: one year of public-health promotion and protection", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "19/07/2013", "last_updated_date": "19/07/2013", "news_url": "https://www.ema.europa.eu/en/news/pharmacovigilance-risk-assessment-committee-one-year-public-health-promotion-protection" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2013", "press_release": "Yes", "related_medicine_referral": "Melovem;Advocate;Nobivac L4;Apoquel;Trifexis;Nobivac Myxo-RHD;Zulvac 1 Ovis;Zulvac 1 Bovis;Rhiniseng;RevitaCAM;Reconcile;Purevax Rabies;Proteq West Nile;Nobilis Influenza H5N2;Dexdomitor;Coxevac;Cimalgex;Cerenia;Masivet;Equip WNV (previously Duvaxyn WNV);Suvaxyn PCV;Nobivac L4;Cerenia", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/07/2013", "last_updated_date": "19/07/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-16-18-july-2013" }, { "title": "European Medicines Agency publishes agenda for workshop on conflicts of interests on 6 September 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/07/2013", "last_updated_date": "19/07/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-agenda-workshop-conflicts-interests-6-september-2013" }, { "title": "Guideline on medicines for the treatment of irritable bowel syndrome released for a six-month public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/07/2013", "last_updated_date": "19/07/2013", "news_url": "https://www.ema.europa.eu/en/news/guideline-medicines-treatment-irritable-bowel-syndrome-released-six-month-public-consultation" }, { "title": "Regulatory information - Updated variations application form for human and veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/07/2013", "last_updated_date": "19/07/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-updated-variations-application-form-human-veterinary-medicines" }, { "title": "European Medicines Agency welcomes new Head of Legal Service", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "18/07/2013", "last_updated_date": "18/07/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-legal-service" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/07/2013", "last_updated_date": "12/07/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-july-2013" }, { "title": "Regulatory information – European Medicines Agency organises training sessions on eSubmission Gateway and web client for PSUR single-assessment submissions", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "11/07/2013", "last_updated_date": "11/07/2013", "news_url": "https://www.ema.europa.eu/en/news/regulatory-information-european-medicines-agency-organises-training-sessions-esubmission-gateway-web-client-psur-single-assessment-submissions" }, { "title": "European Medicines Agency creates Healthcare Professionals' Working Party", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "09/07/2013", "last_updated_date": "09/07/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-creates-healthcare-professionals-working-party" }, { "title": "Registration opens for workshop on conflicts of interests", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/07/2013", "last_updated_date": "05/07/2013", "news_url": "https://www.ema.europa.eu/en/news/registration-opens-workshop-conflicts-interests" }, { "title": "ENCePP guide on methodological standards in pharmacoepidemiology revised", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/07/2013", "last_updated_date": "03/07/2013", "news_url": "https://www.ema.europa.eu/en/news/encepp-guide-methodological-standards-pharmacoepidemiology-revised" }, { "title": "Falsified Medicines Directive: Imported active substances need written confirmation to guarantee GMP standards", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "02/07/2013", "last_updated_date": "02/07/2013", "news_url": "https://www.ema.europa.eu/en/news/falsified-medicines-directive-imported-active-substances-need-written-confirmation-guarantee-gmp-standards" }, { "title": "Comments invited on guidance on clinical investigation of medicines for the treatment of asthma", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/07/2013", "last_updated_date": "01/07/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-guidance-clinical-investigation-medicines-treatment-asthma" }, { "title": "Croatia becomes a new member of the European medicines network", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/07/2013", "last_updated_date": "01/07/2013", "news_url": "https://www.ema.europa.eu/en/news/croatia-becomes-new-member-european-medicines-network" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2013", "press_release": "No", "related_medicine_referral": "Aprovel;CoAprovel;Velcade;Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop);Vectibix;Vectibix;Tyverb;Onglyza;Evicel;Karvezide;Karvea;Exforge HCT;Irbesartan Zentiva (previously Irbesartan Winthrop);Imprida;Exforge;Copalia HCT;Copalia;Dafiro HCT;Dafiro", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2013" }, { "title": "European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Biosimilars;Medicines", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-first-two-monoclonal-antibody-biosimilars" }, { "title": "European Medicines Agency recommends approval of Tafinlar for the treatment of metastatic melanoma", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-tafinlar-treatment-metastatic-melanoma" }, { "title": "European Medicines Agency recommends approval of fourth advanced therapy in Europe", "press_release": "Yes", "related_medicine_referral": "Provenge", "categories": "Human", "topics": "Advanced therapies;Medicines", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-fourth-advanced-therapy-europe" }, { "title": "European Medicines Agency IT systems unavailable Saturday 29 June", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-it-systems-unavailable-saturday-29-june" }, { "title": "New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/new-recommendations-manage-risk-allergic-reactions-intravenous-iron-containing-medicines" }, { "title": "Restrictions in the use of flupirtine-containing medicines - CMDh endorses PRAC recommendation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/restrictions-use-flupirtine-containing-medicines-cmdh-endorses-prac-recommendation" }, { "title": "New restrictions on use of medicines containing ergot derivatives", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/new-restrictions-use-medicines-containing-ergot-derivatives" }, { "title": "Restrictions on use of codeine for pain relief in children – CMDh endorses PRAC recommendation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Pharmacovigilance", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/restrictions-use-codeine-pain-relief-children-cmdh-endorses-prac-recommendation" }, { "title": "New safety advice for diclofenac – CMDh endorses PRAC recommendation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "28/06/2013", "last_updated_date": "28/06/2013", "news_url": "https://www.ema.europa.eu/en/news/new-safety-advice-diclofenac-cmdh-endorses-prac-recommendation" }, { "title": "European Medicines Agency releases for public consultation its draft policy on the publication and access to clinical-trial data", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "24/06/2013", "last_updated_date": "24/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-public-consultation-its-draft-policy-publication-access-clinical-trial-data" }, { "title": "European Commission report highlights successes of the first five years of the EU Paediatric Regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "24/06/2013", "last_updated_date": "24/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-commission-report-highlights-successes-first-five-years-eu-paediatric-regulation" }, { "title": "Guidance on submission of single assessment PSURs published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "24/06/2013", "last_updated_date": "24/06/2013", "news_url": "https://www.ema.europa.eu/en/news/guidance-submission-single-assessment-psurs-published" }, { "title": "Registration open for workshop on the clinical investigation of medicines for the treatment of multiple sclerosis", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/06/2013", "last_updated_date": "20/06/2013", "news_url": "https://www.ema.europa.eu/en/news/registration-open-workshop-clinical-investigation-medicines-treatment-multiple-sclerosis" }, { "title": "Committee for Medicinal Products for Veterinary Use re-elects Dr Anja Holm as chair", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/06/2013", "last_updated_date": "19/06/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-re-elects-dr-anja-holm-chair" }, { "title": "European Medicines Agency revises MUMS / limited-market policy", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines;Veterinary limited markets", "news_summary": "", "first_published_date": "18/06/2013", "last_updated_date": "18/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-revises-mums-limited-market-policy" }, { "title": "European Medicines Agency's Management Board endorses revised EMA code of conduct", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/06/2013", "last_updated_date": "17/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-endorses-revised-ema-code-conduct" }, { "title": "Registration opens for workshop on EMA-HTA parallel scientific advice in drug development", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/06/2013", "last_updated_date": "14/06/2013", "news_url": "https://www.ema.europa.eu/en/news/registration-opens-workshop-ema-hta-parallel-scientific-advice-drug-development" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 June 2013", "press_release": "Yes", "related_medicine_referral": "Econor;Locatim (previously Serinucoli);Certifect;Zulvac 8 Ovis;Zulvac 8 Bovis;Zactran;Suvaxyn PCV;Suprelorin;Rheumocam;Nobilis OR Inac;Melovem;Melosus;Equilis Te;Equilis Prequenza Te;Equilis Prequenza;Emdocam;Comfortis;Cardalis;Activyl Tick Plus;Trocoxil;MS-H Vaccine", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/06/2013", "last_updated_date": "14/06/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-june-2013" }, { "title": "PRAC recommends restricting the use of flupirtine-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "14/06/2013", "last_updated_date": "14/06/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-restricting-use-flupirtine-containing-medicines" }, { "title": "PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl starch", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "14/06/2013", "last_updated_date": "14/06/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-suspending-marketing-authorisations-infusion-solutions-containing-hydroxyethyl-starch" }, { "title": "PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "14/06/2013", "last_updated_date": "14/06/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-same-cardiovascular-precautions-diclofenac-selective-cox-2-inhibitors" }, { "title": "PRAC recommends restricting the use of codeine when used for pain relief in children", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "14/06/2013", "last_updated_date": "14/06/2013", "news_url": "https://www.ema.europa.eu/en/news/prac-recommends-restricting-use-codeine-when-used-pain-relief-children" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "14/06/2013", "last_updated_date": "14/06/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-june-2013" }, { "title": "Revised guideline on biosimilars containing biotechnology-derived proteins published for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Biosimilars;Regulatory and procedural guidance", "news_summary": "", "first_published_date": "10/06/2013", "last_updated_date": "10/06/2013", "news_url": "https://www.ema.europa.eu/en/news/revised-guideline-biosimilars-containing-biotechnology-derived-proteins-published-public-consultation" }, { "title": "European Medicines Agency publishes interim fee advice for bluetongue-vaccine manufacturers", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/06/2013", "last_updated_date": "07/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-interim-fee-advice-bluetongue-vaccine-manufacturers" }, { "title": "Public consultation open on guideline on the acceptability of names for human medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "07/06/2013", "last_updated_date": "07/06/2013", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-open-guideline-acceptability-names-human-medicines" }, { "title": "Comments invited on good-pharmacovigilance-practice module on reporting of adverse reactions", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/06/2013", "last_updated_date": "07/06/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-good-pharmacovigilance-practice-module-reporting-adverse-reactions" }, { "title": "European Medicines Agency and EUnetHTA review progress of their cooperation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/06/2013", "last_updated_date": "07/06/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-eunethta-review-progress-their-cooperation" }, { "title": "Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/06/2013", "last_updated_date": "05/06/2013", "news_url": "https://www.ema.europa.eu/en/news/amendments-pharmacovigilance-legislation-new-notification-requirements-marketing-authorisation-holders" }, { "title": "Revised version of application form for initial evaluation of human medicines available", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/06/2013", "last_updated_date": "03/06/2013", "news_url": "https://www.ema.europa.eu/en/news/revised-version-application-form-initial-evaluation-human-medicines-available" }, { "title": "European Medicines Agency recommends approval of pomalidomide for the treatment of multiple myeloma", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "31/05/2013", "last_updated_date": "31/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-pomalidomide-treatment-multiple-myeloma" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2013", "press_release": "No", "related_medicine_referral": "Glivec;Tysabri;Trobalt;Prevenar 13;Lucentis;Lantus;Lysodren;Toujeo (previously Optisulin)", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "31/05/2013", "last_updated_date": "31/05/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-may-2013" }, { "title": "Oral almitrine to be withdrawn by EU Member States", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "31/05/2013", "last_updated_date": "31/05/2013", "news_url": "https://www.ema.europa.eu/en/news/oral-almitrine-be-withdrawn-eu-member-states" }, { "title": "European Medicines Agency recommends restricting Trobalt to last-line therapy in partial epilepsy", "press_release": "Yes", "related_medicine_referral": "Trobalt", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "31/05/2013", "last_updated_date": "31/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-trobalt-last-line-therapy-partial-epilepsy" }, { "title": "Guideline on the clinical development of medicines for the treatment of pain released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "30/05/2013", "last_updated_date": "30/05/2013", "news_url": "https://www.ema.europa.eu/en/news/guideline-clinical-development-medicines-treatment-pain-released-public-consultation" }, { "title": "European Medicines Agency publishes guideline on clinical investigation of medicines for depression", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "30/05/2013", "last_updated_date": "30/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-guideline-clinical-investigation-medicines-depression" }, { "title": "Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC recommendation endorsed by CMDh", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "30/05/2013", "last_updated_date": "30/05/2013", "news_url": "https://www.ema.europa.eu/en/news/benefits-diane-35-its-generics-outweigh-risks-certain-patient-groups-prac-recommendation-endorsed-cmdh" }, { "title": "Comments invited on guideline for the demonstration of efficacy for veterinary medicines containing antimicrobials", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "29/05/2013", "last_updated_date": "29/05/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-guideline-demonstration-efficacy-veterinary-medicines-containing-antimicrobials" }, { "title": "European Medicines Agency issues six key recommendations to tackle the issue of medication errors", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "23/05/2013", "last_updated_date": "23/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-issues-six-key-recommendations-tackle-issue-medication-errors" }, { "title": "eSubmission Gateway or web client to become mandatory for all eCTD submissions through the centralised procedure in 2014", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/05/2013", "last_updated_date": "22/05/2013", "news_url": "https://www.ema.europa.eu/en/news/esubmission-gateway-or-web-client-become-mandatory-all-ectd-submissions-through-centralised-procedure-2014" }, { "title": "European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "17/05/2013", "last_updated_date": "17/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reiterates-prac-recommendation-diane-35-generics" }, { "title": "International Clinical Trials Day: 20 May 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/05/2013", "last_updated_date": "17/05/2013", "news_url": "https://www.ema.europa.eu/en/news/international-clinical-trials-day-20-may-2013" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2013", "press_release": "Yes", "related_medicine_referral": "ProZinc;Aftovaxpur DOE;Zulvac 1+8 Ovis;BTVPUR;BTVPUR AlSap 1;Panacur AquaSol;Poulvac E. coli;TruScient;SevoFlo;Virbagen Omega;Oxyglobin;Locatim (previously Serinucoli);Posatex;Onsior;Hiprabovis IBR Marker Live;Suvaxyn PCV;BTVPUR AlSap 2-4;Acticam;Zactran;Reconcile;Respiporc Flu3;Gripovac 3;Activyl;Circovac", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/05/2013", "last_updated_date": "17/05/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-may-2013" }, { "title": "European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "17/05/2013", "last_updated_date": "17/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-first-vaccine-foot-mouth-disease-authorisation-eu-level" }, { "title": "Benefits of Diane 35 and generics outweigh risks in specific patient group", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "17/05/2013", "last_updated_date": "17/05/2013", "news_url": "https://www.ema.europa.eu/en/news/benefits-diane-35-generics-outweigh-risks-specific-patient-group" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013", "press_release": "No", "related_medicine_referral": "Protelos;Osseor;Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop);Karvezide;Irbesartan/Hydrochlorothiazide Teva;Exforge HCT;Dafiro HCT;Copalia HCT;Imprida;Exforge;Dafiro;Copalia;PritorPlus;MicardisPlus;Kinzalkomb;Actelsar HCT;Twynsta;Onduarp;Tolura;Telmisartan Teva Pharma;Telmisartan Teva;Telmisartan Actavis;Pritor;Micardis;Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG);Karvezide;Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop);Irbesartan/Hydrochlorothiazide Teva;Ifirmacombi;CoAprovel;Sabervel;Karvea;Irbesartan Zentiva (previously Irbesartan Winthrop);Irbesartan Teva;Ifirmasta (previously Irbesartan Krka);Aprovel;Ipreziv;Edarbi;Rasitrio;Rasilez HCT;Rasilez;Rasilamlo", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "17/05/2013", "last_updated_date": "17/05/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-may-2013" }, { "title": "European Medicines Agency closed 20 May 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/05/2013", "last_updated_date": "16/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-20-may-2013" }, { "title": "World Hypertension Day: 17 May 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/05/2013", "last_updated_date": "16/05/2013", "news_url": "https://www.ema.europa.eu/en/news/world-hypertension-day-17-may-2013" }, { "title": "European Medicines Agency simplifies processing of fee reductions for orphan medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "08/05/2013", "last_updated_date": "08/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-simplifies-processing-fee-reductions-orphan-medicines" }, { "title": "Comments invited on draft revised guideline on biosimilars", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Biosimilars;Regulatory and procedural guidance", "news_summary": "", "first_published_date": "08/05/2013", "last_updated_date": "08/05/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-draft-revised-guideline-biosimilars" }, { "title": "New recommendations on the use of phthalates and parabens as excipients in human medicines released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/05/2013", "last_updated_date": "08/05/2013", "news_url": "https://www.ema.europa.eu/en/news/new-recommendations-use-phthalates-parabens-excipients-human-medicines-released-public-consultation" }, { "title": "European Medicines Agency closed 9-10 May 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/05/2013", "last_updated_date": "07/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-9-10-may-2013" }, { "title": "European Medicines Agency website unavailable Saturday 4 May", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-saturday-4-may" }, { "title": "European Medicines Agency reorganisation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "03/05/2013", "last_updated_date": "03/05/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reorganisation" }, { "title": "European Medicines Agency publishes final advice from clinical-trial advisory groups", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "30/04/2013", "last_updated_date": "30/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-final-advice-clinical-trial-advisory-groups" }, { "title": "European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "30/04/2013", "last_updated_date": "30/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-receives-interim-decisions-general-court-eu-access-clinical-non-clinical-information" }, { "title": "European Medicines Agency closed 1 May 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/04/2013", "last_updated_date": "29/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-may-2013" }, { "title": "Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/04/2013", "last_updated_date": "29/04/2013", "news_url": "https://www.ema.europa.eu/en/news/recommendation-suspend-tetrazepam-containing-medicines-endorsed-cmdh" }, { "title": "World Veterinary Day on 27 April 2013: 'Vaccination to prevent and protect'", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Corporate", "topics": "", "news_summary": "", "first_published_date": "26/04/2013", "last_updated_date": "26/04/2013", "news_url": "https://www.ema.europa.eu/en/news/world-veterinary-day-27-april-2013-vaccination-prevent-protect" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013", "press_release": "No", "related_medicine_referral": "Revlimid;RoActemra;Xeljanz;Osseor;Protelos;Twynsta;Onduarp;Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG);Kinzalkomb;PritorPlus;MicardisPlus;Pritor;Micardis;Menveo;Increlex;Caelyx pegylated liposomal;Exjade;Pradaxa", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/04/2013", "last_updated_date": "26/04/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2013" }, { "title": "European Medicines Agency recommends approval of first treatment for pseudobulbar affect", "press_release": "Yes", "related_medicine_referral": "Nuedexta", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/04/2013", "last_updated_date": "26/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-first-treatment-pseudobulbar-affect" }, { "title": "European Medicines Agency recommends approval of combined advanced-therapy product", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies;Medicines", "news_summary": "", "first_published_date": "26/04/2013", "last_updated_date": "26/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-combined-advanced-therapy-product" }, { "title": "Recommendation to restrict the use of Protelos / Osseor (strontium ranelate)", "press_release": "Yes", "related_medicine_referral": "Protelos;Osseor", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/04/2013", "last_updated_date": "26/04/2013", "news_url": "https://www.ema.europa.eu/en/news/recommendation-restrict-use-protelos-osseor-strontium-ranelate" }, { "title": "European Medicines Agency publishes initial list of medicines under additional monitoring", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "25/04/2013", "last_updated_date": "25/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-initial-list-medicines-under-additional-monitoring" }, { "title": "Stem-cell-therapy treatments", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "22/04/2013", "last_updated_date": "22/04/2013", "news_url": "https://www.ema.europa.eu/en/news/stem-cell-therapy-treatments" }, { "title": "Key deliverable of Falsified Medicines Directive achieved", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "18/04/2013", "last_updated_date": "18/04/2013", "news_url": "https://www.ema.europa.eu/en/news/key-deliverable-falsified-medicines-directive-achieved" }, { "title": "European Medicines Agency publishes 2012 annual report", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/04/2013", "last_updated_date": "16/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-2012-annual-report" }, { "title": "Use of antibiotics in animals - European Medicines Agency to give advice to European Commission on public- and animal-health impact", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/04/2013", "last_updated_date": "16/04/2013", "news_url": "https://www.ema.europa.eu/en/news/use-antibiotics-animals-european-medicines-agency-give-advice-european-commission-public-animal-health-impact" }, { "title": "ENCePP e-register reaches 100 post-authorisation studies", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/04/2013", "last_updated_date": "15/04/2013", "news_url": "https://www.ema.europa.eu/en/news/encepp-e-register-reaches-100-post-authorisation-studies" }, { "title": "Committee for Medicinal Products for Veterinary Use holds 200th meeting", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/04/2013", "last_updated_date": "15/04/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-holds-200th-meeting" }, { "title": "EU agencies consider phenylbutazone detected in horsemeat of low concern for consumers; recommend improved horse traceability and monitoring of veterinary medicinal residues", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/04/2013", "last_updated_date": "15/04/2013", "news_url": "https://www.ema.europa.eu/en/news/eu-agencies-consider-phenylbutazone-detected-horsemeat-low-concern-consumers-recommend-improved-horse-traceability-monitoring-veterinary-medicinal-residues" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 April 2013", "press_release": "Yes", "related_medicine_referral": "Equilis West Nile;Contacera;Porcilis AR-T DF;Inflacam;Porcilis ColiClos;Zuprevo;Palladia;MS-H Vaccine;Meloxoral;Masivet;Improvac;Aivlosin;Equip WNV (previously Duvaxyn WNV);Activyl;Equioxx;Zulvac 8 Bovis;Zulvac 8 Ovis;Cardalis", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/04/2013", "last_updated_date": "12/04/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-april-2013" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2013", "press_release": "No", "related_medicine_referral": "Protelos;Osseor", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "12/04/2013", "last_updated_date": "12/04/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2013" }, { "title": "European Medicines Agency publishes report on patient recruitment and geographical location of clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "09/04/2013", "last_updated_date": "09/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-report-patient-recruitment-geographical-location-clinical-trials" }, { "title": "World Health Day on 7 April 2013: focus on high blood pressure", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/04/2013", "last_updated_date": "05/04/2013", "news_url": "https://www.ema.europa.eu/en/news/world-health-day-7-april-2013-focus-high-blood-pressure" }, { "title": "European Medicines Agency welcomes new Head of Infrastructure Services", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "02/04/2013", "last_updated_date": "02/04/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-infrastructure-services" }, { "title": "European Medicines Agency to begin PSUR assessment based on active substances in both centrally and nationally authorised medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "27/03/2013", "last_updated_date": "27/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-begin-psur-assessment-based-active-substances-both-centrally-nationally-authorised-medicines" }, { "title": "Increased fees coming into effect on 1 April 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/03/2013", "last_updated_date": "27/03/2013", "news_url": "https://www.ema.europa.eu/en/news/increased-fees-coming-effect-1-april-2013" }, { "title": "European Medicines Agency updates procedural guidance in line with new pharmacovigilance legislation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/03/2013", "last_updated_date": "26/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-procedural-guidance-line-new-pharmacovigilance-legislation" }, { "title": "European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes", "press_release": "Yes", "related_medicine_referral": "Byetta;Januvia;Lyxumia;Jentadueto;Trajenta;Komboglyze;Bydureon;Ristfor;Ristaben;Xiliarx;Icandra (previously Vildagliptin / metformin hydrochloride Novartis);Zomarist;Jalra;Efficib;Onglyza;Victoza;Tesavel;Velmetia;Janumet;Eucreas;Galvus;Xelevia", "categories": "Corporate", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "26/03/2013", "last_updated_date": "26/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-investigates-findings-pancreatic-risks-glp-1-based-therapies-type-2-diabetes" }, { "title": "European Medicines Agency closed 28 March - 1 April 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/03/2013", "last_updated_date": "26/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-28-march-1-april-2013" }, { "title": "European Medicines Agency's Management Board welcomes new civil-society members", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "25/03/2013", "last_updated_date": "25/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-welcomes-new-civil-society-members" }, { "title": "European Medicines Agency issues recommendations for 2013/2014 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/03/2013", "last_updated_date": "22/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-issues-recommendations-2013-2014-seasonal-flu-vaccine-composition" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013", "press_release": "No", "related_medicine_referral": "MabThera;Viread;Xarelto;Soliris", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/03/2013", "last_updated_date": "22/03/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-march-2013" }, { "title": "European Medicines Agency recommends restricting use of cilostazol-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/03/2013", "last_updated_date": "22/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines" }, { "title": "CellSeed Europe Ltd. withdraws its marketing-authorisation application for OraNera (autologous oral mucosal epithelial cells)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/03/2013", "last_updated_date": "20/03/2013", "news_url": "https://www.ema.europa.eu/en/news/cellseed-europe-ltd-withdraws-its-marketing-authorisation-application-oranera-autologous-oral-mucosal-epithelial-cells" }, { "title": "European Medicines Agency reminds companies of timeframe to submit product-information translations in Croatian", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/03/2013", "last_updated_date": "19/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reminds-companies-timeframe-submit-product-information-translations-croatian" }, { "title": "European Medicines Agency updates product-information template to label medicines subject to additional monitoring and encourage adverse-reaction reporting", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "15/03/2013", "last_updated_date": "15/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-product-information-template-label-medicines-subject-additional-monitoring-encourage-adverse-reaction-reporting" }, { "title": "European Medicines Agency and European Commission renew confidentiality arrangement with Canada", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "15/03/2013", "last_updated_date": "15/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-commission-renew-confidentiality-arrangement-canada" }, { "title": "Simplification of submission of applications for centrally authorised medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/03/2013", "last_updated_date": "15/03/2013", "news_url": "https://www.ema.europa.eu/en/news/simplification-submission-applications-centrally-authorised-medicines" }, { "title": "Vanda Pharmaceuticals Ltd withdraws its marketing-authorisation application for Fanaptum (iloperidone)", "press_release": "Yes", "related_medicine_referral": "Fanaptum", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/03/2013", "last_updated_date": "14/03/2013", "news_url": "https://www.ema.europa.eu/en/news/vanda-pharmaceuticals-ltd-withdraws-its-marketing-authorisation-application-fanaptum-iloperidone" }, { "title": "14 March 2013: World Kidney Day: 'Acute kidney injury: stop kidney attack!'", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/03/2013", "last_updated_date": "13/03/2013", "news_url": "https://www.ema.europa.eu/en/news/14-march-2013-world-kidney-day-acute-kidney-injury-stop-kidney-attack" }, { "title": "European Medicines Agency focuses on new legislation, increased efficiency and transparency in 2013 work programme", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "13/03/2013", "last_updated_date": "13/03/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-focuses-new-legislation-increased-efficiency-transparency-2013-work-programme" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 March 2013", "press_release": "Yes", "related_medicine_referral": "Procox;Posatex;Veraflox;Suvaxyn PCV;Porcilis PCV;CaniLeish", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/03/2013", "last_updated_date": "08/03/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-march-2013" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2013", "press_release": "No", "related_medicine_referral": "Kogenate Bayer;Helixate NexGen", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "08/03/2013", "last_updated_date": "08/03/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-march-2013" }, { "title": "EU agencies to advise on risks from phenylbutazone in horsemeat", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/03/2013", "last_updated_date": "07/03/2013", "news_url": "https://www.ema.europa.eu/en/news/eu-agencies-advise-risks-phenylbutazone-horsemeat" }, { "title": "Public consultation starts on first guideline on medicines for the treatment of lupus erythematous", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "05/03/2013", "last_updated_date": "05/03/2013", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-starts-first-guideline-medicines-treatment-lupus-erythematous" }, { "title": "Tackling medication errors: European Medicines Agency workshop calls for coordinated EU approach", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/03/2013", "last_updated_date": "01/03/2013", "news_url": "https://www.ema.europa.eu/en/news/tackling-medication-errors-european-medicines-agency-workshop-calls-coordinated-eu-approach" }, { "title": "28 February 2013 - Rare Disease Day: 'Rare disorders without borders'", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/02/2013", "last_updated_date": "27/02/2013", "news_url": "https://www.ema.europa.eu/en/news/28-february-2013-rare-disease-day-rare-disorders-without-borders" }, { "title": "Anika Therapeutics S.r.l. withdraws its marketing-authorisation application for Hyalograft C autograft", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/02/2013", "last_updated_date": "27/02/2013", "news_url": "https://www.ema.europa.eu/en/news/anika-therapeutics-srl-withdraws-its-marketing-authorisation-application-hyalograft-c-autograft" }, { "title": "European Medicines Agency revises three guidance documents to include orphan-related information", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/02/2013", "last_updated_date": "26/02/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-revises-three-guidance-documents-include-orphan-related-information" }, { "title": "Adjusted fees for applications to European Medicines Agency from 1 April 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "25/02/2013", "last_updated_date": "25/02/2013", "news_url": "https://www.ema.europa.eu/en/news/adjusted-fees-applications-european-medicines-agency-1-april-2013" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013", "press_release": "No", "related_medicine_referral": "Cervarix;Privigen", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/02/2013", "last_updated_date": "22/02/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-february-2013" }, { "title": "Public consultation opens on standard paediatric investigation plans for two types of cancer in children", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "22/02/2013", "last_updated_date": "22/02/2013", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-opens-standard-paediatric-investigation-plans-two-types-cancer-children" }, { "title": "SME office: outcomes of seven years of active support to small and medium-size businesses", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "20/02/2013", "last_updated_date": "20/02/2013", "news_url": "https://www.ema.europa.eu/en/news/sme-office-outcomes-seven-years-active-support-small-medium-size-businesses" }, { "title": "Committee for paediatric medicinal products - towards more and better information on the use of medicines for children", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "18/02/2013", "last_updated_date": "18/02/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-paediatric-medicinal-products-towards-more-better-information-use-medicines-children" }, { "title": "Committee for Veterinary Medicinal Products - focus on reducing the risk of antimicrobial resistance and strengthening quality assurance", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/02/2013", "last_updated_date": "15/02/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-focus-reducing-risk-antimicrobial-resistance-strengthening-quality-assurance" }, { "title": "Committee for Orphan Medicinal Products – strengthened interactions with patients and international partners", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "14/02/2013", "last_updated_date": "14/02/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-strengthened-interactions-patients-international-partners" }, { "title": "Committee for Advanced Therapies – focus on incentives for SMEs and strengthened interaction with stakeholders", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;SME;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "13/02/2013", "last_updated_date": "13/02/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-focus-incentives-smes-strengthened-interaction-stakeholders" }, { "title": "Herbal medicines – strengthening assessment methodology and improved communication for the public", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal;Herbal", "topics": "", "news_summary": "", "first_published_date": "12/02/2013", "last_updated_date": "12/02/2013", "news_url": "https://www.ema.europa.eu/en/news/herbal-medicines-strengthening-assessment-methodology-improved-communication-public" }, { "title": "The PROTECT project on pharmacovigilance achieves key objectives", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/02/2013", "last_updated_date": "12/02/2013", "news_url": "https://www.ema.europa.eu/en/news/protect-project-pharmacovigilance-achieves-key-objectives" }, { "title": "Pharmacovigilance Risk Assessment Committee (PRAC) invites stakeholders' feedback in review of Diane 35 and its generics", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "12/02/2013", "last_updated_date": "12/02/2013", "news_url": "https://www.ema.europa.eu/en/news/pharmacovigilance-risk-assessment-committee-prac-invites-stakeholders-feedback-review-diane-35-its-generics" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 February 2013", "press_release": "Yes", "related_medicine_referral": "Equilis Prequenza;Equilis Prequenza Te;Suprelorin;Zulvac 1+8 Ovis;Zulvac 1+8 Bovis;Rhiniseng;Purevax Rabies;Profender;Nobivac Myxo-RHD;Netvax;Coxevac;Bovilis BTV8;Bluevac BTV (previously Bluevac BTV8);BTVPUR;BTVPUR AlSap 1", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/02/2013", "last_updated_date": "08/02/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-february-2013" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 February 2013", "press_release": "No", "related_medicine_referral": "Evra;Ioa;Zoely", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "08/02/2013", "last_updated_date": "08/02/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-february-2013" }, { "title": "European Medicines Agency starts safety review of Diane 35 and its generics", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "08/02/2013", "last_updated_date": "08/02/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-safety-review-diane-35-its-generics" }, { "title": "European Medicines Agency and European Commission renew confidentiality arrangement with Japan", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/02/2013", "last_updated_date": "07/02/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-commission-renew-confidentiality-arrangement-japan" }, { "title": "World Cancer Day: 4 February 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/02/2013", "last_updated_date": "01/02/2013", "news_url": "https://www.ema.europa.eu/en/news/world-cancer-day-4-february-2013" }, { "title": "Comments invited on joint EU-Japan reflection paper on medicines delivered using nano-sized block copolymer micelles", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/02/2013", "last_updated_date": "01/02/2013", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-joint-eu-japan-reflection-paper-medicines-delivered-using-nano-sized-block-copolymer-micelles" }, { "title": "Public consultation opens on draft guideline on biosimilars containing low-molecular-weight heparins", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Biosimilars;Regulatory and procedural guidance", "news_summary": "", "first_published_date": "31/01/2013", "last_updated_date": "31/01/2013", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-opens-draft-guideline-biosimilars-containing-low-molecular-weight-heparins" }, { "title": "European Medicines Agency update on Diane 35 and generics used in the treatment of acne", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "30/01/2013", "last_updated_date": "30/01/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-diane-35-generics-used-treatment-acne" }, { "title": "First meeting of the Modelling and Simulation Working Group", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/01/2013", "last_updated_date": "30/01/2013", "news_url": "https://www.ema.europa.eu/en/news/first-meeting-modelling-simulation-working-group" }, { "title": "European Medicines Agency seeking participants for website user-testing research", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/01/2013", "last_updated_date": "29/01/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-seeking-participants-website-user-testing-research" }, { "title": "European Medicines Agency to review third- and fourth-generation combined oral contraceptives", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "28/01/2013", "last_updated_date": "28/01/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-review-third-fourth-generation-combined-oral-contraceptives" }, { "title": "Novartis Europharm Ltd withdraws its marketing-authorisation application for Ruvise (imatinib mesilate)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/01/2013", "last_updated_date": "24/01/2013", "news_url": "https://www.ema.europa.eu/en/news/novartis-europharm-ltd-withdraws-its-marketing-authorisation-application-ruvise-imatinib-mesilate" }, { "title": "Updated formatted table template for dossier submission available", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/01/2013", "last_updated_date": "24/01/2013", "news_url": "https://www.ema.europa.eu/en/news/updated-formatted-table-template-dossier-submission-available" }, { "title": "European Medicines Agency publishes guidance on preparing and reviewing summaries of product characteristics", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "21/01/2013", "last_updated_date": "21/01/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-guidance-preparing-reviewing-summaries-product-characteristics" }, { "title": "Framework for a close collaboration with Israel in place", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/01/2013", "last_updated_date": "21/01/2013", "news_url": "https://www.ema.europa.eu/en/news/framework-close-collaboration-israel-place" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013", "press_release": "No", "related_medicine_referral": "Humira;Pegasys;Ilaris;Trevaclyn;Pelzont;Tredaptive;Komboglyze;Onglyza", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "18/01/2013", "last_updated_date": "18/01/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-january-2013" }, { "title": "European Medicines Agency recommends approval of medicine for treatment of vitreomacular traction", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "18/01/2013", "last_updated_date": "18/01/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-medicine-treatment-vitreomacular-traction" }, { "title": "European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn", "press_release": "Yes", "related_medicine_referral": "Tredaptive;Pelzont;Trevaclyn", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/01/2013", "last_updated_date": "18/01/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-recommendation-suspend-tredaptive-pelzont-trevaclyn" }, { "title": "eSubmission Gateway release II and eSubmission web client now live for all applications for human medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/01/2013", "last_updated_date": "15/01/2013", "news_url": "https://www.ema.europa.eu/en/news/esubmission-gateway-release-ii-esubmission-web-client-now-live-all-applications-human-medicines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 January 2013", "press_release": "Yes", "related_medicine_referral": "Inflacam;Rheumocam;Zuprevo;Zulvac 1 Bovis;Startvac;RevitaCAM;Reconcile;Proteq West Nile;Ingelvac CircoFLEX;Gripovac 3;Emdocam;Cimalgex;ProteqFlu-Te;ProteqFlu;Loxicom", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/01/2013", "last_updated_date": "11/01/2013", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-january-2013" }, { "title": "FGK Representative Service GmbH withdraws its marketing-authorisation application for Memantine FGK (memantine)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/01/2013", "last_updated_date": "11/01/2013", "news_url": "https://www.ema.europa.eu/en/news/fgk-representative-service-gmbh-withdraws-its-marketing-authorisation-application-memantine-fgk-memantine" }, { "title": "European Medicines Agency updates guideline on evaluation of anticancer medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "11/01/2013", "last_updated_date": "11/01/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-guideline-evaluation-anticancer-medicines" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 January 2013", "press_release": "No", "related_medicine_referral": "Tredaptive;Pelzont;Trevaclyn", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "11/01/2013", "last_updated_date": "11/01/2013", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-january-2013" }, { "title": "European Medicines Agency update on combined contraceptives", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "11/01/2013", "last_updated_date": "11/01/2013", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-combined-contraceptives" }, { "title": "European Medicines Agency starts review of Tredaptive, Pelzont and Trevaclyn", "press_release": "Yes", "related_medicine_referral": "Pelzont;Tredaptive;Trevaclyn", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "21/12/2012", "last_updated_date": "21/12/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-review-tredaptive-pelzont-trevaclyn" }, { "title": "European Medicines Agency closed 24 December 2012 to 2 January 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "20/12/2012", "last_updated_date": "20/12/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-24-december-2012-2-january-2013" }, { "title": "Only For Children Pharmaceuticals withdraws its marketing-authorisation application for Loulla (mercaptopurine)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "20/12/2012", "last_updated_date": "20/12/2012", "news_url": "https://www.ema.europa.eu/en/news/only-children-pharmaceuticals-withdraws-its-marketing-authorisation-application-loulla-mercaptopurine" }, { "title": "European Medicines Agency reviews its operations and prepares for reorganisation in 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/12/2012", "last_updated_date": "19/12/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reviews-its-operations-prepares-reorganisation-2013" }, { "title": "European Medicines Agency maintains fee reduction for SMEs developing orphan medicines in 2013", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines;SME", "news_summary": "", "first_published_date": "18/12/2012", "last_updated_date": "18/12/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-maintains-fee-reduction-smes-developing-orphan-medicines-2013" }, { "title": "European Medicines Agency's Management Board endorses work programme 2013", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/12/2012", "last_updated_date": "18/12/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-endorses-work-programme-2013" }, { "title": "eSubmission web client for electronic submissions now available for registration", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "18/12/2012", "last_updated_date": "18/12/2012", "news_url": "https://www.ema.europa.eu/en/news/esubmission-web-client-electronic-submissions-now-available-registration" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 December 2012", "press_release": "Yes", "related_medicine_referral": "Prac-tic;Purevax RC;Certifect;Zulvac 8 Ovis;Zulvac 8 Bovis;Rheumocam;Rheumocam;Respiporc Flu3;Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli);Melosus;Circovac;Zulvac 1+8 Bovis;Zulvac 1 Ovis;Zulvac 1 Bovis;BTVPUR AlSap 2-4;Porcilis PCV;Equioxx;Previcox;Profender;Panacur AquaSol;Purevax RCPCh;Purevax RCP", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/12/2012", "last_updated_date": "14/12/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-december-2012" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012", "press_release": "No", "related_medicine_referral": "Ilaris;Abilify;Jenzyl;Solumarv;Isomarv medium;Combimarv;Zostavax;ProQuad;M-M-RVaxPro;Ixiaro;Pradaxa", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "14/12/2012", "last_updated_date": "14/12/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-december-2012" }, { "title": "European Medicines Agency recommends approval of medicine for reduction of alcohol consumption", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "14/12/2012", "last_updated_date": "14/12/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-medicine-reduction-alcohol-consumption" }, { "title": "European Medicines Agency recommends new advice on safer use of fibrin sealant spray applications", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "14/12/2012", "last_updated_date": "14/12/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-advice-safer-use-fibrin-sealant-spray-applications" }, { "title": "Reminder to applicants regarding requirements for future eCTD submissions", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/12/2012", "last_updated_date": "07/12/2012", "news_url": "https://www.ema.europa.eu/en/news/reminder-applicants-regarding-requirements-future-ectd-submissions" }, { "title": "European Medicines Agency sets out next steps on access to clinical-trial data", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "05/12/2012", "last_updated_date": "05/12/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-sets-out-next-steps-access-clinical-trial-data" }, { "title": "World AIDS Day: 1 December 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/11/2012", "last_updated_date": "30/11/2012", "news_url": "https://www.ema.europa.eu/en/news/world-aids-day-1-december-2012" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 November 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "30/11/2012", "last_updated_date": "30/11/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-november-2012" }, { "title": "Merck Sharp and Dohme Ltd. withdraws its marketing-authorisation application for Jenzyl (ridaforolimus)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "30/11/2012", "last_updated_date": "30/11/2012", "news_url": "https://www.ema.europa.eu/en/news/merck-sharp-dohme-ltd-withdraws-its-marketing-authorisation-application-jenzyl-ridaforolimus" }, { "title": "Marvel LifeSciences Ltd withdraws its marketing-authorisation applications for Solumarv, Isomarv medium and Combimarv (human insulin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/11/2012", "last_updated_date": "27/11/2012", "news_url": "https://www.ema.europa.eu/en/news/marvel-lifesciences-ltd-withdraws-its-marketing-authorisation-applications-solumarv-isomarv-medium-combimarv-human-insulin" }, { "title": "European Medicines Agency provides plan to help deal with manufacturing-related medicine shortages", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/11/2012", "last_updated_date": "26/11/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-provides-plan-help-deal-manufacturing-related-medicine-shortages" }, { "title": "Workshop on access to clinical-trial data and transparency kicks off process towards proactive publication of data", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/11/2012", "last_updated_date": "23/11/2012", "news_url": "https://www.ema.europa.eu/en/news/workshop-access-clinical-trial-data-transparency-kicks-process-towards-proactive-publication-data" }, { "title": "Public consultation open on phasing-in of 'black symbol' for medicines under additional monitoring", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/11/2012", "last_updated_date": "22/11/2012", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-open-phasing-black-symbol-medicines-under-additional-monitoring" }, { "title": "Workshop on clinical-trial data and transparency this afternoon", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/11/2012", "last_updated_date": "22/11/2012", "news_url": "https://www.ema.europa.eu/en/news/workshop-clinical-trial-data-transparency-afternoon" }, { "title": "European Antibiotic Awareness Day: 18 November 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/11/2012", "last_updated_date": "16/11/2012", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-18-november-2012" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012", "press_release": "No", "related_medicine_referral": "Intelence;Exjade;Evicel;Prevenar 13;Zytiga;TachoSil", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "16/11/2012", "last_updated_date": "16/11/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-november-2012" }, { "title": "European Medicines Agency recommends approval of first vaccine for meningitis B", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/11/2012", "last_updated_date": "16/11/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-first-vaccine-meningitis-b" }, { "title": "European Medicines Agency recommends new advice to surgeons on safer use of fibrin sealants Evicel and Quixil", "press_release": "Yes", "related_medicine_referral": "Evicel", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/11/2012", "last_updated_date": "16/11/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-advice-surgeons-safer-use-fibrin-sealants-evicel-quixil" }, { "title": "European Medicines Agency completes review of protamine-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/11/2012", "last_updated_date": "16/11/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-completes-review-protamine-containing-medicines" }, { "title": "World Diabetes Day: 14 November 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/11/2012", "last_updated_date": "13/11/2012", "news_url": "https://www.ema.europa.eu/en/news/world-diabetes-day-14-november-2012" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2012", "press_release": "Yes", "related_medicine_referral": "Equip WNV (previously Duvaxyn WNV);Procox;CaniLeish;Novem;Posatex;Panacur AquaSol;Hiprabovis IBR Marker Live;Equilis StrepE;Comfortis;Cerenia;BTVPUR AlSap 1;Ingelvac CircoFLEX;Advocate;Bluevac BTV (previously Bluevac BTV8);Bovilis BTV8;Zolvix;Naxcel;Onsior;Rheumocam;Inflacam;Advocate;Metacam;Rhiniseng", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/11/2012", "last_updated_date": "09/11/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-november-2012" }, { "title": "European Medicines Agency increases transparency of ongoing applications for human medicines", "press_release": "No", "related_medicine_referral": "Simponi;Onglyza;Komboglyze", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "07/11/2012", "last_updated_date": "07/11/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-increases-transparency-ongoing-applications-human-medicines" }, { "title": "Fee-related incentives for advanced-therapy medicines to expire on 30 December 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "06/11/2012", "last_updated_date": "06/11/2012", "news_url": "https://www.ema.europa.eu/en/news/fee-related-incentives-advanced-therapy-medicines-expire-30-december-2012" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29-31 October 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "31/10/2012", "last_updated_date": "31/10/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-31-october-2012" }, { "title": "Changes to variation rules start to apply from 2 November 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "31/10/2012", "last_updated_date": "31/10/2012", "news_url": "https://www.ema.europa.eu/en/news/changes-variation-rules-start-apply-2-november-2012" }, { "title": "European Medicines Agency closed 1-2 November 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "30/10/2012", "last_updated_date": "30/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-2-november-2012" }, { "title": "European Medicines Agency encourages submission of quality type-I variations by end of November", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/10/2012", "last_updated_date": "29/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-encourages-submission-quality-type-i-variations-end-november" }, { "title": "Update on seasonal-influenza vaccines produced by Novartis Vaccines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Vaccines", "news_summary": "", "first_published_date": "26/10/2012", "last_updated_date": "26/10/2012", "news_url": "https://www.ema.europa.eu/en/news/update-seasonal-influenza-vaccines-produced-novartis-vaccines" }, { "title": "European Medicines Agency's 2010 accounts approved by European Parliament", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "24/10/2012", "last_updated_date": "24/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-2010-accounts-approved-european-parliament" }, { "title": "European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations", "press_release": "Yes", "related_medicine_referral": "Avastin;Bondenza (previously Ibandronic Acid Roche);Zelboraf;Xenical;Xeloda;Viracept;Tarceva;Tamiflu;RoActemra;Pegasys;NeoRecormon;Mircera;MabThera;Invirase;Herceptin;Fuzeon;CellCept;Bonviva;Bondronat", "categories": "Corporate", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "23/10/2012", "last_updated_date": "23/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-infringement-procedure-investigate-roches-alleged-non-compliance-pharmacovigilance-obligations" }, { "title": "European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "19/10/2012", "last_updated_date": "19/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-first-higher-strength-insulin-treatment-patients-diabetes-mellitus-eu" }, { "title": "European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β-amyloid neuritic plaque density", "press_release": "Yes", "related_medicine_referral": "Amyvid", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "19/10/2012", "last_updated_date": "19/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-first-radiopharmaceutical-pet-imaging-b-amyloid-neuritic-plaque-density" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012", "press_release": "No", "related_medicine_referral": "Thyrogen;Humira;Pandemrix;Xarelto;Isentress", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/10/2012", "last_updated_date": "19/10/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-october-2012" }, { "title": "European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "19/10/2012", "last_updated_date": "19/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reviews-hypothesis-pandemrix-development-narcolepsy" }, { "title": "European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "19/10/2012", "last_updated_date": "19/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-review-recent-published-data-cardiovascular-safety-nsaids" }, { "title": "European Medicines Agency publishes report on sales of veterinary antimicrobial agents in 2010", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "15/10/2012", "last_updated_date": "15/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-report-sales-veterinary-antimicrobial-agents-2010" }, { "title": "European SME Week 2012: 15-21 October", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "SME", "news_summary": "", "first_published_date": "15/10/2012", "last_updated_date": "15/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-sme-week-2012-15-21-october" }, { "title": "Public consultation opens on draft guideline on clinical investigation of medicinal products for treatment of acute heart failure", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "15/10/2012", "last_updated_date": "15/10/2012", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-opens-draft-guideline-clinical-investigation-medicinal-products-treatment-acute-heart-failure" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 October 2012", "press_release": "Yes", "related_medicine_referral": "Cortavance;Improvac;Coxevac;Purevax RCP;Porcilis AR-T DF;Palladia;Naxcel;MS-H Vaccine;Meloxivet;Leucogen;Leucofeligen FeLV/RCP;Fevaxyn Pentofel;Easotic;BTVPUR AlSap 2-4;Acticam;Rheumocam;Nobilis Influenza H5N2;Coxevac", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/10/2012", "last_updated_date": "12/10/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-october-2012" }, { "title": "World Arthritis Day: 12 October 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/10/2012", "last_updated_date": "12/10/2012", "news_url": "https://www.ema.europa.eu/en/news/world-arthritis-day-12-october-2012" }, { "title": "European Medicines Agency's conflicts-of-interests handling recognised in European Court of Auditors report", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "11/10/2012", "last_updated_date": "11/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-conflicts-interests-handling-recognised-european-court-auditors-report" }, { "title": "European Medicines Agency on track to meet core business targets for 2012", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "10/10/2012", "last_updated_date": "10/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-track-meet-core-business-targets-2012" }, { "title": "European Medicines Agency releases guideline on medicinal products for the treatment of schizophrenia", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "09/10/2012", "last_updated_date": "09/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-guideline-medicinal-products-treatment-schizophrenia" }, { "title": "World Mental Health Day: 10 October 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/10/2012", "last_updated_date": "09/10/2012", "news_url": "https://www.ema.europa.eu/en/news/world-mental-health-day-10-october-2012" }, { "title": "European Medicines Agency invites feedback on the draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "09/10/2012", "last_updated_date": "09/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-invites-feedback-draft-guideline-clinical-investigation-medicinal-products-treatment-multiple-sclerosis" }, { "title": "European Medicines Agency publishes active substance list with lead Member State responsible for safety monitoring", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "05/10/2012", "last_updated_date": "05/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-active-substance-list-lead-member-state-responsible-safety-monitoring" }, { "title": "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-3 October 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "05/10/2012", "last_updated_date": "05/10/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-3-october-2012" }, { "title": "European Medicines Agency website unavailable intermittently Saturday 6 October", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "04/10/2012", "last_updated_date": "04/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-intermittently-saturday-6-october" }, { "title": "European Commission invites feedback on experience with the Paediatric Regulation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Paediatrics", "news_summary": "", "first_published_date": "03/10/2012", "last_updated_date": "03/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-commission-invites-feedback-experience-paediatric-regulation" }, { "title": "European Medicines Agency publishes list of EU reference dates and frequency of PSUR submission", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/10/2012", "last_updated_date": "01/10/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-list-eu-reference-dates-frequency-psur-submission" }, { "title": "European Medicines Agency reminds marketing-authorisation holders about revised monographs for human normal immunoglobulin", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "28/09/2012", "last_updated_date": "28/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reminds-marketing-authorisation-holders-about-revised-monographs-human-normal-immunoglobulin" }, { "title": "World Heart Day: 29 September 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/09/2012", "last_updated_date": "28/09/2012", "news_url": "https://www.ema.europa.eu/en/news/world-heart-day-29-september-2012" }, { "title": "European Medicines Agency to accept biosimilar reference medicines sourced outside European Economic Area", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Biosimilars;Medicines", "news_summary": "", "first_published_date": "28/09/2012", "last_updated_date": "28/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-accept-biosimilar-reference-medicines-sourced-outside-european-economic-area" }, { "title": "European Medicines Agency seeking participants for website user-experience research", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "28/09/2012", "last_updated_date": "28/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-seeking-participants-website-user-experience-research" }, { "title": "Speakers confirmed for European Medicines Agency workshop on clinical-trial data and transparency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "27/09/2012", "last_updated_date": "27/09/2012", "news_url": "https://www.ema.europa.eu/en/news/speakers-confirmed-european-medicines-agency-workshop-clinical-trial-data-transparency" }, { "title": "Committee for Advanced Therapies' activities streamlined", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Innovation", "news_summary": "", "first_published_date": "24/09/2012", "last_updated_date": "24/09/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-activities-streamlined" }, { "title": "European Medicines Agency recommends first medical treatment for removal of eschar from severe burn wounds", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/09/2012", "last_updated_date": "21/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-first-medical-treatment-removal-eschar-severe-burn-wounds" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2012", "press_release": "No", "related_medicine_referral": "Cialis;Viread;Ibandronic acid Accord;BindRen;Votubia;Eliquis;Trajenta;Komboglyze;Xiliarx;Icandra (previously Vildagliptin / metformin hydrochloride Novartis);Zomarist;Jalra;Multaq;Galvus;Eucreas;Avastin", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "21/09/2012", "last_updated_date": "21/09/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-september-2012" }, { "title": "European Medicines Agency recommends authorisation of first medicine specifically for irritable bowel syndrome", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/09/2012", "last_updated_date": "21/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-first-medicine-specifically-irritable-bowel-syndrome" }, { "title": "European Medicines Agency website unavailable intermittently Saturday 22 September", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "20/09/2012", "last_updated_date": "20/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-intermittently-saturday-22-september" }, { "title": "World Alzheimer's Month: September 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/09/2012", "last_updated_date": "20/09/2012", "news_url": "https://www.ema.europa.eu/en/news/world-alzheimers-month-september-2012" }, { "title": "Merck KGaA withdraws its application for an extension of the indication for Erbitux (cetuximab)", "press_release": "Yes", "related_medicine_referral": "Erbitux", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/09/2012", "last_updated_date": "19/09/2012", "news_url": "https://www.ema.europa.eu/en/news/merck-kgaa-withdraws-its-application-extension-indication-erbitux-cetuximab" }, { "title": "Over 1000 SMEs now registered with European Medicines Agency SME office", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines;SME", "news_summary": "", "first_published_date": "18/09/2012", "last_updated_date": "18/09/2012", "news_url": "https://www.ema.europa.eu/en/news/over-1000-smes-now-registered-european-medicines-agency-sme-office" }, { "title": "Dr Tomas Salmonson elected new chair of the Committee for Medicinal Products for Human Use (CHMP)", "press_release": "No", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "17/09/2012", "last_updated_date": "17/09/2012", "news_url": "https://www.ema.europa.eu/en/news/dr-tomas-salmonson-elected-new-chair-committee-medicinal-products-human-use-chmp" }, { "title": "European Medicines Agency seeks views on involvement of children and young people in Paediatric Committee", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "17/09/2012", "last_updated_date": "17/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-seeks-views-involvement-children-young-people-paediatric-committee" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2012", "press_release": "Yes", "related_medicine_referral": "Inflacam;Rheumocam;Suvaxyn PCV;Procox;Zulvac 1+8 Bovis;Zolvix;Veraflox;Trocoxil;Purevax RCPCh FeLV;Purevax RCPCh;Purevax RCP FeLV;Purevax RC;Purevax Rabies;Nobivac Myxo-RHD;Meloxoral;Emdocam;Comfortis;BTVPUR Alsap 8;Bovilis BTV8;Bluevac BTV (previously Bluevac BTV8);Activyl;Meloxivet;Spironolactone Ceva;Oxyglobin", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/09/2012", "last_updated_date": "14/09/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-september-2012" }, { "title": "RepliGen Europe Limited withdraws its marketing authorisation application for SecreFlo (secretin human)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/09/2012", "last_updated_date": "14/09/2012", "news_url": "https://www.ema.europa.eu/en/news/repligen-europe-limited-withdraws-its-marketing-authorisation-application-secreflo-secretin-human" }, { "title": "Committee for Orphan Medicinal Products elects new chair and vice-chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "13/09/2012", "last_updated_date": "13/09/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-elects-new-chair-vice-chair" }, { "title": "European Medicines Agency website unavailable 19.00 to 23.00 Friday 14 September", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "13/09/2012", "last_updated_date": "13/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-1900-2300-friday-14-september" }, { "title": "European Medicines Agency clarifies rules on fees", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "12/09/2012", "last_updated_date": "12/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-clarifies-rules-fees" }, { "title": "Stella Blackburn appointed president of the International Society for Pharmacoepidemiology", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/09/2012", "last_updated_date": "10/09/2012", "news_url": "https://www.ema.europa.eu/en/news/stella-blackburn-appointed-president-international-society-pharmacoepidemiology" }, { "title": "European Medicines Agency enhances cooperation with EU drug-monitoring agency on psychoactive and abused medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/09/2012", "last_updated_date": "07/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-enhances-cooperation-eu-drug-monitoring-agency-psychoactive-abused-medicines" }, { "title": "Pharmacovigilance Risk Assessment Committee (PRAC) elects chair and vice-chair", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "07/09/2012", "last_updated_date": "07/09/2012", "news_url": "https://www.ema.europa.eu/en/news/pharmacovigilance-risk-assessment-committee-prac-elects-chair-vice-chair" }, { "title": "European Medicines Agency website unavailable 8-9 September", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "06/09/2012", "last_updated_date": "06/09/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-8-9-september" }, { "title": "European Medicines Agency starts consultation on inventory of needs for children's medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "30/08/2012", "last_updated_date": "30/08/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-consultation-inventory-needs-childrens-medicines" }, { "title": "European Medicines Agency gives recommendations to deal with sterility assurance concerns for DepoCyte", "press_release": "Yes", "related_medicine_referral": "DepoCyte", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/08/2012", "last_updated_date": "24/08/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-recommendations-deal-sterility-assurance-concerns-depocyte" }, { "title": "European Medicines Agency closed Monday 27 August", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "23/08/2012", "last_updated_date": "23/08/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-monday-27-august" }, { "title": "European Medicines Agency explains EU incident management plan for human medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "13/08/2012", "last_updated_date": "13/08/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-explains-eu-incident-management-plan-human-medicines" }, { "title": "Proactive publication of clinical-trial data – discussing the way forward", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/08/2012", "last_updated_date": "09/08/2012", "news_url": "https://www.ema.europa.eu/en/news/proactive-publication-clinical-trial-data-discussing-way-forward" }, { "title": "European Medicines Agency publishes public assessment reports for ancillary medicinal substances included in medical devices", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Medical devices", "news_summary": "", "first_published_date": "08/08/2012", "last_updated_date": "08/08/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-public-assessment-reports-ancillary-medicinal-substances-included-medical-devices" }, { "title": "European Medicines Agency phasing out follow-up measures", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "01/08/2012", "last_updated_date": "01/08/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-phasing-out-follow-measures" }, { "title": "European Medicines Agency sees benefits of interaction with Japanese regulators", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "30/07/2012", "last_updated_date": "30/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-sees-benefits-interaction-japanese-regulators" }, { "title": "European Medicines Agency publishes policy on changing scope of paediatric investigation plans", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "27/07/2012", "last_updated_date": "27/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-policy-changing-scope-paediatric-investigation-plans" }, { "title": "World Hepatitis Day: 28 July 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/07/2012", "last_updated_date": "27/07/2012", "news_url": "https://www.ema.europa.eu/en/news/world-hepatitis-day-28-july-2012" }, { "title": "Electronic application forms fully available for use", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/07/2012", "last_updated_date": "27/07/2012", "news_url": "https://www.ema.europa.eu/en/news/electronic-application-forms-fully-available-use" }, { "title": "European Medicines Agency website unavailable 20.00 to 24.00 Friday 27 July", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/07/2012", "last_updated_date": "26/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-2000-2400-friday-27-july" }, { "title": "Two further modules on good pharmacovigilance practices released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/07/2012", "last_updated_date": "26/07/2012", "news_url": "https://www.ema.europa.eu/en/news/two-further-modules-good-pharmacovigilance-practices-released-public-consultation" }, { "title": "European Medicines Agency bids farewell to CHMP Pharmacovigilance Working Party", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "26/07/2012", "last_updated_date": "26/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-bids-farewell-chmp-pharmacovigilance-working-party" }, { "title": "Report available on activities on medicines for children during 2011", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "25/07/2012", "last_updated_date": "25/07/2012", "news_url": "https://www.ema.europa.eu/en/news/report-available-activities-medicines-children-during-2011" }, { "title": "European Medicines Agency publishes sources for orphan-disease prevalence data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "24/07/2012", "last_updated_date": "24/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-sources-orphan-disease-prevalence-data" }, { "title": "Registration open for workshop on access to clinical-trial data and transparency", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/07/2012", "last_updated_date": "20/07/2012", "news_url": "https://www.ema.europa.eu/en/news/registration-open-workshop-access-clinical-trial-data-transparency" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012", "press_release": "No", "related_medicine_referral": "Alli (previously Orlistat GSK);Mircera;PecFent;Torisel;Conbriza;Pradaxa;Ozurdex;Xenical;Prezista;Humira;Xeloda;Tamiflu;Pegasys", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "20/07/2012", "last_updated_date": "20/07/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-july-2012" }, { "title": "European Medicines Agency recommends limiting long-term use of calcitonin medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/07/2012", "last_updated_date": "20/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-limiting-long-term-use-calcitonin-medicines" }, { "title": "European Medicines Agency recommends first gene therapy for approval", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Medicines", "news_summary": "", "first_published_date": "20/07/2012", "last_updated_date": "20/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-first-gene-therapy-approval" }, { "title": "European Medicines Agency publishes video explaining pharmacovigilance legislation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "19/07/2012", "last_updated_date": "19/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-video-explaining-pharmacovigilance-legislation" }, { "title": "European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment Committee (PRAC)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Pharmacovigilance;Pharmacovigilance", "news_summary": "", "first_published_date": "19/07/2012", "last_updated_date": "19/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-holds-first-meeting-pharmacovigilance-risk-assessment-committee-prac" }, { "title": "European Medicines Agency announces plan to publish committee agendas and minutes", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "18/07/2012", "last_updated_date": "18/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-announces-plan-publish-committee-agendas-minutes" }, { "title": "European Medicines Agency launches consultation on pharmacovigilance changes to product information", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/07/2012", "last_updated_date": "16/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-consultation-pharmacovigilance-changes-product-information" }, { "title": "European Medicines Agency appoints Head of International and European Cooperation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/07/2012", "last_updated_date": "16/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-appoints-head-international-european-cooperation" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 July 2012", "press_release": "Yes", "related_medicine_referral": "Onsior;Suvaxyn PCV;Suprelorin;Rhiniseng;Reconcile;Purevax RCCh;Proteq West Nile;Nobilis Influenza H5N2;Zulvac 8 Ovis;Zulvac 8 Bovis;Zulvac 1+8 Ovis;Suvaxyn Aujeszky 783 + O/W;Nobivac Myxo-RHD", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/07/2012", "last_updated_date": "13/07/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-july-2012" }, { "title": "Sanofi-aventis withdraws its marketing authorisation application for Mulsevo (semuloparin sodium)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/07/2012", "last_updated_date": "09/07/2012", "news_url": "https://www.ema.europa.eu/en/news/sanofi-aventis-withdraws-its-marketing-authorisation-application-mulsevo-semuloparin-sodium" }, { "title": "New call for patient and healthcare-professional representatives on European Medicines Agency committees", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "09/07/2012", "last_updated_date": "09/07/2012", "news_url": "https://www.ema.europa.eu/en/news/new-call-patient-healthcare-professional-representatives-european-medicines-agency-committees" }, { "title": "European Medicines Agency updates guideline on drug interactions", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "06/07/2012", "last_updated_date": "06/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-guideline-drug-interactions" }, { "title": "European Medicines Agency finalises update to Parkinson's disease guideline", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "06/07/2012", "last_updated_date": "06/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-update-parkinsons-disease-guideline" }, { "title": "European Medicines Agency encourages companies to use electronic application tools", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "05/07/2012", "last_updated_date": "05/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-encourages-companies-use-electronic-application-tools" }, { "title": "European Medicines Agency urges companies to submit Croatian product information for checking", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "05/07/2012", "last_updated_date": "05/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-urges-companies-submit-croatian-product-information-checking" }, { "title": "European Medicines Agency announces next steps for the maintenance of information on medicines in accordance with mandatory Article 57(2) requirements", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "04/07/2012", "last_updated_date": "04/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-announces-next-steps-maintenance-information-medicines-accordance-mandatory-article-572-requirements" }, { "title": "European Medicines Agency releases new additional guidance for development of antibacterials for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "04/07/2012", "last_updated_date": "04/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-new-additional-guidance-development-antibacterials-public-consultation" }, { "title": "Janssen-Cilag International NV withdraws its application for an extension of the indication for Velcade (bortezomib)", "press_release": "Yes", "related_medicine_referral": "Velcade", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/07/2012", "last_updated_date": "03/07/2012", "news_url": "https://www.ema.europa.eu/en/news/janssen-cilag-international-nv-withdraws-its-application-extension-indication-velcade-bortezomib" }, { "title": "European Medicines Agency finalises update to guideline on renewals", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "02/07/2012", "last_updated_date": "02/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-update-guideline-renewals" }, { "title": "New pharmacovigilance legislation comes into operation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/07/2012", "last_updated_date": "02/07/2012", "news_url": "https://www.ema.europa.eu/en/news/new-pharmacovigilance-legislation-comes-operation" }, { "title": "European Medicines Agency welcomes new Head of Safety and Efficacy of Medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "02/07/2012", "last_updated_date": "02/07/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-safety-efficacy-medicines" }, { "title": "European Medicines Agency reminds companies about arrangements before and during Olympic Games", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "29/06/2012", "last_updated_date": "29/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reminds-companies-about-arrangements-during-olympic-games" }, { "title": "European Medicines Agency finalises update to diabetes guideline", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "29/06/2012", "last_updated_date": "29/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-update-diabetes-guideline" }, { "title": "Two modules of guideline on good pharmacovigilance practices released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "27/06/2012", "last_updated_date": "27/06/2012", "news_url": "https://www.ema.europa.eu/en/news/two-modules-guideline-good-pharmacovigilance-practices-released-public-consultation" }, { "title": "Ferrer Internacional, S.A. withdraws its marketing authorisation application for Egrifta (tesamorelin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/06/2012", "last_updated_date": "26/06/2012", "news_url": "https://www.ema.europa.eu/en/news/ferrer-internacional-sa-withdraws-its-marketing-authorisation-application-egrifta-tesamorelin" }, { "title": "European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "25/06/2012", "last_updated_date": "25/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-first-set-guidelines-good-pharmacovigilance-practices" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 June 2012", "press_release": "No", "related_medicine_referral": "Afinitor;Cayston;Doribax;Humira;Enbrel", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "22/06/2012", "last_updated_date": "22/06/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-june-2012" }, { "title": "European Medicines Agency gives first opinion for a vaccine for use outside the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/06/2012", "last_updated_date": "22/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-first-opinion-vaccine-use-outside-eu" }, { "title": "European Medicines Agency recommends first medical treatment for patients with short bowel syndrome", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/06/2012", "last_updated_date": "22/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-first-medical-treatment-patients-short-bowel-syndrome" }, { "title": "European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax", "press_release": "Yes", "related_medicine_referral": "Doribax", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/06/2012", "last_updated_date": "22/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-advises-doctors-treating-patients-nosocomial-pneumonia-doribax" }, { "title": "European Medicines Agency recommends restricting use of tolperisone medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/06/2012", "last_updated_date": "22/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-tolperisone-medicines" }, { "title": "European Medicines Agency recommends restricting use of trimetazidine-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "22/06/2012", "last_updated_date": "22/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-trimetazidine-containing-medicines" }, { "title": "European Medicines Agency acts on deficiencies in Roche medicines-safety reporting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "21/06/2012", "last_updated_date": "21/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-acts-deficiencies-roche-medicines-safety-reporting" }, { "title": "Celgene Europe Limited withdraws its application for an extension of the indication for Revlimid (lenalidomide)", "press_release": "Yes", "related_medicine_referral": "Revlimid", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/06/2012", "last_updated_date": "21/06/2012", "news_url": "https://www.ema.europa.eu/en/news/celgene-europe-limited-withdraws-its-application-extension-indication-revlimid-lenalidomide" }, { "title": "European Medicines Agency reminds marketing-authorisation holders about requirement for paediatric annual reports", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "21/06/2012", "last_updated_date": "21/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reminds-marketing-authorisation-holders-about-requirement-paediatric-annual-reports" }, { "title": "Concept paper on fees for new pharmacovigilance activities released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/06/2012", "last_updated_date": "20/06/2012", "news_url": "https://www.ema.europa.eu/en/news/concept-paper-fees-new-pharmacovigilance-activities-released-public-consultation" }, { "title": "Committee for Orphan Medicinal Products (COMP) June 2012 highlights", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases;Rare diseases", "news_summary": "", "first_published_date": "18/06/2012", "last_updated_date": "18/06/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-comp-june-2012-highlights" }, { "title": "European Medicines Agency website on suspected side effect reports now in all 23 EU official languages", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "18/06/2012", "last_updated_date": "18/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-suspected-side-effect-reports-now-all-23-eu-official-languages" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 12-14 June 2012", "press_release": "Yes", "related_medicine_referral": "Inflacam;Dexdomitor;Zulvac 8 Bovis;Zactran;Ypozane;Rheumocam;Onsior;Melovem;Melosus;Circovac;Cimalgex;Nobivac Bb;Zulvac 1+8 Ovis;Zulvac 8 Ovis;Zulvac 1 Ovis;Ingelvac CircoFLEX;Respiporc Flu3;Gripovac 3;Fevaxyn Pentofel", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/06/2012", "last_updated_date": "15/06/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-12-14-june-2012" }, { "title": "European Medicines Agency finalises guidance on medicines containing monoclonal antibodies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/06/2012", "last_updated_date": "15/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-guidance-medicines-containing-monoclonal-antibodies" }, { "title": "Management Board completes framework for conflicts of interests", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/06/2012", "last_updated_date": "08/06/2012", "news_url": "https://www.ema.europa.eu/en/news/management-board-completes-framework-conflicts-interests" }, { "title": "European Medicines Agency welcomes 1000th orphan designation", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/06/2012", "last_updated_date": "07/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-1000th-orphan-designation" }, { "title": "European Medicines Agency launches new electronic form for submission of plasma-master-file applications", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/06/2012", "last_updated_date": "07/06/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-new-electronic-form-submission-plasma-master-file-applications" }, { "title": "Annual report 2011 shows continuously high level of activities", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/06/2012", "last_updated_date": "06/06/2012", "news_url": "https://www.ema.europa.eu/en/news/annual-report-2011-shows-continuously-high-level-activities" }, { "title": "Revised guideline on quality of biosimilar medicines open for comments", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Biosimilars;Regulatory and procedural guidance", "news_summary": "", "first_published_date": "31/05/2012", "last_updated_date": "31/05/2012", "news_url": "https://www.ema.europa.eu/en/news/revised-guideline-quality-biosimilar-medicines-open-comments" }, { "title": "European Medicines Agency boosts EU transparency with online publication of suspected side effect reports", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "31/05/2012", "last_updated_date": "31/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-boosts-eu-transparency-online-publication-suspected-side-effect-reports" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012", "press_release": "No", "related_medicine_referral": "Protelos;Osseor;MabThera;Pradaxa;Votrient;Zonegran", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "25/05/2012", "last_updated_date": "25/05/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-may-2012" }, { "title": "European Medicines Agency recommends first-in-class medicine for treatment of cystic fibrosis", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/05/2012", "last_updated_date": "25/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-first-class-medicine-treatment-cystic-fibrosis" }, { "title": "European Medicines Agency confirms positive benefit-risk balance of MabThera", "press_release": "Yes", "related_medicine_referral": "MabThera", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/05/2012", "last_updated_date": "25/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-mabthera" }, { "title": "European Medicines Agency updates patient and prescriber information for Pradaxa", "press_release": "Yes", "related_medicine_referral": "Pradaxa", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "25/05/2012", "last_updated_date": "25/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-patient-prescriber-information-pradaxa" }, { "title": "European Medicines Agency closed 28 May 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "24/05/2012", "last_updated_date": "24/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-28-may-2012" }, { "title": "Practical guidance on implementation of pharmacovigilance legislation published", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/05/2012", "last_updated_date": "23/05/2012", "news_url": "https://www.ema.europa.eu/en/news/practical-guidance-implementation-pharmacovigilance-legislation-published" }, { "title": "Committee for Orphan Medicinal Products (COMP) May 2012 highlights", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases;Rare diseases", "news_summary": "", "first_published_date": "22/05/2012", "last_updated_date": "22/05/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-comp-may-2012-highlights" }, { "title": "European Medicines Agency publishes supplementary information on funding for medicine safety studies through Seventh Framework Programme", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/05/2012", "last_updated_date": "22/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-supplementary-information-funding-medicine-safety-studies-through-seventh-framework-programme" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2012", "press_release": "Yes", "related_medicine_referral": "Vaxxitek HVT+IBD;Improvac;Zuprevo;Porcilis AR-T DF;Slentrol;Posatex;MS-H Vaccine;Leucogen;Leucofeligen FeLV/RCP;Improvac;Hiprabovis IBR Marker Live;Previcox;Equioxx;Equilis Te;Cerenia;BTVPUR Alsap 8;BTVPUR AlSap 2-4;BTVPUR;BTVPUR AlSap 1;Oxyglobin;Nobilis IB 4-91", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "22/05/2012", "last_updated_date": "22/05/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-may-2012" }, { "title": "International Clinical Trials Day: 20 May 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/05/2012", "last_updated_date": "16/05/2012", "news_url": "https://www.ema.europa.eu/en/news/international-clinical-trials-day-20-may-2012" }, { "title": "World Hypertension Day: 17 May 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/05/2012", "last_updated_date": "16/05/2012", "news_url": "https://www.ema.europa.eu/en/news/world-hypertension-day-17-may-2012" }, { "title": "European Medicines Agency launches new e-learning course for Article 57(2) requirements on submission of information on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "16/05/2012", "last_updated_date": "16/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-new-e-learning-course-article-572-requirements-submission-information-medicines" }, { "title": "European Medicines Agency closed 17-18 May 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "15/05/2012", "last_updated_date": "15/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-17-18-may-2012" }, { "title": "European Medicines Agency website upgraded with new features", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "08/05/2012", "last_updated_date": "08/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-upgraded-new-features" }, { "title": "European Medicines Agency closed 9 May 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "07/05/2012", "last_updated_date": "07/05/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-9-may-2012" }, { "title": "Reflection paper on classification of advanced therapies released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Innovation", "news_summary": "", "first_published_date": "30/04/2012", "last_updated_date": "30/04/2012", "news_url": "https://www.ema.europa.eu/en/news/reflection-paper-classification-advanced-therapies-released-public-consultation" }, { "title": "World Veterinary Day: 28 April 2012", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "27/04/2012", "last_updated_date": "27/04/2012", "news_url": "https://www.ema.europa.eu/en/news/world-veterinary-day-28-april-2012" }, { "title": "European Medicines Agency closed 1 May 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/04/2012", "last_updated_date": "27/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-1-may-2012" }, { "title": "European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "27/04/2012", "last_updated_date": "27/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-new-versions-controlled-vocabularies-used-comply-article-57-2-requirements-submission-information-medicines" }, { "title": "European Medicines Agency approves 100th herbal Community monograph", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "Medicines", "news_summary": "", "first_published_date": "27/04/2012", "last_updated_date": "27/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-approves-100th-herbal-community-monograph" }, { "title": "European Medicines Agency's Scientific Coordination Board starts reflection on best cooperation between scientific committees", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "25/04/2012", "last_updated_date": "25/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-scientific-coordination-board-starts-reflection-best-cooperation-between-scientific-committees" }, { "title": "Electronic application form pilot to be extended to initial veterinary applications", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/04/2012", "last_updated_date": "25/04/2012", "news_url": "https://www.ema.europa.eu/en/news/electronic-application-form-pilot-be-extended-initial-veterinary-applications" }, { "title": "eSubmission Gateway now live for all applications for human medicines to the European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/04/2012", "last_updated_date": "23/04/2012", "news_url": "https://www.ema.europa.eu/en/news/esubmission-gateway-now-live-all-applications-human-medicines-european-medicines-agency" }, { "title": "European Medicines Agency maintains recommendation not to grant a marketing authorisation for Glybera", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/04/2012", "last_updated_date": "20/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-maintains-recommendation-not-grant-marketing-authorisation-glybera" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012", "press_release": "No", "related_medicine_referral": "Toujeo (previously Optisulin);Lantus;Lantus;Gilenya", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/04/2012", "last_updated_date": "20/04/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-april-2012" }, { "title": "European Medicines Agency recommends authorisation of novel treatment for type-2 diabetes", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/04/2012", "last_updated_date": "20/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-novel-treatment-type-2-diabetes" }, { "title": "European Medicines Agency gives new advice to better manage risk of adverse effects on the heart with Gilenya", "press_release": "Yes", "related_medicine_referral": "Gilenya", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/04/2012", "last_updated_date": "20/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-new-advice-better-manage-risk-adverse-effects-heart-gilenya" }, { "title": "Agnès Saint Raymond appointed to UN Commission on life-saving commodities for women and children", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Paediatrics", "news_summary": "", "first_published_date": "16/04/2012", "last_updated_date": "16/04/2012", "news_url": "https://www.ema.europa.eu/en/news/agnes-saint-raymond-appointed-un-commission-life-saving-commodities-women-children" }, { "title": "Comments invited on the ICH E2C (R2) guideline on periodic benefit-risk evaluation report", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "16/04/2012", "last_updated_date": "16/04/2012", "news_url": "https://www.ema.europa.eu/en/news/comments-invited-ich-e2c-r2-guideline-periodic-benefit-risk-evaluation-report" }, { "title": "Towards a robust global framework for conduct and oversight of clinical trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "16/04/2012", "last_updated_date": "16/04/2012", "news_url": "https://www.ema.europa.eu/en/news/towards-robust-global-framework-conduct-oversight-clinical-trials" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 April 2012", "press_release": "Yes", "related_medicine_referral": "Convenia;Advocate;Econor;Rabigen SAG2;Spironolactone Ceva;Palladia;Netvax;Masivet;Certifect;BTVPUR AlSap 2-4;Equip WNV (previously Duvaxyn WNV)", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/04/2012", "last_updated_date": "16/04/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-april-2012" }, { "title": "European Medicines Agency publishes new document on regulatory procedural advice on similar biological medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Biologicals;Medicines", "news_summary": "", "first_published_date": "11/04/2012", "last_updated_date": "11/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-new-document-regulatory-procedural-advice-similar-biological-medicines" }, { "title": "European regulators propose way forward for publication of full clinical-trial data", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "11/04/2012", "last_updated_date": "11/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-regulators-propose-way-forward-publication-full-clinical-trial-data" }, { "title": "Eric Abadie resigns as chair of the CHMP", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/04/2012", "last_updated_date": "04/04/2012", "news_url": "https://www.ema.europa.eu/en/news/eric-abadie-resigns-chair-chmp" }, { "title": "Feedback requested on the draft list of EU reference dates for periodic safety update reports in preparation for introduction of the new pharmacovigilance legislation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "04/04/2012", "last_updated_date": "04/04/2012", "news_url": "https://www.ema.europa.eu/en/news/feedback-requested-draft-list-eu-reference-dates-periodic-safety-update-reports-preparation-introduction-new-pharmacovigilance-legislation" }, { "title": "World Health Day: 7 April 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/04/2012", "last_updated_date": "04/04/2012", "news_url": "https://www.ema.europa.eu/en/news/world-health-day-7-april-2012" }, { "title": "European Medicines Agency tightens conflicts-of-interests policies with immediate effect", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "03/04/2012", "last_updated_date": "03/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-tightens-conflicts-interests-policies-immediate-effect" }, { "title": "European Medicines Agency website unavailable 13.00-17:30 on 5 April 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "03/04/2012", "last_updated_date": "03/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-1300-1730-5-april-2012" }, { "title": "European Medicines Agency closed 5-9 April 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "03/04/2012", "last_updated_date": "03/04/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-5-9-april-2012" }, { "title": "Increased fees coming into effect on 1 April 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "30/03/2012", "last_updated_date": "30/03/2012", "news_url": "https://www.ema.europa.eu/en/news/increased-fees-coming-effect-1-april-2012" }, { "title": "European medicines regulators agree a common, Europe-wide approach for the identification of commercially confidential information and personal data", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/03/2012", "last_updated_date": "27/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-regulators-agree-common-europe-wide-approach-identification-commercially-confidential-information-personal-data" }, { "title": "EU Clinical Trials Register information now available through WHO's International Clinical Trials Registry Platform", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/03/2012", "last_updated_date": "26/03/2012", "news_url": "https://www.ema.europa.eu/en/news/eu-clinical-trials-register-information-now-available-through-whos-international-clinical-trials-registry-platform" }, { "title": "European Medicines Agency Management Board strengthens conflicts of interest policies and transparency", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/03/2012", "last_updated_date": "26/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-management-board-strengthens-conflicts-interest-policies-transparency" }, { "title": "European Medicines Agency holds workshop on vaccines development against Schmallenberg virus", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/03/2012", "last_updated_date": "22/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-holds-workshop-vaccines-development-against-schmallenberg-virus" }, { "title": "Astellas Pharma Europe B.V. withdraws its application for an extension of the indication for Qutenza (capsaicin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/03/2012", "last_updated_date": "20/03/2012", "news_url": "https://www.ema.europa.eu/en/news/astellas-pharma-europe-bv-withdraws-its-application-extension-indication-qutenza-capsaicin" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 March 2012", "press_release": "No", "related_medicine_referral": "Ibandronic Acid Teva;ProQuad;Ixiaro;Ceplene;Caelyx pegylated liposomal;Osseor;Protelos;Kogenate Bayer;Helixate NexGen", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/03/2012", "last_updated_date": "16/03/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-march-2012" }, { "title": "European Medicines Agency issues recommendations for 2012/2013 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/03/2012", "last_updated_date": "16/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-issues-recommendations-2012-2013-seasonal-flu-vaccine-composition" }, { "title": "European Medicines Agency recommends transfer of manufacturing sites for Caelyx and Ceplene", "press_release": "Yes", "related_medicine_referral": "Ceplene;Caelyx pegylated liposomal", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/03/2012", "last_updated_date": "16/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-transfer-manufacturing-sites-caelyx-ceplene" }, { "title": "European Medicines Agency confirms positive benefit-risk balance of Protelos / Osseor, but recommends new contraindications and revised warnings", "press_release": "Yes", "related_medicine_referral": "Protelos;Osseor", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/03/2012", "last_updated_date": "16/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-protelos-osseor-recommends-new-contraindications-revised-warnings" }, { "title": "Novartis Europharm Ltd withdraws its applications for an extension of the indication for Exelon and Prometax (rivastigmine)", "press_release": "Yes", "related_medicine_referral": "Exelon;Prometax", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "15/03/2012", "last_updated_date": "15/03/2012", "news_url": "https://www.ema.europa.eu/en/news/novartis-europharm-ltd-withdraws-its-applications-extension-indication-exelon-prometax-rivastigmine" }, { "title": "European Medicines Agency issues guidance on prevention of HIV transmission for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/03/2012", "last_updated_date": "15/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-issues-guidance-prevention-hiv-transmission-public-consultation" }, { "title": "Paper calls for continued support for development of advanced therapies", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Innovation", "news_summary": "", "first_published_date": "13/03/2012", "last_updated_date": "13/03/2012", "news_url": "https://www.ema.europa.eu/en/news/paper-calls-continued-support-development-advanced-therapies" }, { "title": "Alkermes Pharma Ireland Limited withdraws its marketing authorisation application for Megestrol Alkermes (megestrol)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "13/03/2012", "last_updated_date": "13/03/2012", "news_url": "https://www.ema.europa.eu/en/news/alkermes-pharma-ireland-limited-withdraws-its-marketing-authorisation-application-megestrol-alkermes-megestrol" }, { "title": "Survey launched for veterinarians on prescribing habits for antimicrobials", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "13/03/2012", "last_updated_date": "13/03/2012", "news_url": "https://www.ema.europa.eu/en/news/survey-launched-veterinarians-prescribing-habits-antimicrobials" }, { "title": "European Medicines Agency launches electronic application form pilot", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "12/03/2012", "last_updated_date": "12/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-electronic-application-form-pilot" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 March 2012", "press_release": "Yes", "related_medicine_referral": "Previcox;Improvac;CaniLeish;Procox;Veraflox;Zolvix;Meloxoral;Loxicom;Acticam;Improvac;Trocoxil;Circovac;Suprelorin;Spironolactone Ceva;Cerenia;Previcox;Aivlosin;Eurican Herpes 205;Nobilis IB 4-91", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/03/2012", "last_updated_date": "09/03/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-march-2012" }, { "title": "Committee for Advanced Therapies re-elects Christian Schneider as chair", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "09/03/2012", "last_updated_date": "09/03/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-re-elects-christian-schneider-chair" }, { "title": "World Kidney Day: 8 March 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "07/03/2012", "last_updated_date": "07/03/2012", "news_url": "https://www.ema.europa.eu/en/news/world-kidney-day-8-march-2012" }, { "title": "International collaboration on good manufacturing practice inspections expanded", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "06/03/2012", "last_updated_date": "06/03/2012", "news_url": "https://www.ema.europa.eu/en/news/international-collaboration-good-manufacturing-practice-inspections-expanded" }, { "title": "European Medicines Agency publishes updated set of mandatory Article 57(2) requirements for marketing authorisation holders", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Data on medicines;Medicines", "news_summary": "", "first_published_date": "05/03/2012", "last_updated_date": "05/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-updated-set-mandatory-article-572-requirements-marketing-authorisation-holders" }, { "title": "European Medicines Agency publishes list of human medicines under evaluation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "01/03/2012", "last_updated_date": "01/03/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-list-human-medicines-under-evaluation" }, { "title": "European Medicines Agency launches call for expression of interest from healthcare professional organisations", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "29/02/2012", "last_updated_date": "29/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-call-expression-interest-healthcare-professional-organisations" }, { "title": "European Medicines Agency increases public information on conflicts of interest of experts and management", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "29/02/2012", "last_updated_date": "29/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-increases-public-information-conflicts-interest-experts-management" }, { "title": "Rare Disease Day: 29 February 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/02/2012", "last_updated_date": "28/02/2012", "news_url": "https://www.ema.europa.eu/en/news/rare-disease-day-29-february-2012" }, { "title": "European Medicines Agency website intermittently offline 25-26 February 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/02/2012", "last_updated_date": "23/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-intermittently-offline-25-26-february-2012" }, { "title": "European Medicines Agency releases good pharmacovigilance practice modules for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/02/2012", "last_updated_date": "22/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-good-pharmacovigilance-practice-modules-public-consultation" }, { "title": "Information on transitional arrangements for pharmacovigilance legislation published", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/02/2012", "last_updated_date": "21/02/2012", "news_url": "https://www.ema.europa.eu/en/news/information-transitional-arrangements-pharmacovigilance-legislation-published" }, { "title": "European Medicines Agency focuses on new legislation in 2012 work programme", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/02/2012", "last_updated_date": "20/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-focuses-new-legislation-2012-work-programme" }, { "title": "European Medicines Agency to publish information on ongoing medicine evaluations", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2012", "last_updated_date": "17/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publish-information-ongoing-medicine-evaluations" }, { "title": "Adjusted fees for applications to European Medicines Agency from 1 April 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2012", "last_updated_date": "17/02/2012", "news_url": "https://www.ema.europa.eu/en/news/adjusted-fees-applications-european-medicines-agency-1-april-2012" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 2012", "press_release": "No", "related_medicine_referral": "Byetta;Humira;Halaven;Victrelis;Alli (previously Orlistat GSK);Xenical;Vistide;Vidaza;Vibativ;Velcade;Torisel;Soliris;Mepact;Luminity;Aclasta;Cayston;Busilvex;Angiox;Rasitrio;Sprimeo HCT;Riprazo HCT;Rasilez HCT;Rasilamlo;Sprimeo;Riprazo;Rasilez;ViraferonPeg;Rebetol;PegIntron", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "17/02/2012", "last_updated_date": "17/02/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-february-2012" }, { "title": "European Medicines Agency recommends conditional approval of Pixuvri (pixantrone) for relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma", "press_release": "Yes", "related_medicine_referral": "Pixuvri", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2012", "last_updated_date": "17/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-conditional-approval-pixuvri-pixantrone-relapsed-or-refractory-aggressive-non-hodgkins-b-cell-lymphoma" }, { "title": "European Medicines Agency recommends new anti-malaria treatment for use outside the European Union", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2012", "last_updated_date": "17/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-anti-malaria-treatment-use-outside-european-union" }, { "title": "European Medicines Agency concludes review of dose recommendations for anti-tuberculosis medicines used in children", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "17/02/2012", "last_updated_date": "17/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-review-dose-recommendations-anti-tuberculosis-medicines-used-children" }, { "title": "European Medicines Agency recommends lifting suspension of aprotinin", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2012", "last_updated_date": "17/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-lifting-suspension-aprotinin" }, { "title": "European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines", "press_release": "Yes", "related_medicine_referral": "Riprazo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2012", "last_updated_date": "17/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-contraindications-warnings-aliskiren-containing-medicines" }, { "title": "European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories", "press_release": "Yes", "related_medicine_referral": "Velcade;Cayston;Busilvex;Angiox;Vibativ;Soliris;Vistide;Mepact;Torisel", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/02/2012", "last_updated_date": "16/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-final-recommendations-12-centrally-authorised-medicines-manufactured-ben-venue-laboratories" }, { "title": "European Medicines Agency informs doctors and patients about drug interaction between Victrelis and ritonavir-boosted HIV protease inhibitors", "press_release": "Yes", "related_medicine_referral": "Victrelis", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/02/2012", "last_updated_date": "16/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-informs-doctors-patients-about-drug-interaction-between-victrelis-ritonavir-boosted-hiv-protease-inhibitors" }, { "title": "European Medicines Agency confirms positive benefit-risk balance of orlistat-containing medicines", "press_release": "Yes", "related_medicine_referral": "Xenical;Alli (previously Orlistat GSK)", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/02/2012", "last_updated_date": "16/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-orlistat-containing-medicines" }, { "title": "GlaxoSmithKline withdraws its application for an extension of the indication for Tyverb (lapatinib)", "press_release": "Yes", "related_medicine_referral": "Tyverb", "categories": "", "topics": "", "news_summary": "", "first_published_date": "16/02/2012", "last_updated_date": "16/02/2012", "news_url": "https://www.ema.europa.eu/en/news/glaxosmithkline-withdraws-its-application-extension-indication-tyverb-lapatinib" }, { "title": "Novartis Vaccines and Diagnostics S.r.l. withdraws its application for paediatric use marketing authorisation for Fluad Paediatric (influenza vaccine)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Paediatrics;Vaccines", "news_summary": "", "first_published_date": "16/02/2012", "last_updated_date": "16/02/2012", "news_url": "https://www.ema.europa.eu/en/news/novartis-vaccines-diagnostics-srl-withdraws-its-application-paediatric-use-marketing-authorisation-fluad-paediatric-influenza-vaccine" }, { "title": "European Medicines Agency welcomes new Head of Information and Communications Technology", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "16/02/2012", "last_updated_date": "16/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-information-communications-technology" }, { "title": "European Medicines Agency and European Commission extend confidentiality arrangement with Japan", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "14/02/2012", "last_updated_date": "14/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-commission-extend-confidentiality-arrangement-japan" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 February 2012", "press_release": "Yes", "related_medicine_referral": "Nobilis IB 4-91;BTVPUR Alsap 8;Masivet;Zulvac 1+8 Ovis;Cimalgex;BTVPUR Alsap 8;Bluevac BTV (previously Bluevac BTV8);Slentrol;BTVPUR;BTVPUR AlSap 1;Nobilis IB 4-91;MS-H Vaccine", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/02/2012", "last_updated_date": "10/02/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-february-2012" }, { "title": "European Medicines Agency publishes guideline on use of pharmacogenetics in evaluating pharmacokinetics of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "10/02/2012", "last_updated_date": "10/02/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-guideline-use-pharmacogenetics-evaluating-pharmacokinetics-medicines" }, { "title": "World Cancer Day: 4 February 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/02/2012", "last_updated_date": "03/02/2012", "news_url": "https://www.ema.europa.eu/en/news/world-cancer-day-4-february-2012" }, { "title": "Better protection of public health: European Medicines Agency counts down to introduction of new pharmacovigilance legislation", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "02/02/2012", "last_updated_date": "02/02/2012", "news_url": "https://www.ema.europa.eu/en/news/better-protection-public-health-european-medicines-agency-counts-down-introduction-new-pharmacovigilance-legislation" }, { "title": "European Medicines Agency and European Food Safety Authority commit to greater co-operation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/01/2012", "last_updated_date": "27/01/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-food-safety-authority-commit-greater-co-operation" }, { "title": "Public consultation open on concept paper on pharmacogenomics in evaluation of authorised medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/01/2012", "last_updated_date": "23/01/2012", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-open-concept-paper-pharmacogenomics-evaluation-authorised-medicines" }, { "title": "European Medicines Agency recommends suspension of marketing authorisations for meprobamate-containing medicines in the European Union", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/01/2012", "last_updated_date": "20/01/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisations-meprobamate-containing-medicines-european-union" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 January 2012", "press_release": "No", "related_medicine_referral": "Velcade;Remicade;Gilenya;RotaTeq;Meprobamate", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/01/2012", "last_updated_date": "20/01/2012", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-january-2012" }, { "title": "European Medicines Agency recommends approval of new medicine for Cushing's disease", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/01/2012", "last_updated_date": "20/01/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-new-medicine-cushings-disease" }, { "title": "European Medicines Agency releases guideline on biosimilar interferon beta for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Biosimilars;Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "20/01/2012", "last_updated_date": "20/01/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-guideline-biosimilar-interferon-beta-public-consultation" }, { "title": "European Medicines Agency starts review of Gilenya (fingolimod)", "press_release": "Yes", "related_medicine_referral": "Gilenya", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/01/2012", "last_updated_date": "20/01/2012", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-review-gilenya-fingolimod" }, { "title": "Committee for Orphan Medicinal Products (COMP) January 2012 highlights", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases;Rare diseases", "news_summary": "", "first_published_date": "16/01/2012", "last_updated_date": "16/01/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-comp-january-2012-highlights" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 January 2012", "press_release": "Yes", "related_medicine_referral": "Easotic;BTVPUR AlSap 2-4;Rhiniseng;Meloxidyl;Melovem;Ingelvac CircoFLEX;Coxevac;Comfortis;Bovilis BTV8", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/01/2012", "last_updated_date": "13/01/2012", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-january-2012" }, { "title": "Public consultation opens on the revised guideline on the evaluation of human anticancer medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "11/01/2012", "last_updated_date": "11/01/2012", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-opens-revised-guideline-evaluation-human-anticancer-medicines" }, { "title": "European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study", "press_release": "Yes", "related_medicine_referral": "Riprazo", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/12/2011", "last_updated_date": "22/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-review-aliskiren-containing-medicines-following-termination-altitude-study" }, { "title": "New measures to facilitate conduct of ENCePP studies", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/12/2011", "last_updated_date": "22/12/2011", "news_url": "https://www.ema.europa.eu/en/news/new-measures-facilitate-conduct-encepp-studies" }, { "title": "Committee on Herbal Medicinal Products approves four-year work programme", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal;Herbal", "topics": "", "news_summary": "", "first_published_date": "22/12/2011", "last_updated_date": "22/12/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-herbal-medicinal-products-approves-four-year-work-programme" }, { "title": "European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/12/2011", "last_updated_date": "21/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-somatropin-containing-medicines" }, { "title": "European Medicines Agency formalises interaction with healthcare professionals", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/12/2011", "last_updated_date": "19/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-formalises-interaction-healthcare-professionals" }, { "title": "European Medicines Agency issues revised guidance on genotoxicity testing of medicines", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "19/12/2011", "last_updated_date": "19/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-issues-revised-guidance-genotoxicity-testing-medicines" }, { "title": "European Medicines Agency closed 23 December 2011 to 2 January 2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/12/2011", "last_updated_date": "19/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-23-december-2011-2-january-2012" }, { "title": "European Medicines Agency's Management Board endorses work programme 2012", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "16/12/2011", "last_updated_date": "16/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-endorses-work-programme-2012" }, { "title": "European Medicines Agency recommends authorisation of Vimpat syrup for patients who cannot swallow tablets", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/12/2011", "last_updated_date": "16/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-vimpat-syrup-patients-who-cannot-swallow-tablets" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2011", "press_release": "No", "related_medicine_referral": "Xiliarx;Jalra;Galvus;Procoralan;Corlentor;Vimpat;NutropinAq;Omnitrope;Valtropin;Somatropin", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/12/2011", "last_updated_date": "16/12/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-december-2011" }, { "title": "European Medicines Agency recommends approval of first-in-class treatment for metastatic or unresectable melanoma", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/12/2011", "last_updated_date": "16/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-first-class-treatment-metastatic-or-unresectable-melanoma" }, { "title": "European Medicines Agency to continue to involve patients in scientific discussions on human medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "15/12/2011", "last_updated_date": "15/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-continue-involve-patients-scientific-discussions-human-medicines" }, { "title": "General Court upholds European Medicines Agency decision to refuse paediatric waiver for perflubutane", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "15/12/2011", "last_updated_date": "15/12/2011", "news_url": "https://www.ema.europa.eu/en/news/general-court-upholds-european-medicines-agency-decision-refuse-paediatric-waiver-perflubutane" }, { "title": "Committee for Orphan Medicinal Products (COMP) December highlights", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases;Rare diseases", "news_summary": "", "first_published_date": "13/12/2011", "last_updated_date": "13/12/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-comp-december-highlights" }, { "title": "European Medicines Agency recommends precautionary recall of remaining batch of Vistide manufactured at Ben Venue Laboratories", "press_release": "Yes", "related_medicine_referral": "Velcade;Cayston;Busilvex;Angiox;Vibativ;Caelyx pegylated liposomal;Soliris;Vistide;Mepact;Ceplene;Torisel", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "13/12/2011", "last_updated_date": "13/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-precautionary-recall-remaining-batch-vistide-manufactured-ben-venue-laboratories" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 December 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/12/2011", "last_updated_date": "09/12/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-december-2011" }, { "title": "European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories", "press_release": "Yes", "related_medicine_referral": "Velcade;Cayston;Angiox;Vibativ;Caelyx pegylated liposomal;Soliris;Vistide;Mepact;Ceplene;Torisel;Busilvex", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "09/12/2011", "last_updated_date": "09/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-further-interim-recommendations-dealing-shortcomings-quality-assurance-ben-venue-laboratories" }, { "title": "European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "09/12/2011", "last_updated_date": "09/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-united-states-food-drug-administration-share-manufacturing-site-inspections" }, { "title": "Experts and regulators discuss role of modelling and simulation in medicine development and regulatory assessment", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "07/12/2011", "last_updated_date": "07/12/2011", "news_url": "https://www.ema.europa.eu/en/news/experts-regulators-discuss-role-modelling-simulation-medicine-development-regulatory-assessment" }, { "title": "Fees for type IA variations to be due at start of procedure", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Fees", "news_summary": "", "first_published_date": "02/12/2011", "last_updated_date": "02/12/2011", "news_url": "https://www.ema.europa.eu/en/news/fees-type-ia-variations-be-due-start-procedure" }, { "title": "European Medicines Agency hosts workshop on ethics in paediatric clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "02/12/2011", "last_updated_date": "02/12/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-hosts-workshop-ethics-paediatric-clinical-trials" }, { "title": "Registration open for Committee for Advanced Therapies stakeholders workshop", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "30/11/2011", "last_updated_date": "30/11/2011", "news_url": "https://www.ema.europa.eu/en/news/registration-open-committee-advanced-therapies-stakeholders-workshop" }, { "title": "World AIDS Day: 1 December 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "30/11/2011", "last_updated_date": "30/11/2011", "news_url": "https://www.ema.europa.eu/en/news/world-aids-day-1-december-2011" }, { "title": "European Medicines Agency hosts first workshop on subgroup analysis", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "24/11/2011", "last_updated_date": "24/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-hosts-first-workshop-subgroup-analysis" }, { "title": "European Medicines Agency invites registrations for eSubmission Gateway", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/11/2011", "last_updated_date": "23/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-invites-registrations-esubmission-gateway" }, { "title": "European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories", "press_release": "Yes", "related_medicine_referral": "Velcade;Cayston;Angiox;Vibativ;Caelyx pegylated liposomal;Soliris;Vistide;Mepact;Ceplene;Torisel;Busilvex", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/11/2011", "last_updated_date": "22/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-interim-recommendations-deal-shortcomings-quality-assurance-ben-venue-laboratories" }, { "title": "Andreas Pott appointed Deputy Executive Director of European Medicines Agency", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/11/2011", "last_updated_date": "18/11/2011", "news_url": "https://www.ema.europa.eu/en/news/andreas-pott-appointed-deputy-executive-director-european-medicines-agency" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 November 2011", "press_release": "No", "related_medicine_referral": "Pradaxa;Herceptin;Erbitux;Nodetrip (previously Xeristar);Cymbalta;Ariclaim;Rebif;Nevanac", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "18/11/2011", "last_updated_date": "18/11/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-november-2011" }, { "title": "European Medicines Agency confirms positive benefit-risk balance of pholcodine-containing cough medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/11/2011", "last_updated_date": "18/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-pholcodine-containing-cough-medicines" }, { "title": "European Medicines Agency updates on safety of Pradaxa", "press_release": "Yes", "related_medicine_referral": "Pradaxa", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/11/2011", "last_updated_date": "18/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-safety-pradaxa" }, { "title": "European Medicines Agency recommends suspension of all buflomedil-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/11/2011", "last_updated_date": "17/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-all-buflomedil-containing-medicines" }, { "title": "European Antibiotic Awareness Day: 18 November 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/11/2011", "last_updated_date": "17/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-18-november-2011" }, { "title": "European Medicines Agency welcomes new Head of Finance and Budget", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "17/11/2011", "last_updated_date": "17/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-head-finance-budget" }, { "title": "Guido Rasi begins as new head of European Medicines Agency", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "16/11/2011", "last_updated_date": "16/11/2011", "news_url": "https://www.ema.europa.eu/en/news/guido-rasi-begins-new-head-european-medicines-agency" }, { "title": "Dyax s.a. withdraws its marketing authorisation application for Kalbitor (ecallantide)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/11/2011", "last_updated_date": "15/11/2011", "news_url": "https://www.ema.europa.eu/en/news/dyax-sa-withdraws-its-marketing-authorisation-application-kalbitor-ecallantide" }, { "title": "Merck Sharp & Dohme (Europe), Inc. withdraws its marketing authorisation application for Janacti (sitagliptin and pioglitazone) and related trade names", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/11/2011", "last_updated_date": "14/11/2011", "news_url": "https://www.ema.europa.eu/en/news/merck-sharp-dohme-europe-inc-withdraws-its-marketing-authorisation-application-janacti-sitagliptin-pioglitazone-related-trade-names" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 November 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/11/2011", "last_updated_date": "11/11/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-november-2011" }, { "title": "World Diabetes Day: 14 November 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "11/11/2011", "last_updated_date": "11/11/2011", "news_url": "https://www.ema.europa.eu/en/news/world-diabetes-day-14-november-2011" }, { "title": "European and international experts discuss the way forward in developing ophthalmology medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/11/2011", "last_updated_date": "04/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-international-experts-discuss-way-forward-developing-ophthalmology-medicines" }, { "title": "European Medicines Agency meetings to be held offsite during 2012 Olympics", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "04/11/2011", "last_updated_date": "04/11/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-meetings-be-held-offsite-during-2012-olympics" }, { "title": "Expressions of interest invited for workshop on medicines for older people", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/11/2011", "last_updated_date": "03/11/2011", "news_url": "https://www.ema.europa.eu/en/news/expressions-interest-invited-workshop-medicines-older-people" }, { "title": "European Medicines Agency simplifies SME assignment process", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines;SME", "news_summary": "", "first_published_date": "28/10/2011", "last_updated_date": "28/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-simplifies-sme-assignment-process" }, { "title": "Assessment templates updated to include information on geriatric studies and new active substance claims", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/10/2011", "last_updated_date": "28/10/2011", "news_url": "https://www.ema.europa.eu/en/news/assessment-templates-updated-include-information-geriatric-studies-new-active-substance-claims" }, { "title": "European Medicines Agency closed 31 October to 2 November 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/10/2011", "last_updated_date": "27/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-31-october-2-november-2011" }, { "title": "European Medicines Agency reiterates support for staff member", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/10/2011", "last_updated_date": "26/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reiterates-support-staff-member" }, { "title": "European Medicines Agency's 2009 budget approved", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "25/10/2011", "last_updated_date": "25/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-2009-budget-approved" }, { "title": "Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/10/2011", "last_updated_date": "25/10/2011", "news_url": "https://www.ema.europa.eu/en/news/xigris-drotrecogin-alfa-activated-be-withdrawn-due-lack-efficacy" }, { "title": "European Medicines Agency clarifies opinion on pioglitazone and the risk of bladder cancer", "press_release": "Yes", "related_medicine_referral": "Actos;Glustin;Glubrava;Tandemact;Competact", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/10/2011", "last_updated_date": "21/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-clarifies-opinion-pioglitazone-risk-bladder-cancer" }, { "title": "European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/10/2011", "last_updated_date": "21/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-new-review-cardiovascular-risks-non-selective-nsaids" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011", "press_release": "No", "related_medicine_referral": "Protelos;Osseor;Actos;Telmisartan Teva Pharma;Ifirmacombi;Tolura;Irbesartan Teva;Exforge HCT;Twynsta;Irbesartan/Hydrochlorothiazide Teva;Telmisartan Teva;Telmisartan Actavis;Copalia HCT;Dafiro HCT;Imprida HCT;Glubrava;Tandemact;Competact;Glustin;Actos;Advagraf;Exforge;Imprida;Dafiro;Copalia;PritorPlus;MicardisPlus;Kinzalkomb;Karvezide;Karvea;Irbesartan Zentiva (previously Irbesartan Winthrop);Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop);Ifirmasta (previously Irbesartan Krka);CoAprovel;Aprovel;Micardis;Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG);Pritor;Cervarix;Onglyza", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/10/2011", "last_updated_date": "21/10/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-october-2011" }, { "title": "European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive", "press_release": "Yes", "related_medicine_referral": "Pritor;Micardis;Exforge;Dafiro;Copalia;PritorPlus;MicardisPlus;Kinzalkomb;Karvezide;Karvea;Irbesartan Zentiva (previously Irbesartan Winthrop);Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop);Ifirmasta (previously Irbesartan Krka);CoAprovel;Aprovel;Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG);Exforge HCT;Imprida HCT;Dafiro HCT;Copalia HCT;Twynsta;Tolura;Telmisartan Teva Pharma;Telmisartan Teva;Telmisartan Actavis;Irbesartan Teva;Irbesartan/Hydrochlorothiazide Teva;Ifirmacombi;Imprida", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/10/2011", "last_updated_date": "20/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-benefit-risk-balance-angiotensin-ii-receptor-antagonists-remains-positive" }, { "title": "European Medicines Agency agrees to precautionary recall of Advagraf 0.5 mg capsule batches", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/10/2011", "last_updated_date": "20/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-agrees-precautionary-recall-advagraf-05-mg-capsule-batches" }, { "title": "European Medicines Agency starts review of Protelos / Osseor", "press_release": "Yes", "related_medicine_referral": "Protelos;Osseor", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/10/2011", "last_updated_date": "20/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-review-protelos-osseor" }, { "title": "Krka, d.d., Novo mesto withdraws its marketing authorisation application for Desloratadine Krka (desloratadine)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/10/2011", "last_updated_date": "19/10/2011", "news_url": "https://www.ema.europa.eu/en/news/krka-dd-novo-mesto-withdraws-its-marketing-authorisation-application-desloratadine-krka-desloratadine" }, { "title": "Lux Biosciences GmbH withdraws its marketing authorisation application for Luveniq (voclosporin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/10/2011", "last_updated_date": "18/10/2011", "news_url": "https://www.ema.europa.eu/en/news/lux-biosciences-gmbh-withdraws-its-marketing-authorisation-application-luveniq-voclosporin" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 October 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/10/2011", "last_updated_date": "14/10/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-october-2011" }, { "title": "European Medicines Agency releases qualification opinion on diagnosis of pre-dementia Alzheimer's for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "12/10/2011", "last_updated_date": "12/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-qualification-opinion-diagnosis-pre-dementia-alzheimers-public-consultation" }, { "title": "World Arthritis Day: 12 October 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "11/10/2011", "last_updated_date": "11/10/2011", "news_url": "https://www.ema.europa.eu/en/news/world-arthritis-day-12-october-2011" }, { "title": "European Medicines Agency launches database of clinical studies in children completed before 2007", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "11/10/2011", "last_updated_date": "11/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-database-clinical-studies-children-completed-2007" }, { "title": "European Medicines Agency's Management Board officially appoints Guido Rasi as new Executive Director", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "07/10/2011", "last_updated_date": "07/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-officially-appoints-guido-rasi-new-executive-director" }, { "title": "European Medicines Agency invites feedback on plans to revise existing guidelines on biosimilar medicines and influenza vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Biosimilars;Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "03/10/2011", "last_updated_date": "03/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-invites-feedback-plans-revise-existing-guidelines-biosimilar-medicines-influenza-vaccines" }, { "title": "Expressions of interest invited for membership of European Medicines Agency committees and Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/10/2011", "last_updated_date": "03/10/2011", "news_url": "https://www.ema.europa.eu/en/news/expressions-interest-invited-membership-european-medicines-agency-committees-management-board" }, { "title": "European SME Week: 3-9 October 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "SME", "news_summary": "", "first_published_date": "03/10/2011", "last_updated_date": "03/10/2011", "news_url": "https://www.ema.europa.eu/en/news/european-sme-week-3-9-october-2011" }, { "title": "European Medicines Agency launches new database of European experts", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "30/09/2011", "last_updated_date": "30/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-new-database-european-experts" }, { "title": "World Heart Day: 29 September 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/09/2011", "last_updated_date": "28/09/2011", "news_url": "https://www.ema.europa.eu/en/news/world-heart-day-29-september-2011" }, { "title": "European Medicines Agency replies to concerns of Sane Vax Inc.", "press_release": "No", "related_medicine_referral": "Gardasil", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2011", "last_updated_date": "23/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-replies-concerns-sane-vax-inc" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 2011", "press_release": "No", "related_medicine_referral": "Multaq;Revlimid;Cinryze;Vimpat;Alimta;Apidra;Levemir;Victoza;Soliris;Xarelto;Alli (previously Orlistat GSK);Avastin;Prevenar 13", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "23/09/2011", "last_updated_date": "23/09/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-september-2011" }, { "title": "European Medicines Agency recommends authorisation of novel antibiotic agent", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2011", "last_updated_date": "23/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-novel-antibiotic-agent" }, { "title": "European Medicines Agency recommends contraindications for suppositories containing terpenic derivatives", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2011", "last_updated_date": "23/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-contraindications-suppositories-containing-terpenic-derivatives" }, { "title": "European Medicines Agency concludes that benefit-risk balance of Revlimid remains positive", "press_release": "Yes", "related_medicine_referral": "Revlimid", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2011", "last_updated_date": "23/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-benefit-risk-balance-revlimid-remains-positive" }, { "title": "European Medicines Agency finalises review of Baxter's dialysis solutions", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2011", "last_updated_date": "23/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-review-baxters-dialysis-solutions" }, { "title": "European Medicines Agency website unavailable 23-25 September 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2011", "last_updated_date": "23/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-23-25-september-2011" }, { "title": "European Medicines Agency starts review of orlistat-containing medicines", "press_release": "Yes", "related_medicine_referral": "Xenical;Alli (previously Orlistat GSK)", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/09/2011", "last_updated_date": "22/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-review-orlistat-containing-medicines" }, { "title": "European Medicines Agency recommends discontinuation of Vimpat 15-mg/ml syrup", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/09/2011", "last_updated_date": "22/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-discontinuation-vimpat-15-mg-ml-syrup" }, { "title": "European Medicines Agency recommends restricting use of Multaq", "press_release": "Yes", "related_medicine_referral": "Multaq", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/09/2011", "last_updated_date": "22/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-multaq" }, { "title": "World Alzheimer's Day: 21 September 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/09/2011", "last_updated_date": "20/09/2011", "news_url": "https://www.ema.europa.eu/en/news/world-alzheimers-day-21-september-2011" }, { "title": "European Medicines Agency publishes first report on sales of veterinary antimicrobial agents", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/09/2011", "last_updated_date": "19/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-first-report-sales-veterinary-antimicrobial-agents" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 September 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/09/2011", "last_updated_date": "16/09/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-september-2011" }, { "title": "EU Clinical Trials Register recognised as 'primary registry' of WHO's International Clinical Trials Registry Platform", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/09/2011", "last_updated_date": "14/09/2011", "news_url": "https://www.ema.europa.eu/en/news/eu-clinical-trials-register-recognised-primary-registry-whos-international-clinical-trials-registry-platform" }, { "title": "Concept paper on pharmacovigilance implementing measures released for consultation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/09/2011", "last_updated_date": "08/09/2011", "news_url": "https://www.ema.europa.eu/en/news/concept-paper-pharmacovigilance-implementing-measures-released-consultation" }, { "title": "CHMP meets to discuss Multaq", "press_release": "No", "related_medicine_referral": "Multaq", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/09/2011", "last_updated_date": "02/09/2011", "news_url": "https://www.ema.europa.eu/en/news/chmp-meets-discuss-multaq" }, { "title": "European Medicines Agency provides update on electronic submission of information on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "01/09/2011", "last_updated_date": "01/09/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-provides-update-electronic-submission-information-medicines" }, { "title": "CHMP meeting to discuss Multaq on Friday 2 September", "press_release": "No", "related_medicine_referral": "Multaq", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "01/09/2011", "last_updated_date": "01/09/2011", "news_url": "https://www.ema.europa.eu/en/news/chmp-meeting-discuss-multaq-friday-2-september" }, { "title": "European Medicines Agency closed 29 August 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/08/2011", "last_updated_date": "26/08/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-29-august-2011" }, { "title": "New validation criteria for electronic submissions from 1 September 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/08/2011", "last_updated_date": "19/08/2011", "news_url": "https://www.ema.europa.eu/en/news/new-validation-criteria-electronic-submissions-1-september-2011" }, { "title": "European Medicines Agency website unavailable Saturday 13 August", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "10/08/2011", "last_updated_date": "10/08/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-unavailable-saturday-13-august" }, { "title": "European Medicines Agency signs lease for new office space", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "09/08/2011", "last_updated_date": "09/08/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-signs-lease-new-office-space" }, { "title": "European Medicines Agency and its international partners complete successful inspection pilots", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "02/08/2011", "last_updated_date": "02/08/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-its-international-partners-complete-successful-inspection-pilots" }, { "title": "Identifying research priorities for the study of drug-related progressive multifocal leukoencephalopathy (PML)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/07/2011", "last_updated_date": "28/07/2011", "news_url": "https://www.ema.europa.eu/en/news/identifying-research-priorities-study-drug-related-progressive-multifocal-leukoencephalopathy-pml" }, { "title": "Software development companies invited to express interest in workshop on electronic prescribing", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/07/2011", "last_updated_date": "27/07/2011", "news_url": "https://www.ema.europa.eu/en/news/software-development-companies-invited-express-interest-workshop-electronic-prescribing" }, { "title": "Hexal AG withdraws its marketing authorisation application for Ibandronic acid Hexal (ibandronic acid)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/07/2011", "last_updated_date": "27/07/2011", "news_url": "https://www.ema.europa.eu/en/news/hexal-ag-withdraws-its-marketing-authorisation-application-ibandronic-acid-hexal-ibandronic-acid" }, { "title": "Expressions of interest invited for workshop on ethics of clinical trials in children", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "26/07/2011", "last_updated_date": "26/07/2011", "news_url": "https://www.ema.europa.eu/en/news/expressions-interest-invited-workshop-ethics-clinical-trials-children" }, { "title": "European Medicines Agency publishes new strategy on combating antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "25/07/2011", "last_updated_date": "25/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-new-strategy-combating-antimicrobial-resistance" }, { "title": "European Medicines Agency improves package leaflets", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Product information", "news_summary": "", "first_published_date": "22/07/2011", "last_updated_date": "22/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-improves-package-leaflets" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "22/07/2011", "last_updated_date": "22/07/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-july-2011" }, { "title": "European Medicines Agency agrees to recall of Vimpat 15-mg/ml syrup", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/07/2011", "last_updated_date": "22/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-agrees-recall-vimpat-15-mg-ml-syrup" }, { "title": "European Medicines Agency updates on ongoing benefit-risk review of Multaq", "press_release": "Yes", "related_medicine_referral": "Multaq", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/07/2011", "last_updated_date": "21/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-ongoing-benefit-risk-review-multaq" }, { "title": "European Medicines Agency confirms positive benefit-risk balance for Champix", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/07/2011", "last_updated_date": "21/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-champix" }, { "title": "European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer", "press_release": "Yes", "related_medicine_referral": "Actos;Glustin;Glubrava;Tandemact;Competact", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "21/07/2011", "last_updated_date": "21/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-contra-indications-warnings-pioglitazone-reduce-small-increased-risk-bladder-cancer" }, { "title": "European Medicines Agency recommends restricting use of Pandemrix", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "21/07/2011", "last_updated_date": "21/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-pandemrix" }, { "title": "Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Doxorubicin Sun (doxorubicin hydrochloride)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/07/2011", "last_updated_date": "21/07/2011", "news_url": "https://www.ema.europa.eu/en/news/sun-pharmaceutical-industries-europe-bv-withdraws-its-marketing-authorisation-application-doxorubicin-sun-doxorubicin-hydrochloride" }, { "title": "Pfizer Limited withdraws its application for an extension of the indication for Macugen (pegaptanib sodium)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/07/2011", "last_updated_date": "19/07/2011", "news_url": "https://www.ema.europa.eu/en/news/pfizer-limited-withdraws-its-application-extension-indication-macugen-pegaptanib-sodium" }, { "title": "Public consultation opens on the revised guideline on good distribution practice of medicinal products for human use", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections;Regulatory and procedural guidance", "news_summary": "", "first_published_date": "19/07/2011", "last_updated_date": "19/07/2011", "news_url": "https://www.ema.europa.eu/en/news/public-consultation-opens-revised-guideline-good-distribution-practice-medicinal-products-human-use" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 12-14 July 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/07/2011", "last_updated_date": "15/07/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-12-14-july-2011" }, { "title": "European Medicines Agency responds to criticism of staff member", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "14/07/2011", "last_updated_date": "14/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-responds-criticism-staff-member" }, { "title": "European Medicines Agency seeks views on genomic markers in medicine development", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "13/07/2011", "last_updated_date": "13/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-seeks-views-genomic-markers-medicine-development" }, { "title": "European Medicines Agency reviews cardiovascular risk of Multaq", "press_release": "Yes", "related_medicine_referral": "Multaq", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "11/07/2011", "last_updated_date": "11/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reviews-cardiovascular-risk-multaq" }, { "title": "Registration open for conference on advanced therapies", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/07/2011", "last_updated_date": "08/07/2011", "news_url": "https://www.ema.europa.eu/en/news/registration-open-conference-advanced-therapies" }, { "title": "European Medicines Agency plans public access to information on side effects", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "08/07/2011", "last_updated_date": "08/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-plans-public-access-information-side-effects" }, { "title": "European Medicines Agency invites expressions of interest for ophthalmology workshop", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "06/07/2011", "last_updated_date": "06/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-invites-expressions-interest-ophthalmology-workshop" }, { "title": "European Medicines Agency welcomes new rules on falsified medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "04/07/2011", "last_updated_date": "04/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-rules-falsified-medicines" }, { "title": "European Medicines Agency hosts meeting with European Parliament representatives", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "01/07/2011", "last_updated_date": "01/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-hosts-meeting-european-parliament-representatives" }, { "title": "European Medicines Agency publishes format for submission of information on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "01/07/2011", "last_updated_date": "01/07/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-format-submission-information-medicines" }, { "title": "European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) sees rapid growth", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "30/06/2011", "last_updated_date": "30/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-network-centres-pharmacoepidemiology-pharmacovigilance-encepp-sees-rapid-growth" }, { "title": "European Medicines Agency's 2010 annual report shows increase in activities", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "29/06/2011", "last_updated_date": "29/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-2010-annual-report-shows-increase-activities" }, { "title": "European Medicines Agency listens to stakeholder expectations for pharmacovigilance reforms", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "24/06/2011", "last_updated_date": "24/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-listens-stakeholder-expectations-pharmacovigilance-reforms" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "24/06/2011", "last_updated_date": "24/06/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp20-23-june-2011" }, { "title": "European Medicines Agency recommends new malaria treatment for approval", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/06/2011", "last_updated_date": "24/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-malaria-treatment-approval" }, { "title": "European Medicines Agency recommends restricting the use of dexrazoxane-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/06/2011", "last_updated_date": "24/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-dexrazoxane-containing-medicines" }, { "title": "European Medicines Agency gives first positive opinion for paediatric-use marketing authorisation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/06/2011", "last_updated_date": "24/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-first-positive-opinion-paediatric-use-marketing-authorisation" }, { "title": "European Medicines Agency and US Food and Drug Administration set up biosimilar 'cluster' and publish first report on interactions", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Biosimilars;Medicines", "news_summary": "", "first_published_date": "23/06/2011", "last_updated_date": "23/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-set-biosimilar-cluster-publish-first-report-interactions" }, { "title": "European Medicines Agency updates on ongoing benefit-risk review of pioglitazone–containing medicines", "press_release": "Yes", "related_medicine_referral": "Actos;Glustin;Competact;Glubrava;Tandemact", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/06/2011", "last_updated_date": "23/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-ongoing-benefit-risk-review-pioglitazone-containing-medicines" }, { "title": "European Medicines Agency concludes review of systemic nimesulide-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/06/2011", "last_updated_date": "23/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-review-systemic-nimesulide-containing-medicines" }, { "title": "European Medicines Agency holds first meeting of expert group on the replacement, reduction and refinement of the use of animals", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/06/2011", "last_updated_date": "22/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-holds-first-meeting-expert-group-replacement-reduction-refinement-use-animals" }, { "title": "European Medicines Agency and US Food and Drug Administration receive first parallel quality-by-design application", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "17/06/2011", "last_updated_date": "17/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-receive-first-parallel-quality-design-application" }, { "title": "European Medicines Agency closed 13 June 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "10/06/2011", "last_updated_date": "10/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-13-june-2011" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 7-9 June 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/06/2011", "last_updated_date": "10/06/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-june-2011" }, { "title": "European Medicines Agency Management Board elects Kent Woods as new chair", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/06/2011", "last_updated_date": "10/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-management-board-elects-kent-woods-new-chair" }, { "title": "Update on ongoing European review of pioglitazone–containing medicines", "press_release": "Yes", "related_medicine_referral": "Actos;Glustin;Glubrava;Tandemact;Competact", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "09/06/2011", "last_updated_date": "09/06/2011", "news_url": "https://www.ema.europa.eu/en/news/update-ongoing-european-review-pioglitazone-containing-medicines" }, { "title": "European Medicines Agency's Management Board nominates Guido Rasi as new Executive Director", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/06/2011", "last_updated_date": "08/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-nominates-guido-rasi-new-executive-director" }, { "title": "European Medicines Agency establishes Geriatric Expert Group", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "07/06/2011", "last_updated_date": "07/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-establishes-geriatric-expert-group" }, { "title": "European Medicines Agency responds to criticism over clinical trial reporting", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "06/06/2011", "last_updated_date": "06/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-responds-criticism-over-clinical-trial-reporting" }, { "title": "ENCePP publishes the 'guide on methodological standards in pharmacoepidemiology'", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/06/2011", "last_updated_date": "01/06/2011", "news_url": "https://www.ema.europa.eu/en/news/encepp-publishes-guide-methodological-standards-pharmacoepidemiology" }, { "title": "European Medicines Agency and Heads of Medicines Agencies propose measures to make information in application dossiers more transparent", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "01/06/2011", "last_updated_date": "01/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-heads-medicines-agencies-propose-measures-make-information-application-dossiers-more-transparent" }, { "title": "European Medicines Agency closed 2-3 June 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "01/06/2011", "last_updated_date": "01/06/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closed-2-3-june-2011" }, { "title": "European Medicines Agency marks 40th anniversary of PIC/S", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "31/05/2011", "last_updated_date": "31/05/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-marks-40th-anniversary-pic-s" }, { "title": "Study provides recommendations on European Medicines Agency's communication on medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "31/05/2011", "last_updated_date": "31/05/2011", "news_url": "https://www.ema.europa.eu/en/news/study-provides-recommendations-european-medicines-agencys-communication-medicines" }, { "title": "European Medicines Agency website updated with new pages", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "30/05/2011", "last_updated_date": "30/05/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-updated-new-pages" }, { "title": "Report and videos available from Enpr-EMA launch", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "27/05/2011", "last_updated_date": "27/05/2011", "news_url": "https://www.ema.europa.eu/en/news/report-videos-available-enpr-ema-launch" }, { "title": "European Medicines Agency recommends revaccination for some travellers in need of protection with Ixiaro", "press_release": "Yes", "related_medicine_referral": "Ixiaro", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/05/2011", "last_updated_date": "27/05/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-revaccination-some-travellers-need-protection-ixiaro" }, { "title": "European Medicines Agency responds to criticism over transparency in British Medical Journal", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/05/2011", "last_updated_date": "23/05/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-responds-criticism-over-transparency-british-medical-journal" }, { "title": "European Medicines Agency recommends suspension of oral buflomedil-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/05/2011", "last_updated_date": "20/05/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-oral-buflomedil-containing-medicines" }, { "title": "European Medicines Agency concludes on use of celecoxib in familial adenomatous polyposis", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/05/2011", "last_updated_date": "20/05/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-use-celecoxib-familial-adenomatous-polyposis" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "20/05/2011", "last_updated_date": "20/05/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-may-2011" }, { "title": "European Medicines Agency discusses pharmacovigilance with French General Inspectorate of Social Affairs", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/05/2011", "last_updated_date": "19/05/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-discusses-pharmacovigilance-french-general-inspectorate-social-affairs" }, { "title": "Report published from workshop on ethics and GCP in clinical trials outside the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "17/05/2011", "last_updated_date": "17/05/2011", "news_url": "https://www.ema.europa.eu/en/news/report-published-workshop-ethics-gcp-clinical-trials-outside-european-union" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 3-5 May 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "06/05/2011", "last_updated_date": "06/05/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-3-5-may-2011" }, { "title": "European Medicines Agency addresses development of new antibacterials", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/04/2011", "last_updated_date": "26/04/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-addresses-development-new-antibacterials" }, { "title": "NicOx S.A. withdraws its marketing authorisation application for Beprana (naproxcinod)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/04/2011", "last_updated_date": "20/04/2011", "news_url": "https://www.ema.europa.eu/en/news/nicox-sa-withdraws-its-marketing-authorisation-application-beprana-naproxcinod" }, { "title": "European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/04/2011", "last_updated_date": "20/04/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-holds-first-stakeholder-forum-implementation-new-pharmacovigilance-legislation" }, { "title": "Novartis withdraws its marketing authorisation application for Joicela (lumiracoxib)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/04/2011", "last_updated_date": "19/04/2011", "news_url": "https://www.ema.europa.eu/en/news/novartis-withdraws-its-marketing-authorisation-application-joicela-lumiracoxib" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 April 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "15/04/2011", "last_updated_date": "15/04/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-april-2011" }, { "title": "European Medicines Agency concludes class review of bisphosphonates and atypical fractures", "press_release": "Yes", "related_medicine_referral": "Bondronat;Bonviva;Bondenza (previously Ibandronic Acid Roche);Aclasta", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/04/2011", "last_updated_date": "15/04/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-class-review-bisphosphonates-atypical-fractures" }, { "title": "European Medicines Agency recommends interim measures for Pandemrix", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/04/2011", "last_updated_date": "15/04/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-interim-measures-pandemrix" }, { "title": "European Medicines Agency recommends lifting of suspension of Octagam", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "14/04/2011", "last_updated_date": "14/04/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-lifting-suspension-octagam" }, { "title": "European Medicines Agency issues reminder on PIP deferral obligations", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "13/04/2011", "last_updated_date": "13/04/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-issues-reminder-pip-deferral-obligations" }, { "title": "European Medicines Agency launches consultation on its position on replacement of animal studies", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "12/04/2011", "last_updated_date": "12/04/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-consultation-its-position-replacement-animal-studies" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 5-7 April 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/04/2011", "last_updated_date": "08/04/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-april-2011" }, { "title": "Registration open for EMA/EFPIA Info Day: 23 May 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/04/2011", "last_updated_date": "08/04/2011", "news_url": "https://www.ema.europa.eu/en/news/registration-open-ema-efpia-info-day-23-may-2011" }, { "title": "Reliance GeneMedix Plc. withdraws its marketing authorisation application for Epostim (erythropoietin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/04/2011", "last_updated_date": "06/04/2011", "news_url": "https://www.ema.europa.eu/en/news/reliance-genemedix-plc-withdraws-its-marketing-authorisation-application-epostim-erythropoietin" }, { "title": "Recommendations on labelling and packaging for non-prescription medicines released for consultation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Product information", "news_summary": "", "first_published_date": "02/04/2011", "last_updated_date": "02/04/2011", "news_url": "https://www.ema.europa.eu/en/news/recommendations-labelling-packaging-non-prescription-medicines-released-consultation" }, { "title": "Increased fees coming into effect on 1 April 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/03/2011", "last_updated_date": "29/03/2011", "news_url": "https://www.ema.europa.eu/en/news/increased-fees-coming-effect-1-april-2011" }, { "title": "European Medicines Agency closes PIM project", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "29/03/2011", "last_updated_date": "29/03/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-closes-pim-project" }, { "title": "Second phase of public SME register goes live", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "SME", "news_summary": "", "first_published_date": "25/03/2011", "last_updated_date": "25/03/2011", "news_url": "https://www.ema.europa.eu/en/news/second-phase-public-sme-register-goes-live" }, { "title": "European Medicines Agency launches survey to gather feedback on SME programme", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines;SME", "news_summary": "", "first_published_date": "24/03/2011", "last_updated_date": "24/03/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-survey-gather-feedback-sme-programme" }, { "title": "EU Clinical Trials Register goes live", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/03/2011", "last_updated_date": "23/03/2011", "news_url": "https://www.ema.europa.eu/en/news/eu-clinical-trials-register-goes-live" }, { "title": "Activities of former EMA Executive Director Thomas Lönngren", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/03/2011", "last_updated_date": "21/03/2011", "news_url": "https://www.ema.europa.eu/en/news/activities-former-ema-executive-director-thomas-lonngren" }, { "title": "European Medicines Agency announces start of process improvement of core business procedures", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/03/2011", "last_updated_date": "18/03/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-announces-start-process-improvement-core-business-procedures" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 March 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "18/03/2011", "last_updated_date": "18/03/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-march-2011" }, { "title": "Recommendations issued for 2011/2012 seasonal flu vaccine composition", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "17/03/2011", "last_updated_date": "17/03/2011", "news_url": "https://www.ema.europa.eu/en/news/recommendations-issued-2011-2012-seasonal-flu-vaccine-composition" }, { "title": "Registration open for PDA/EMA 2011 Conference: 3-5 May 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/03/2011", "last_updated_date": "17/03/2011", "news_url": "https://www.ema.europa.eu/en/news/registration-open-pda-ema-2011-conference-3-5-may-2011" }, { "title": "European Medicines Agency and US Food and Drug Administration announce pilot programme for parallel assessment of quality-by-design applications", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "16/03/2011", "last_updated_date": "16/03/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-announce-pilot-programme-parallel-assessment-quality-design-applications" }, { "title": "European Network of Paediatric Research at the European Medicines Agency introduced to wider audience", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "11/03/2011", "last_updated_date": "11/03/2011", "news_url": "https://www.ema.europa.eu/en/news/european-network-paediatric-research-european-medicines-agency-introduced-wider-audience" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 8-10 March 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/03/2011", "last_updated_date": "11/03/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-march-2011" }, { "title": "European Medicines Agency hosts training course for GCP inspectors from countries across the world", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "04/03/2011", "last_updated_date": "04/03/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-hosts-training-course-gcp-inspectors-countries-across-world" }, { "title": "European Medicines Agency releases updated guidance on insomnia treatments", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "26/02/2011", "last_updated_date": "26/02/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-releases-updated-guidance-insomnia-treatments" }, { "title": "Rare Disease Day: 28 February 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/02/2011", "last_updated_date": "25/02/2011", "news_url": "https://www.ema.europa.eu/en/news/rare-disease-day-28-february-2011" }, { "title": "Concept paper on medicines to prevent HIV infection released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/02/2011", "last_updated_date": "24/02/2011", "news_url": "https://www.ema.europa.eu/en/news/concept-paper-medicines-prevent-hiv-infection-released-public-consultation" }, { "title": "Adjusted fees for applications to European Medicines Agency on 1 April 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "24/02/2011", "last_updated_date": "24/02/2011", "news_url": "https://www.ema.europa.eu/en/news/adjusted-fees-applications-european-medicines-agency-1-april-2011" }, { "title": "European Medicines Agency launches strategy on medicines for older people", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/02/2011", "last_updated_date": "23/02/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-strategy-medicines-older-people" }, { "title": "Registration open for EMA/IFAH-Europe Info Day: 10-11 March 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/02/2011", "last_updated_date": "18/02/2011", "news_url": "https://www.ema.europa.eu/en/news/registration-open-ema-ifah-europe-info-day-10-11-march-2011" }, { "title": "European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/02/2011", "last_updated_date": "18/02/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reviews-further-data-narcolepsy-possible-association-pandemrix" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 February 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "18/02/2011", "last_updated_date": "18/02/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-february-2011" }, { "title": "First clinical biomarker qualification released for public consultation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/02/2011", "last_updated_date": "17/02/2011", "news_url": "https://www.ema.europa.eu/en/news/first-clinical-biomarker-qualification-released-public-consultation" }, { "title": "Merck Serono Europe Limited withdraws its marketing authorisation application for Movectro (cladribine)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/02/2011", "last_updated_date": "17/02/2011", "news_url": "https://www.ema.europa.eu/en/news/merck-serono-europe-limited-withdraws-its-marketing-authorisation-application-movectro-cladribine" }, { "title": "Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Topotecan SUN (topotecan)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/02/2011", "last_updated_date": "17/02/2011", "news_url": "https://www.ema.europa.eu/en/news/sun-pharmaceutical-industries-europe-bv-withdraws-its-marketing-authorisation-application-topotecan-sun-topotecan" }, { "title": "European Medicines Agency website updated with new searching and sharing features", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "16/02/2011", "last_updated_date": "16/02/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-website-updated-new-searching-sharing-features" }, { "title": "European Medicines Agency and Swissmedic extend confidentiality arrangement", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "14/02/2011", "last_updated_date": "14/02/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-swissmedic-extend-confidentiality-arrangement" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 8-10 February 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/02/2011", "last_updated_date": "11/02/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-february-2011" }, { "title": "Agency sets out work priorities for 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "11/02/2011", "last_updated_date": "11/02/2011", "news_url": "https://www.ema.europa.eu/en/news/agency-sets-out-work-priorities-2011" }, { "title": "European Medicines Agency hosts global animal health conference on availability of veterinary medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "09/02/2011", "last_updated_date": "09/02/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-hosts-global-animal-health-conference-availability-veterinary-medicines" }, { "title": "New version of EudraGMP allows access to information from all Member States", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "08/02/2011", "last_updated_date": "08/02/2011", "news_url": "https://www.ema.europa.eu/en/news/new-version-eudragmp-allows-access-information-all-member-states" }, { "title": "Agency releases new guidance on medicines based on stem cells", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "05/02/2011", "last_updated_date": "05/02/2011", "news_url": "https://www.ema.europa.eu/en/news/agency-releases-new-guidance-medicines-based-stem-cells" }, { "title": "Expressions of interest invited for transatlantic workshop on drug-related PML", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "05/02/2011", "last_updated_date": "05/02/2011", "news_url": "https://www.ema.europa.eu/en/news/expressions-interest-invited-transatlantic-workshop-drug-related-pml" }, { "title": "World Cancer Day: 4 February 2011", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/02/2011", "last_updated_date": "03/02/2011", "news_url": "https://www.ema.europa.eu/en/news/world-cancer-day-4-february-2011" }, { "title": "European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) adopts work plan for 2011-2012", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Pharmacovigilance", "news_summary": "", "first_published_date": "02/02/2011", "last_updated_date": "02/02/2011", "news_url": "https://www.ema.europa.eu/en/news/european-network-centres-pharmacoepidemiology-pharmacovigilance-encepp-adopts-work-plan-2011-2012" }, { "title": "Pre-accession linguistic check for Croatian underway", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "31/01/2011", "last_updated_date": "31/01/2011", "news_url": "https://www.ema.europa.eu/en/news/pre-accession-linguistic-check-croatian-underway" }, { "title": "European Medicines Agency publishes final 'Road map to 2015'", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/01/2011", "last_updated_date": "26/01/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-final-road-map-2015" }, { "title": "Benefit-risk review of Multaq started", "press_release": "No", "related_medicine_referral": "Multaq", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/01/2011", "last_updated_date": "21/01/2011", "news_url": "https://www.ema.europa.eu/en/news/benefit-risk-review-multaq-started" }, { "title": "Review of the manufacture of Baxter's peritoneal dialysis solutions initiated over potential presence of endotoxins in some batches", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/01/2011", "last_updated_date": "21/01/2011", "news_url": "https://www.ema.europa.eu/en/news/review-manufacture-baxters-peritoneal-dialysis-solutions-initiated-over-potential-presence-endotoxins-some-batches" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 January 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "21/01/2011", "last_updated_date": "21/01/2011", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-january-2011" }, { "title": "Report published on the uses of medicines for children in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Paediatrics", "news_summary": "", "first_published_date": "21/01/2011", "last_updated_date": "21/01/2011", "news_url": "https://www.ema.europa.eu/en/news/report-published-uses-medicines-children-european-union" }, { "title": "Launch of public consultation to start discussion on clinical studies of herbal medicines in children", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "Paediatrics", "news_summary": "", "first_published_date": "19/01/2011", "last_updated_date": "19/01/2011", "news_url": "https://www.ema.europa.eu/en/news/launch-public-consultation-start-discussion-clinical-studies-herbal-medicines-children" }, { "title": "Abbott Laboratories Limited withdraws its marketing authorisation application for Ozespa (briakinumab)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/01/2011", "last_updated_date": "17/01/2011", "news_url": "https://www.ema.europa.eu/en/news/abbott-laboratories-limited-withdraws-its-marketing-authorisation-application-ozespa-briakinumab" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 11-13 January 2011", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/01/2011", "last_updated_date": "14/01/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-january-2011" }, { "title": "ChemGenex Europe SAS withdraws its marketing authorisation application for Tekinex (omacetaxine mepesuccinate)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "12/01/2011", "last_updated_date": "12/01/2011", "news_url": "https://www.ema.europa.eu/en/news/chemgenex-europe-sas-withdraws-its-marketing-authorisation-application-tekinex-omacetaxine-mepesuccinate" }, { "title": "European Medicines Agency opens public discussion on need for active control in clinical trials", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "12/01/2011", "last_updated_date": "12/01/2011", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-opens-public-discussion-need-active-control-clinical-trials" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP) publishes new draft strategy on combating antimicrobial resistance", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/01/2011", "last_updated_date": "11/01/2011", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-publishes-new-draft-strategy-combating-antimicrobial-resistance" }, { "title": "New membership list published for the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "07/01/2011", "last_updated_date": "07/01/2011", "news_url": "https://www.ema.europa.eu/en/news/new-membership-list-published-european-network-paediatric-research-european-medicines-agency-enpr-ema" }, { "title": "European Medicines Agency and European Centre for Disease Prevention and Control agree to enhance co-operation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/12/2010", "last_updated_date": "22/12/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-centre-disease-prevention-control-agree-enhance-co-operation" }, { "title": "European Medicines Agency's Management Board endorses work programme 2011 and launches new Road Map to 2015", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-endorses-work-programme-2011-launches-new-road-map-2015" }, { "title": "European Medicines Agency facilitates interaction between small and medium-sized enterprises (SMEs)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;SME", "news_summary": "", "first_published_date": "21/12/2010", "last_updated_date": "21/12/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-facilitates-interaction-between-small-medium-sized-enterprises-smes" }, { "title": "European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/12/2010", "last_updated_date": "17/12/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-action-plan-deal-possible-presence-endotoxins-baxter-peritoneal-dialysis-solutions" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "17/12/2010", "last_updated_date": "17/12/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2010" }, { "title": "Veterinary post-authorisation guidance updated with new sections and questions", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/12/2010", "last_updated_date": "16/12/2010", "news_url": "https://www.ema.europa.eu/en/news/veterinary-post-authorisation-guidance-updated-new-sections-questions" }, { "title": "Update on somatropin-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/12/2010", "last_updated_date": "16/12/2010", "news_url": "https://www.ema.europa.eu/en/news/update-somatropin-containing-medicines" }, { "title": "Update on the withdrawal of Thelin", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/12/2010", "last_updated_date": "16/12/2010", "news_url": "https://www.ema.europa.eu/en/news/update-withdrawal-thelin" }, { "title": "European Medicines Agency completes its review of Avastin used in breast cancer", "press_release": "Yes", "related_medicine_referral": "Avastin", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/12/2010", "last_updated_date": "16/12/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-completes-its-review-avastin-used-breast-cancer" }, { "title": "Novartis Europharm Ltd. withdraws its application for an extension of indication for Zometa (zoledronic acid)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/12/2010", "last_updated_date": "15/12/2010", "news_url": "https://www.ema.europa.eu/en/news/novartis-europharm-ltd-withdraws-its-application-extension-indication-zometa-zoledronic-acid" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 7-9 December 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/12/2010", "last_updated_date": "10/12/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-december-2010" }, { "title": "Thelin (sitaxentan) to be withdrawn due to cases of unpredictable serious liver injury", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "10/12/2010", "last_updated_date": "10/12/2010", "news_url": "https://www.ema.europa.eu/en/news/thelin-sitaxentan-be-withdrawn-due-cases-unpredictable-serious-liver-injury" }, { "title": "European Medicines Agency to review the safety of somatropin-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "10/12/2010", "last_updated_date": "10/12/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-review-safety-somatropin-containing-medicines" }, { "title": "Sanofi Pasteur withdraws its marketing authorisation application for Emerflu, pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/12/2010", "last_updated_date": "06/12/2010", "news_url": "https://www.ema.europa.eu/en/news/sanofi-pasteur-withdraws-its-marketing-authorisation-application-emerflu-pandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted" }, { "title": "World AIDS Day: 1 December 2010", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "30/11/2010", "last_updated_date": "30/11/2010", "news_url": "https://www.ema.europa.eu/en/news/world-aids-day-1-december-2010" }, { "title": "European Medicines Agency widens public access to documents", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "30/11/2010", "last_updated_date": "30/11/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-widens-public-access-documents" }, { "title": "Draft guideline on biosimilar medicines containing monoclonal antibodies released for consultation", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Biosimilars;Regulatory and procedural guidance", "news_summary": "", "first_published_date": "26/11/2010", "last_updated_date": "26/11/2010", "news_url": "https://www.ema.europa.eu/en/news/draft-guideline-biosimilar-medicines-containing-monoclonal-antibodies-released-consultation" }, { "title": "European Medicines Agency and European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) launch electronic Register of Studies (E-Register)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "25/11/2010", "last_updated_date": "25/11/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-network-centres-pharmacoepidemiology-pharmacovigilance-encepp-launch-electronic-register-studies-e-register" }, { "title": "Committee on Herbal Medicinal Products elects new chair and vice-chair", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal;Herbal", "topics": "", "news_summary": "", "first_published_date": "24/11/2010", "last_updated_date": "24/11/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-herbal-medicinal-products-elects-new-chair-vice-chair" }, { "title": "Agency internal and external IT systems offline from 26 November 1800 UK time to 29 November 0900 UK time", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/11/2010", "last_updated_date": "23/11/2010", "news_url": "https://www.ema.europa.eu/en/news/agency-internal-external-it-systems-offline-26-november-1800-uk-time-29-november-0900-uk-time" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 November 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "19/11/2010", "last_updated_date": "19/11/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-november-2010" }, { "title": "European Medicines Agency confirms that presence of unexpected viral DNA in live attenuated vaccines does not raise public health concerns", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/11/2010", "last_updated_date": "18/11/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-presence-unexpected-viral-dna-live-attenuated-vaccines-does-not-raise-public-health-concerns" }, { "title": "The number of tests required to control for complete inactivation in inactivated vaccines", "press_release": "No", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/11/2010", "last_updated_date": "18/11/2010", "news_url": "https://www.ema.europa.eu/en/news/number-tests-required-control-complete-inactivation-inactivated-vaccines" }, { "title": "Committee for Advanced Therapies adopts five-year work programme to foster development of advanced therapies", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "18/11/2010", "last_updated_date": "18/11/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-adopts-five-year-work-programme-foster-development-advanced-therapies" }, { "title": "European Antibiotic Awareness Day: 18 November 2010", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/11/2010", "last_updated_date": "17/11/2010", "news_url": "https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-18-november-2010" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 9-11 November 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/11/2010", "last_updated_date": "12/11/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-november-2010" }, { "title": "European Medicines Agency and Massachusetts Institute of Technology launch joint project on regulatory science", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "11/11/2010", "last_updated_date": "11/11/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-massachusetts-institute-technology-launch-joint-project-regulatory-science" }, { "title": "Report on origins of clinical trial participants updated", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "10/11/2010", "last_updated_date": "10/11/2010", "news_url": "https://www.ema.europa.eu/en/news/report-origins-clinical-trial-participants-updated" }, { "title": "Schering-Plough Europe withdraws its marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "09/11/2010", "last_updated_date": "09/11/2010", "news_url": "https://www.ema.europa.eu/en/news/schering-plough-europe-withdraws-its-marketing-authorisation-application-zenhale-mometasone-furoate-formoterol-fumarate" }, { "title": "ENCePP releases for public consultation draft Guide on Methodological Standards in Pharmacoepidemiology", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/11/2010", "last_updated_date": "08/11/2010", "news_url": "https://www.ema.europa.eu/en/news/encepp-releases-public-consultation-draft-guide-methodological-standards-pharmacoepidemiology" }, { "title": "Recruitment procedure for new Executive Director of the European Medicines Agency started", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "03/11/2010", "last_updated_date": "03/11/2010", "news_url": "https://www.ema.europa.eu/en/news/recruitment-procedure-new-executive-director-european-medicines-agency-started" }, { "title": "CHMP working parties reorganised", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/10/2010", "last_updated_date": "25/10/2010", "news_url": "https://www.ema.europa.eu/en/news/chmp-working-parties-reorganised" }, { "title": "Pilots of multi-stakeholder consultations in early-stage drug development", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/10/2010", "last_updated_date": "25/10/2010", "news_url": "https://www.ema.europa.eu/en/news/pilots-multi-stakeholder-consultations-early-stage-drug-development" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 18-21 October 2010", "press_release": "Yes", "related_medicine_referral": "Invirase", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "22/10/2010", "last_updated_date": "22/10/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-october-2010" }, { "title": "European Medicines Agency reviews treatment recommendations for Fabrazyme", "press_release": "Yes", "related_medicine_referral": "Fabrazyme", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/10/2010", "last_updated_date": "22/10/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reviews-treatment-recommendations-fabrazyme" }, { "title": "European Medicines Agency recommends use of fibrates as second-line treatment", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/10/2010", "last_updated_date": "22/10/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-use-fibrates-second-line-treatment" }, { "title": "European Medicines Agency concludes that benefit-risk balance of Invirase remains positive", "press_release": "Yes", "related_medicine_referral": "Invirase", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/10/2010", "last_updated_date": "21/10/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-benefit-risk-balance-invirase-remains-positive" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 12-13 October 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/10/2010", "last_updated_date": "15/10/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-12-13-october-2010" }, { "title": "European Medicines Agency strengthens rules on conflicts of interests of its scientific experts", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "14/10/2010", "last_updated_date": "14/10/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-strengthens-rules-conflicts-interests-its-scientific-experts" }, { "title": "New fees for marketing authorisation applications in force", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "13/10/2010", "last_updated_date": "13/10/2010", "news_url": "https://www.ema.europa.eu/en/news/new-fees-marketing-authorisation-applications-force" }, { "title": "European Medicines Agency publishes second work package of benefit-risk methodology project", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "13/10/2010", "last_updated_date": "13/10/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-second-work-package-benefit-risk-methodology-project" }, { "title": "European Medicines Agency Management Board adopt new policies on handling of conflicts of interests and on access to documents", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/10/2010", "last_updated_date": "08/10/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-management-board-adopt-new-policies-handling-conflicts-interests-access-documents" }, { "title": "European Medicines Agency receives 1,000th application for a Paediatric Investigation Plan or Waiver", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "08/10/2010", "last_updated_date": "08/10/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-receives-1000th-application-paediatric-investigation-plan-or-waiver" }, { "title": "European Medicines Agency awards first 'ENCePP study' seal for post-marketing study", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "01/10/2010", "last_updated_date": "01/10/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-awards-first-encepp-study-seal-post-marketing-study" }, { "title": "Warner Chilcott UK Ltd withdraws its application for an extension of indication for Intrinsa", "press_release": "Yes", "related_medicine_referral": "Intrinsa", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/09/2010", "last_updated_date": "29/09/2010", "news_url": "https://www.ema.europa.eu/en/news/warner-chilcott-uk-ltd-withdraws-its-application-extension-indication-intrinsa" }, { "title": "European Medicines Agency recommends suspension of Octagam in all EU Member States", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/09/2010", "last_updated_date": "24/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-octagam-all-eu-member-states" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 20-23 September 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "24/09/2010", "last_updated_date": "24/09/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-september-2010" }, { "title": "European Medicines Agency confirms positive benefit-risk balance of RotaTeq", "press_release": "Yes", "related_medicine_referral": "RotaTeq", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2010", "last_updated_date": "23/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-rotateq" }, { "title": "European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2010", "last_updated_date": "23/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-review-pandemrix-reports-narcolepsy" }, { "title": "European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/09/2010", "last_updated_date": "23/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-avandia-avandamet-avaglim" }, { "title": "European Medicines Agency welcomes adoption of new pharmacovigilance legislation by European Parliament", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/09/2010", "last_updated_date": "22/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-adoption-new-pharmacovigilance-legislation-european-parliament" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 14-16 September 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/09/2010", "last_updated_date": "20/09/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-september-2010" }, { "title": "European Medicines Agency publishes first review of orphan designation", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Rare diseases", "news_summary": "", "first_published_date": "17/09/2010", "last_updated_date": "17/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-first-review-orphan-designation" }, { "title": "Novartis Europharm Ltd withdraws its marketing authorisation application for Rasival (aliskiren/valsartan)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/09/2010", "last_updated_date": "17/09/2010", "news_url": "https://www.ema.europa.eu/en/news/novartis-europharm-ltd-withdraws-its-marketing-authorisation-application-rasival-aliskiren-valsartan" }, { "title": "European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements indefinitely", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "15/09/2010", "last_updated_date": "15/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-extend-confidentiality-arrangements-indefinitely" }, { "title": "European Medicines Agency holds international workshop on clinical trials in the context of global medicines development", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "09/09/2010", "last_updated_date": "09/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-holds-international-workshop-clinical-trials-context-global-medicines-development" }, { "title": "CHMP meets to discuss Avandia and Pandemrix", "press_release": "No", "related_medicine_referral": "Pandemrix", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "08/09/2010", "last_updated_date": "08/09/2010", "news_url": "https://www.ema.europa.eu/en/news/chmp-meets-discuss-avandia-pandemrix" }, { "title": "Patients' and Consumers' Working Party elects new co-chair", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/09/2010", "last_updated_date": "08/09/2010", "news_url": "https://www.ema.europa.eu/en/news/patients-consumers-working-party-elects-new-co-chair" }, { "title": "European Medicines Agency holds first scientific workshop on nanomedicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "06/09/2010", "last_updated_date": "06/09/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-holds-first-scientific-workshop-nanomedicines" }, { "title": "CHMP meeting on 8 September 2010 to discuss Avandia and Pandemrix", "press_release": "No", "related_medicine_referral": "Pandemrix", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "03/09/2010", "last_updated_date": "03/09/2010", "news_url": "https://www.ema.europa.eu/en/news/chmp-meeting-8-september-2010-discuss-avandia-pandemrix" }, { "title": "European Medicines Agency starts review of Pandemrix", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/08/2010", "last_updated_date": "27/08/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-review-pandemrix" }, { "title": "European Medicines Agency and United States Food and Drug Administration seek potential candidate companies for joint good-manufacturing-practice inspection programme", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "11/08/2010", "last_updated_date": "11/08/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-united-states-food-drug-administration-seek-potential-candidate-companies-joint-good-manufacturing-practice-inspection-programme" }, { "title": "Are you an SME interested in funding of Adverse Drug Reaction research through the European Commission's 7th Framework Programme?", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "SME", "news_summary": "", "first_published_date": "27/07/2010", "last_updated_date": "27/07/2010", "news_url": "https://www.ema.europa.eu/en/news/are-you-sme-interested-funding-adverse-drug-reaction-research-through-european-commissions-7th-framework-programme" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "23/07/2010", "last_updated_date": "23/07/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-july-2010" }, { "title": "European Medicines Agency concludes review of modified-release oral opioids of the WHO level III scale for the management of pain", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/07/2010", "last_updated_date": "23/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-review-modified-release-oral-opioids-who-level-iii-scale-management-pain" }, { "title": "European Medicines Agency recommends restricting the use of modafinil", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/07/2010", "last_updated_date": "22/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-modafinil" }, { "title": "European Medicines Agency confirms positive benefit-risk balance of topical formulations of ketoprofen", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/07/2010", "last_updated_date": "22/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-topical-formulations-ketoprofen" }, { "title": "European Medicines Agency confirms positive benefit-risk balance of Rotarix", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/07/2010", "last_updated_date": "22/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-rotarix" }, { "title": "European Medicines Agency update on ongoing benefit-risk review of Avandia, Avandamet and Avaglim", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/07/2010", "last_updated_date": "22/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-ongoing-benefit-risk-review-avandia-avandamet-avaglim" }, { "title": "European Medicines Agency publishes policy on communicating safety issues for human medicines", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/07/2010", "last_updated_date": "20/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-policy-communicating-safety-issues-human-medicines" }, { "title": "Reminder to applicants regarding requirements for all future eCTD submissions", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/07/2010", "last_updated_date": "19/07/2010", "news_url": "https://www.ema.europa.eu/en/news/reminder-applicants-regarding-requirements-all-future-ectd-submissions" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 13-15 July 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/07/2010", "last_updated_date": "16/07/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-july-2010" }, { "title": "European Medicines Agency launches new website", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "16/07/2010", "last_updated_date": "16/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-new-website" }, { "title": "European Medicines Agency starts review of rosiglitazone-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "09/07/2010", "last_updated_date": "09/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-starts-review-rosiglitazone-containing-medicines" }, { "title": "European Medicines Agency and European Commission start reflection process on way forward for the Agency and the network", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "08/07/2010", "last_updated_date": "08/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-commission-start-reflection-process-way-forward-agency-network" }, { "title": "European Medicines Agency updates treatment recommendations because of continued Fabrazyme shortage", "press_release": "Yes", "related_medicine_referral": "Fabrazyme", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "06/07/2010", "last_updated_date": "06/07/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-treatment-recommendations-because-continued-fabrazyme-shortage" }, { "title": "CHMP re-elects its Chair and Vice-Chair", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/07/2010", "last_updated_date": "02/07/2010", "news_url": "https://www.ema.europa.eu/en/news/chmp-re-elects-its-chair-vice-chair" }, { "title": "SME Office wins award for 'Most significant contribution to mediscience sector'", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "SME", "news_summary": "", "first_published_date": "26/06/2010", "last_updated_date": "26/06/2010", "news_url": "https://www.ema.europa.eu/en/news/sme-office-wins-award-most-significant-contribution-mediscience-sector" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 21-24 June 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "25/06/2010", "last_updated_date": "25/06/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-june-2010" }, { "title": "Call for expression of interest for health professional and patient organisations representatives for the Paediatric Committee (PDCO) launched", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Paediatrics", "news_summary": "", "first_published_date": "25/06/2010", "last_updated_date": "25/06/2010", "news_url": "https://www.ema.europa.eu/en/news/call-expression-interest-health-professional-patient-organisations-representatives-paediatric-committee-pdco-launched" }, { "title": "European Medicines Agency Management Board re-elects Pat O'Mahony as chair", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "18/06/2010", "last_updated_date": "18/06/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-management-board-re-elects-pat-omahony-chair" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 15-17 June 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/06/2010", "last_updated_date": "18/06/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-15-17-june-2010" }, { "title": "European Medicines Agency and European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) sign cooperation agreement", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "15/06/2010", "last_updated_date": "15/06/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-monitoring-centre-drugs-drug-addiction-emcdda-sign-cooperation-agreement" }, { "title": "European Medicines Agency and European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launch 'ENCePP studies'", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Pharmacovigilance", "news_summary": "", "first_published_date": "11/06/2010", "last_updated_date": "11/06/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-network-centres-pharmacoepidemiology-pharmacovigilance-encepp-launch-encepp-studies" }, { "title": "European Medicines Agency launches public consultation on ethical and good clinical practice (GCP) aspects of clinical trials conducted in third countries", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "28/05/2010", "last_updated_date": "28/05/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-public-consultation-ethical-good-clinical-practice-gcp-aspects-clinical-trials-conducted-third-countries" }, { "title": "Wyeth Europa Limited withdraws its marketing authorisation application for Brilence", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/05/2010", "last_updated_date": "28/05/2010", "news_url": "https://www.ema.europa.eu/en/news/wyeth-europa-limited-withdraws-its-marketing-authorisation-application-brilence" }, { "title": "Committee for Advanced Therapies gives first certification opinion for advanced therapies medicinal product", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "26/05/2010", "last_updated_date": "26/05/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-gives-first-certification-opinion-advanced-therapies-medicinal-product" }, { "title": "EudraVigilance signal detection methods help detect drug safety issues earlier", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/05/2010", "last_updated_date": "25/05/2010", "news_url": "https://www.ema.europa.eu/en/news/eudravigilance-signal-detection-methods-help-detect-drug-safety-issues-earlier" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 17-20 May 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "21/05/2010", "last_updated_date": "21/05/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-may-2010" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 18-20 May 2010", "press_release": "Yes", "related_medicine_referral": "Ingelvac CircoFLEX;Cortavance;Masivet;Ypozane;Slentrol;Rheumocam;Reconcile;Spironolactone Ceva;Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli);Porcilis PCV;Oxyglobin;Palladia;Naxcel;Melovem;Gonazon;Previcox;Equioxx;Cerenia;Equilis Prequenza;Equilis Prequenza Te;Equilis Te", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "21/05/2010", "last_updated_date": "21/05/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-18-20-may-2010" }, { "title": "Ten years of orphan medicines legislation in Europe – European Medicines Agency reviews success and looks ahead", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/05/2010", "last_updated_date": "20/05/2010", "news_url": "https://www.ema.europa.eu/en/news/ten-years-orphan-medicines-legislation-europe-european-medicines-agency-reviews-success-looks-ahead" }, { "title": "Annual report 2009 published: \"Agency achieved very good results in one of the most challenging years in its history\"", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/05/2010", "last_updated_date": "20/05/2010", "news_url": "https://www.ema.europa.eu/en/news/annual-report-2009-published-agency-achieved-very-good-results-one-most-challenging-years-its-history" }, { "title": "European and international experts discuss the way forward in stem-cell research and development", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "12/05/2010", "last_updated_date": "12/05/2010", "news_url": "https://www.ema.europa.eu/en/news/european-international-experts-discuss-way-forward-stem-cell-research-development" }, { "title": "European paediatric research network ready to start", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "12/05/2010", "last_updated_date": "12/05/2010", "news_url": "https://www.ema.europa.eu/en/news/european-paediatric-research-network-ready-start" }, { "title": "European Medicines Agency gives new temporary treatment recommendations for Fabrazyme", "press_release": "Yes", "related_medicine_referral": "Cerezyme;Fabrazyme", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/04/2010", "last_updated_date": "23/04/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-new-temporary-treatment-recommendations-fabrazyme" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 19-22 April 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "23/04/2010", "last_updated_date": "23/04/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-april-2010" }, { "title": "European Medicines Agency recommends revocation of marketing authorisations for bufexamac", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/04/2010", "last_updated_date": "22/04/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-revocation-marketing-authorisations-bufexamac" }, { "title": "Novartis Europharm Ltd withdraws its marketing authorisation application for Joulferon (albinterferon alfa-2b)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/04/2010", "last_updated_date": "19/04/2010", "news_url": "https://www.ema.europa.eu/en/news/novartis-europharm-ltd-withdraws-its-marketing-authorisation-application-joulferon-albinterferon-alfa-2b" }, { "title": "Public statement on concerns over unregulated medicinal products containing stem cells", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "16/04/2010", "last_updated_date": "16/04/2010", "news_url": "https://www.ema.europa.eu/en/news/public-statement-concerns-over-unregulated-medicinal-products-containing-stem-cells" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 13-15 April 2010", "press_release": "Yes", "related_medicine_referral": "BTVPUR Alsap 8;Metacam;Onsior;Easotic;Masivet;Palladia;BTVPUR Alsap 8;Suprelorin;Profender;Naxcel;Draxxin;SevoFlo;Virbagen Omega", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/04/2010", "last_updated_date": "16/04/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-april-2010" }, { "title": "European Medicines Agency sees no safety concerns with the Rotarix oral vaccine", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/03/2010", "last_updated_date": "26/03/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-sees-no-safety-concerns-rotarix-oral-vaccine" }, { "title": "European Medicines Agency's Management Board emphasises the importance of the European medicines network", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/03/2010", "last_updated_date": "26/03/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-emphasises-importance-european-medicines-network" }, { "title": "European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "25/03/2010", "last_updated_date": "25/03/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-precautionary-recall-batches-clopidogrel-containing-medicines-acino-pharma-gmbh" }, { "title": "Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Repaglinide SUN (repaglinide)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/03/2010", "last_updated_date": "25/03/2010", "news_url": "https://www.ema.europa.eu/en/news/sun-pharmaceutical-industries-europe-bv-withdraws-its-marketing-authorisation-application-repaglinide-sun-repaglinide" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 March 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "19/03/2010", "last_updated_date": "19/03/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-march-2010" }, { "title": "European Medicines Agency statement on new information on Rotarix oral vaccine", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/03/2010", "last_updated_date": "19/03/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-new-information-rotarix-oral-vaccine" }, { "title": "Public statement on interaction between clopidogrel and proton-pump inhibitors", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/03/2010", "last_updated_date": "17/03/2010", "news_url": "https://www.ema.europa.eu/en/news/public-statement-interaction-between-clopidogrel-proton-pump-inhibitors" }, { "title": "Mylan S.A.S. withdraws its marketing authorisation application for Docetaxel Mylan (docetaxel)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/03/2010", "last_updated_date": "15/03/2010", "news_url": "https://www.ema.europa.eu/en/news/mylan-sas-withdraws-its-marketing-authorisation-application-docetaxel-mylan-docetaxel" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 9-11 March 2010", "press_release": "Yes", "related_medicine_referral": "Improvac;Vaxxitek HVT+IBD;Nobilis Influenza H7N1;Nobilis Influenza H5N2;Equip WNV (previously Duvaxyn WNV);Ibaflin;Naxcel", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/03/2010", "last_updated_date": "12/03/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-march-2010" }, { "title": "Ark Therapeutics Ltd withdraws its marketing authorisation application for Cerepro (sitimagene ceradenovec)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "11/03/2010", "last_updated_date": "11/03/2010", "news_url": "https://www.ema.europa.eu/en/news/ark-therapeutics-ltd-withdraws-its-marketing-authorisation-application-cerepro-sitimagene-ceradenovec" }, { "title": "Food and Drug Administration and European Medicines Agency agree to accept a single orphan drug designation annual report", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/02/2010", "last_updated_date": "26/02/2010", "news_url": "https://www.ema.europa.eu/en/news/food-drug-administration-european-medicines-agency-agree-accept-single-orphan-drug-designation-annual-report" }, { "title": "United Therapeutics Europe Ltd withdraws its marketing authorisation application for Tyvaso", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/02/2010", "last_updated_date": "19/02/2010", "news_url": "https://www.ema.europa.eu/en/news/united-therapeutics-europe-ltd-withdraws-its-marketing-authorisation-application-tyvaso" }, { "title": "European Medicines Agency updates on pandemic influenza", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/02/2010", "last_updated_date": "19/02/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-pandemic-influenza" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 February 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "19/02/2010", "last_updated_date": "19/02/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-february-2010" }, { "title": "European Medicines Agency recommends contraindication for Regranex in patients with any pre-existing cancer", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/02/2010", "last_updated_date": "18/02/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-contraindication-regranex-patients-any-pre-existing-cancer" }, { "title": "European Medicines Agency and EUnetHTA Joint Action start collaboration on European Public Assessment Report (EPAR) contribution to relative effectiveness assessments", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "16/02/2010", "last_updated_date": "16/02/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-eunethta-joint-action-start-collaboration-european-public-assessment-report-epar-contribution-relative-effectiveness-assessments" }, { "title": "European Medicines Agency and Swissmedic agree sharing of information on H1N1 pandemic medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "15/02/2010", "last_updated_date": "15/02/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-swissmedic-agree-sharing-information-h1n1-pandemic-medicines" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 9-11 February 2010", "press_release": "Yes", "related_medicine_referral": "BTVPUR Alsap 8;Suvaxyn PCV;Loxicom;Trocoxil;Meloxivet;Circovac;Aivlosin;Naxcel;Draxxin;ProteqFlu-Te;Rabigen SAG2", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/02/2010", "last_updated_date": "12/02/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-february-2010" }, { "title": "Meeting highlights from the Paediatric Committee: 27-29 May 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "03/06/2009", "last_updated_date": "11/02/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-27-29-may-2009" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP): 14-17 December 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "18/12/2009", "last_updated_date": "11/02/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-december-2009" }, { "title": "European Medicines Agency updates on ongoing safety review of sibutramine: Weight-loss medicine assessed over cardiovascular concerns", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/12/2009", "last_updated_date": "11/02/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-ongoing-safety-review-sibutramine-weight-loss-medicine-assessed-over-cardiovascular-concerns" }, { "title": "European Medicines Agency 2009 mid-year report shows it is still on target, despite influenza pandemic activities", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "26/10/2009", "last_updated_date": "11/02/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-2009-mid-year-report-shows-it-still-target-despite-influenza-pandemic-activities" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 18-21 January 2010", "press_release": "Yes", "related_medicine_referral": "Tysabri", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "28/01/2010", "last_updated_date": "28/01/2010", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-january-2010" }, { "title": "Committee on Advanced Therapies (CAT) celebrates its first birthday", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "27/01/2010", "last_updated_date": "27/01/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-cat-celebrates-its-first-birthday" }, { "title": "European Medicines Agency launches consultation on its Road Map to 2015", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/01/2010", "last_updated_date": "26/01/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-consultation-its-road-map-2015" }, { "title": "European Medicines Agency recommends suspension of marketing authorisation for sibutramine", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/01/2010", "last_updated_date": "22/01/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisation-sibutramine" }, { "title": "European Medicines Agency gives first opinion on compassionate use", "press_release": "Yes", "related_medicine_referral": "Tamiflu", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/01/2010", "last_updated_date": "22/01/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-first-opinion-compassionate-use" }, { "title": "European Medicines Agency updates on pandemic influenza", "press_release": "Yes", "related_medicine_referral": "Tamiflu;Pandemrix", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/01/2010", "last_updated_date": "22/01/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-pandemic-influenza-0" }, { "title": "European Medicines Agency recommends additional measures to better manage risk of progressive multifocal leukoencephalopathy (PML) with Tysabri", "press_release": "Yes", "related_medicine_referral": "Tysabri", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "21/01/2010", "last_updated_date": "21/01/2010", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-additional-measures-better-manage-risk-progressive-multifocal-leukoencephalopathy-pml-tysabri" }, { "title": "Janssen-Cilag International NV withdraws its marketing authorisation application for Comfyde (carisbamate)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/01/2010", "last_updated_date": "20/01/2010", "news_url": "https://www.ema.europa.eu/en/news/janssen-cilag-international-nv-withdraws-its-marketing-authorisation-application-comfyde-carisbamate" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 12-14 January 2010", "press_release": "Yes", "related_medicine_referral": "Meloxidyl;Improvac;Profender;Ingelvac CircoFLEX;Cerenia;Prac-tic;Nobilis Influenza H7N1;Nobilis Influenza H5N2;Purevax FeLV;Previcox;Ingelvac CircoFLEX", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/01/2010", "last_updated_date": "15/01/2010", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-12-14-january-2010" }, { "title": "Wyeth Consumer Healthcare withdraws its marketing authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "13/01/2010", "last_updated_date": "13/01/2010", "news_url": "https://www.ema.europa.eu/en/news/wyeth-consumer-healthcare-withdraws-its-marketing-authorisation-application-ibuprofen-diphenhydramine-hydrochloride-wyeth" }, { "title": "Sanofi Aventis withdraws its marketing authorisation application for Sliwens (eplivanserin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/12/2009", "last_updated_date": "21/12/2009", "news_url": "https://www.ema.europa.eu/en/news/sanofi-aventis-withdraws-its-marketing-authorisation-application-sliwens-eplivanserin" }, { "title": "European Medicines Agency recommends withdrawal of benfluorex from the market in European Union", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/12/2009", "last_updated_date": "18/12/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-withdrawal-benfluorex-market-european-union" }, { "title": "European Medicines Agency updates on pandemic medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/12/2009", "last_updated_date": "18/12/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-updates-pandemic-medicines" }, { "title": "Meeting highlights from the Paediatric Committee: 09 -11 December 2009", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "17/12/2009", "last_updated_date": "17/12/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-09-11-december-2009" }, { "title": "European Medicines Agency's Management Board endorses the work programme 2010 and strengthens the involvement of patients in the work of the Agency", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/12/2009", "last_updated_date": "17/12/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-endorses-work-programme-2010-strengthens-involvement-patients-work-agency" }, { "title": "Bayer Schering Pharma withdraws its marketing authorisation application for Recothrom (thrombin alfa)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/12/2009", "last_updated_date": "14/12/2009", "news_url": "https://www.ema.europa.eu/en/news/bayer-schering-pharma-withdraws-its-marketing-authorisation-application-recothrom-thrombin-alfa" }, { "title": "European Medicines Agency takes a further step in its interaction with patients and consumers", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "12/12/2009", "last_updated_date": "12/12/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-takes-further-step-its-interaction-patients-consumers" }, { "title": "Committee for Medicinal Products for Veterinary Use: Meeting of 8-10 December 2009", "press_release": "Yes", "related_medicine_referral": "Previcox;BTVPUR Alsap 8;BTVPUR Alsap 8;Equioxx;Loxicom;Cortavance;Porcilis PCV;Reconcile;Zactran;Medicinal Oxygen Air Liquide Sante;Rheumocam;Slentrol;Suprelorin;Equilis Te;Convenia;Profender;Previcox;Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli);Bovalto Ibraxion;Incurin;Rabigen SAG2;Metacam", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/12/2009", "last_updated_date": "11/12/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-8-10-december-2009" }, { "title": "Amarin Neuroscience Ltd withdraws its marketing authorisation application for Ethyl Eicosapent Soft Capsules (ethyl eicosapent)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/12/2009", "last_updated_date": "08/12/2009", "news_url": "https://www.ema.europa.eu/en/news/amarin-neuroscience-ltd-withdraws-its-marketing-authorisation-application-ethyl-eicosapent-soft-capsules-ethyl-eicosapent" }, { "title": "European Medicines Agency launches new organisational structure and new visual identity", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "08/12/2009", "last_updated_date": "08/12/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-new-organisational-structure-new-visual-identity" }, { "title": "European Medicines Agency advises of risk of fever in young children following vaccination with Pandemrix", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "04/12/2009", "last_updated_date": "04/12/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-advises-risk-fever-young-children-following-vaccination-pandemrix" }, { "title": "European Medicines Agency publishes first weekly pandemic pharmacovigilance update", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "03/12/2009", "last_updated_date": "03/12/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-first-weekly-pandemic-pharmacovigilance-update" }, { "title": "Axxonis Pharma AG withdraws its marketing authorisation application for Nenad (lisuride)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/12/2009", "last_updated_date": "03/12/2009", "news_url": "https://www.ema.europa.eu/en/news/axxonis-pharma-ag-withdraws-its-marketing-authorisation-application-nenad-lisuride" }, { "title": "Antigenics Therapeutics Limited withdraws its marketing authorisation application for Oncophage (vitespen)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/11/2009", "last_updated_date": "02/12/2009", "news_url": "https://www.ema.europa.eu/en/news/antigenics-therapeutics-limited-withdraws-its-marketing-authorisation-application-oncophage-vitespen" }, { "title": "European Medicines Agency recommends authorisation of two additional Bluetongue vaccines through the centralised procedure", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/11/2009", "last_updated_date": "27/11/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-two-additional-bluetongue-vaccines-through-centralised-procedure" }, { "title": "Meeting highlights from the Paediatric Committee: 11 - 13 November 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "24/11/2009", "last_updated_date": "24/11/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-11-13-november-2009" }, { "title": "European Medicines Agency reaffirms efficacy and safety of H1N1 pandemic vaccines", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/11/2009", "last_updated_date": "20/11/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-reaffirms-efficacy-safety-h1n1-pandemic-vaccines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 16-19 November 2009", "press_release": "Yes", "related_medicine_referral": "Erbitux;Avastin;Thyrogen;Pandemrix", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "20/11/2009", "last_updated_date": "20/11/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-november-2009" }, { "title": "European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/11/2009", "last_updated_date": "20/11/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-makes-recommendations-minimise-risk-nephrogenic-systemic-fibrosis-gadolinium-containing-contrast-agents-0" }, { "title": "Otsuka Pharmaceutical Europe Ltd withdraws its application for an extension of indication for Abilify (aripiprazole)", "press_release": "Yes", "related_medicine_referral": "Abilify", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/11/2009", "last_updated_date": "19/11/2009", "news_url": "https://www.ema.europa.eu/en/news/otsuka-pharmaceutical-europe-ltd-withdraws-its-application-extension-indication-abilify-aripiprazole" }, { "title": "Better surveillance needed to fight spread of antimicrobial resistance in zoonotic infections", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "16/11/2009", "last_updated_date": "16/11/2009", "news_url": "https://www.ema.europa.eu/en/news/better-surveillance-needed-fight-spread-antimicrobial-resistance-zoonotic-infections" }, { "title": "Committee for Medicinal Products for Veterinary Use: Meeting of 10-12 November 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/11/2009", "last_updated_date": "13/11/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-10-12-november-2009" }, { "title": "AstraZeneca: Withdraws its marketing authorisation application for Zactima (vandetanib)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "30/10/2009", "last_updated_date": "30/10/2009", "news_url": "https://www.ema.europa.eu/en/news/astrazeneca-withdraws-its-marketing-authorisation-application-zactima-vandetanib" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 October 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2009", "last_updated_date": "23/10/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use19-22-october-2009" }, { "title": "Arpida A/S withdraws its marketing authorisation application for Mersarex (iclaprim)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/10/2009", "last_updated_date": "23/10/2009", "news_url": "https://www.ema.europa.eu/en/news/arpida-s-withdraws-its-marketing-authorisation-application-mersarex-iclaprim" }, { "title": "Updated temporary treatment recommendations for Cerezyme", "press_release": "Yes", "related_medicine_referral": "Cerezyme", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "news_url": "https://www.ema.europa.eu/en/news/updated-temporary-treatment-recommendations-cerezyme" }, { "title": "Meeting highlights from the Paediatric Committee :14 -16 October 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "22/10/2009", "last_updated_date": "22/10/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-14-16-october-2009" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 13-15 October 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/10/2009", "last_updated_date": "16/10/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-13-15-october-2009" }, { "title": "GlaxoSmithKline withdraws its marketing authorisation application for Zunrisa (casopitant mesilate)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "13/10/2009", "last_updated_date": "13/10/2009", "news_url": "https://www.ema.europa.eu/en/news/glaxosmithkline-withdraws-its-marketing-authorisation-application-zunrisa-casopitant-mesilate" }, { "title": "European Medicines Agency implements internal reorganisation", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "05/10/2009", "last_updated_date": "05/10/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-implements-internal-reorganisation" }, { "title": "European Medicines Agency recommends authorisation of additional vaccine for influenza pandemic (H1N1) 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "02/10/2009", "last_updated_date": "02/10/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-additional-vaccine-influenza-pandemic-h1n1-2009" }, { "title": "European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009", "press_release": "Yes", "related_medicine_referral": "Pandemrix", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "25/09/2009", "last_updated_date": "25/09/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-two-vaccines-influenza-pandemic-h1n1-2009" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 September 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "25/09/2009", "last_updated_date": "25/09/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use21-24-september-2009" }, { "title": "Supply shortage of Fabrazyme – updated treatment recommendations required for adult male patients", "press_release": "Yes", "related_medicine_referral": "Fabrazyme", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/09/2009", "last_updated_date": "25/09/2009", "news_url": "https://www.ema.europa.eu/en/news/supply-shortage-fabrazyme-updated-treatment-recommendations-required-adult-male-patients" }, { "title": "Meeting highlights from the Paediatric Committee: 16 - 18 September 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "24/09/2009", "last_updated_date": "24/09/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-16-18-september-2009" }, { "title": "CTI Life Sciences Ltd. withdraws its marketing authorisation application for Opaxio (paclitaxel poliglumex)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/09/2009", "last_updated_date": "23/09/2009", "news_url": "https://www.ema.europa.eu/en/news/cti-life-sciences-ltd-withdraws-its-marketing-authorisation-application-opaxio-paclitaxel-poliglumex" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 15-17 September 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/09/2009", "last_updated_date": "18/09/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-15-17-september-2009" }, { "title": "The bacterial challenge - Time to react a call to narrow the gap between multidrug-resistant bacteria in the EU and development of new antibacterial agents", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/09/2009", "last_updated_date": "17/09/2009", "news_url": "https://www.ema.europa.eu/en/news/bacterial-challenge-time-react-call-narrow-gap-between-multidrug-resistant-bacteria-eu-development-new-antibacterial-agents" }, { "title": "Sanofi-Aventis withdraws marketing authorisation application for MULTAQ", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/09/2009", "last_updated_date": "08/09/2009", "news_url": "https://www.ema.europa.eu/en/news/sanofi-aventis-withdraws-marketing-authorisation-application-multaq" }, { "title": "Meeting highlights from the Paediatric Committee held by written procedure: 19 - 21 August 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "25/08/2009", "last_updated_date": "25/08/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-held-written-procedure-19-21-august-2009" }, { "title": "Targanta Netherlands B.V. withdraws its marketing authorisation application for Ramvocid (oritavancin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/08/2009", "last_updated_date": "24/08/2009", "news_url": "https://www.ema.europa.eu/en/news/targanta-netherlands-bv-withdraws-its-marketing-authorisation-application-ramvocid-oritavancin" }, { "title": "Supply shortage of Cerezyme – updated treatment recommendations required", "press_release": "Yes", "related_medicine_referral": "Cerezyme", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/08/2009", "last_updated_date": "14/08/2009", "news_url": "https://www.ema.europa.eu/en/news/supply-shortage-cerezyme-updated-treatment-recommendations-required" }, { "title": "EudraGMP 2.0 gives public access to information about good manufacturing practice (GMP)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections", "news_summary": "", "first_published_date": "04/08/2009", "last_updated_date": "04/08/2009", "news_url": "https://www.ema.europa.eu/en/news/eudragmp-20-gives-public-access-information-about-good-manufacturing-practice-gmp" }, { "title": "European Medicines Agency and U.S. Food and Drug Administration (FDA) launch Good Clinical Practice Initiative", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "03/08/2009", "last_updated_date": "03/08/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-fda-launch-good-clinical-practice-initiative" }, { "title": "Meeting highlights from the Paediatric Committee: 22 - 24 July 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "31/07/2009", "last_updated_date": "31/07/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-22-24-july-2009" }, { "title": "European Medicines Agency update on safety of insulin glargine - Update", "press_release": "Yes", "related_medicine_referral": "Lantus;Toujeo (previously Optisulin)", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "29/07/2009", "last_updated_date": "29/07/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-safety-insulin-glargine-update" }, { "title": "GlaxoSmithKline withdraws its marketing authorisation application for Bosatria (mepolizumab)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/07/2009", "last_updated_date": "29/07/2009", "news_url": "https://www.ema.europa.eu/en/news/glaxosmithkline-withdraws-its-marketing-authorisation-application-bosatria-mepolizumab" }, { "title": "European Medicines Agency review of pandemic vaccines underway", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "24/07/2009", "last_updated_date": "24/07/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-review-pandemic-vaccines-underway" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,20-23 July 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "24/07/2009", "last_updated_date": "24/07/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use20-23-july-2009" }, { "title": "Gendux Molecular Limited withdraws its marketing authorisation application for Contusugene ladenovec Gendux (contusugene ladenovec)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/07/2009", "last_updated_date": "23/07/2009", "news_url": "https://www.ema.europa.eu/en/news/gendux-molecular-limited-withdraws-its-marketing-authorisation-application-contusugene-ladenovec-gendux-contusugene-ladenovec" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 14-16 July 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/07/2009", "last_updated_date": "17/07/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-14-16-july-2009" }, { "title": "Meeting highlights from the Paediatric Committee: 24 - 26 June 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "01/07/2009", "last_updated_date": "01/07/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-24-26-june-2009" }, { "title": "Committee for Advanced Therapies adopts first classification recommendation for an advanced therapy medicinal product", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "30/06/2009", "last_updated_date": "30/06/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-adopts-first-classification-recommendation-advanced-therapy-medicinal-product" }, { "title": "Public statement on the recommendation to lift the suspension of the marketing authorisation for Optison (perflutren)", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/06/2009", "last_updated_date": "29/06/2009", "news_url": "https://www.ema.europa.eu/en/news/public-statement-recommendation-lift-suspension-marketing-authorisation-optison-perflutren" }, { "title": "European Medicines Agency update on safety of insulin glargine", "press_release": "Yes", "related_medicine_referral": "Lantus;Toujeo (previously Optisulin)", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "29/06/2009", "last_updated_date": "29/06/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-safety-insulin-glargine" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,22-25 June 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2009", "last_updated_date": "26/06/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use22-25-june-2009" }, { "title": "European Medicines Agency recommends first marketing authorisation for an advanced therapy medicinal product", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Medicines", "news_summary": "", "first_published_date": "26/06/2009", "last_updated_date": "26/06/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-first-marketing-authorisation-advanced-therapy-medicinal-product" }, { "title": "European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/06/2009", "last_updated_date": "25/06/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-withdrawal-dextropropoxyphene-containing-medicines" }, { "title": "Supply shortages of Cerezyme and Fabrazyme - priority access for patients most in need of treatment recommended", "press_release": "Yes", "related_medicine_referral": "Cerezyme;Fabrazyme", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/06/2009", "last_updated_date": "25/06/2009", "news_url": "https://www.ema.europa.eu/en/news/supply-shortages-cerezyme-fabrazyme-priority-access-patients-most-need-treatment-recommended" }, { "title": "Menarini International Operations Luxembourg withdraws its marketing authorisation application for Factive (gemifloxacin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/06/2009", "last_updated_date": "23/06/2009", "news_url": "https://www.ema.europa.eu/en/news/menarini-international-operations-luxembourg-withdraws-its-marketing-authorisation-application-factive-gemifloxacin" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 16-18 June 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/06/2009", "last_updated_date": "19/06/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-16-18-june-2009" }, { "title": "European Medicines Agency launches public consultation on new transparency policy", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/06/2009", "last_updated_date": "19/06/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-public-consultation-new-transparency-policy" }, { "title": "Joint TAIEX/EMEA Central Eastern European Countries Forum on the regulation of veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/06/2009", "last_updated_date": "18/06/2009", "news_url": "https://www.ema.europa.eu/en/news/joint-taiex-emea-central-eastern-european-countries-forum-regulation-veterinary-medicinal-products" }, { "title": "European public health agencies evaluate antibiotic resistance of Staphylococcus aureus", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Antimicrobial resistance", "news_summary": "", "first_published_date": "16/06/2009", "last_updated_date": "16/06/2009", "news_url": "https://www.ema.europa.eu/en/news/european-public-health-agencies-evaluate-antibiotic-resistance-staphylococcus-aureus" }, { "title": "WHO declares influenza pandemic – European Medicines Agency initiates crisis-management plan", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "12/06/2009", "last_updated_date": "12/06/2009", "news_url": "https://www.ema.europa.eu/en/news/who-declares-influenza-pandemic-european-medicines-agency-initiates-crisis-management-plan" }, { "title": "EU-wide recall of Raptiva (efalizumab) to be initiated", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/06/2009", "last_updated_date": "08/06/2009", "news_url": "https://www.ema.europa.eu/en/news/eu-wide-recall-raptiva-efalizumab-be-initiated" }, { "title": "Meeting highlights from the Paediatric Committee:27 - 29 May 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "03/06/2009", "last_updated_date": "03/06/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee27-29-may-2009" }, { "title": "European Medicines Agency introduces new, faster scientific advice procedure", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "31/05/2009", "last_updated_date": "31/05/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-introduces-new-faster-scientific-advice-procedure" }, { "title": "European Medicines Agency recommends lifting of supply and treatment restrictions for Neupro", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "29/05/2009", "last_updated_date": "29/05/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-lifting-supply-treatment-restrictions-neupro" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use, 26-29 May 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "29/05/2009", "last_updated_date": "29/05/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-26-29-may-2009" }, { "title": "Public statement on possible interaction between clopidogrel and proton pump inhibitors", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/05/2009", "last_updated_date": "29/05/2009", "news_url": "https://www.ema.europa.eu/en/news/public-statement-possible-interaction-between-clopidogrel-proton-pump-inhibitors" }, { "title": "BioPartners GmbH withdraws its application for Biferonex (interferon beta-1a)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/05/2009", "last_updated_date": "29/05/2009", "news_url": "https://www.ema.europa.eu/en/news/biopartners-gmbh-withdraws-its-application-biferonex-interferon-beta-1a" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 12-14 May 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/05/2009", "last_updated_date": "15/05/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-12-14-may-2009" }, { "title": "Sepracor Pharmaceuticals Ltd withdraws its marketing authorisation application for Lunivia (eszopiclone)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/05/2009", "last_updated_date": "15/05/2009", "news_url": "https://www.ema.europa.eu/en/news/sepracor-pharmaceuticals-ltd-withdraws-its-marketing-authorisation-application-lunivia-eszopiclone" }, { "title": "Committee for veterinary medicinal products: 43rd meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/05/2009", "last_updated_date": "12/05/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-43rd-meeting" }, { "title": "European Medicines Agency recommendations on extension of shelf life for Tamiflu", "press_release": "Yes", "related_medicine_referral": "Tamiflu", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "08/05/2009", "last_updated_date": "08/05/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommendations-extension-shelf-life-tamiflu" }, { "title": "European Medicines Agency gives guidance for use of antiviral medicines in case of a novel influenza A/H1N1 pandemic", "press_release": "Yes", "related_medicine_referral": "Tamiflu", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "08/05/2009", "last_updated_date": "08/05/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-guidance-use-antiviral-medicines-case-novel-influenza-h1n1-pandemic" }, { "title": "Meeting highlights from the Paediatric Committee: 28 - 30 April 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "05/05/2009", "last_updated_date": "05/05/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-28-30-april-2009" }, { "title": "European Medicines Agency prepares for approval of pandemic vaccines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "30/04/2009", "last_updated_date": "30/04/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-prepares-approval-pandemic-vaccines" }, { "title": "EMEA-coordinated PROTECT project has been accepted for funding by the Innovative Medicines Initiative joint undertaking", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "29/04/2009", "last_updated_date": "29/04/2009", "news_url": "https://www.ema.europa.eu/en/news/emea-coordinated-protect-project-has-been-accepted-funding-innovative-medicines-initiative-joint-undertaking" }, { "title": "Meeting highlights from the Paediatric Committee: 1 - 3 April 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "24/04/2009", "last_updated_date": "24/04/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-1-3-april-2009" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use, 20-23 April 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-20-23-april-2009" }, { "title": "Teva Pharma B.V. withdraws its marketing authorisation application for Clopidogrel Teva Pharma (clopidogrel hydrobromide)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "news_url": "https://www.ema.europa.eu/en/news/teva-pharma-bv-withdraws-its-marketing-authorisation-application-clopidogrel-teva-pharma-clopidogrel-hydrobromide" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 15-17 April 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/04/2009", "last_updated_date": "20/04/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-15-17-april-2009" }, { "title": "European Medicines Agency, European Commission and Health Canada agree implementation plan for confidentiality arrangement", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "08/04/2009", "last_updated_date": "08/04/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-european-commission-health-canada-agree-implementation-plan-confidentiality-arrangement" }, { "title": "European Medicines Agency makes recommendations on the use ofantimicrobials in livestock and companion animals in relation to the risk ofMRSA infection in animals", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "27/03/2009", "last_updated_date": "27/03/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-makes-recommendations-use-ofantimicrobials-livestock-companion-animals-relation-risk-ofmrsa-infection-animals" }, { "title": "Bristol-Myers Squibb Pharma EEIG withdraws its marketing authorisation application for Ixempra", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/03/2009", "last_updated_date": "19/03/2009", "news_url": "https://www.ema.europa.eu/en/news/bristol-myers-squibb-pharma-eeig-withdraws-its-marketing-authorisation-application-ixempra" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,16-19 March 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "19/03/2009", "last_updated_date": "19/03/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use16-19-march-2009" }, { "title": "EMEA/IFAH Infoday: latest developments in scientific review, legislation and marketing authorisation procedures for veterinary medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/03/2009", "last_updated_date": "18/03/2009", "news_url": "https://www.ema.europa.eu/en/news/emea-ifah-infoday-latest-developments-scientific-review-legislation-marketing-authorisation-procedures-veterinary-medicines" }, { "title": "Schering-Plough Europe withdraws its marketing authorisation application for Cylatron (peginterferon alfa-2b)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "16/03/2009", "last_updated_date": "16/03/2009", "news_url": "https://www.ema.europa.eu/en/news/schering-plough-europe-withdraws-its-marketing-authorisation-application-cylatron-peginterferon-alfa-2b" }, { "title": "Meeting highlights from the Paediatric Committee: 4 - 6 March 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "13/03/2009", "last_updated_date": "13/03/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-4-6-march-2009" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 10-12 March 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/03/2009", "last_updated_date": "13/03/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-10-12-march-2009" }, { "title": "Management Board re-elects Vice-chair and starts budget discussions for 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/03/2009", "last_updated_date": "10/03/2009", "news_url": "https://www.ema.europa.eu/en/news/management-board-re-elects-vice-chair-starts-budget-discussions-2010" }, { "title": "Orion Corporation withdraws its application for an extension of indication for Stalevo (levodopa/carbidopa/entacapone)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "10/03/2009", "last_updated_date": "10/03/2009", "news_url": "https://www.ema.europa.eu/en/news/orion-corporation-withdraws-its-application-extension-indication-stalevo-levodopa-carbidopa-entacapone" }, { "title": "Review of field safety data by the European Medicines Agency finds a goodsafety record for inactivated bluetongue emergency vaccines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/02/2009", "last_updated_date": "20/02/2009", "news_url": "https://www.ema.europa.eu/en/news/review-field-safety-data-european-medicines-agency-finds-goodsafety-record-inactivated-bluetongue-emergency-vaccines" }, { "title": "European Medicines Agency recommends continued vaccination with Gardasil", "press_release": "Yes", "related_medicine_referral": "Silgard;Gardasil", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/02/2009", "last_updated_date": "19/02/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-continued-vaccination-gardasil" }, { "title": "European Medicines Agency recommends new contraindication and warning for Rasilez and other aliskiren medicines", "press_release": "Yes", "related_medicine_referral": "Riprazo", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/02/2009", "last_updated_date": "19/02/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-contraindication-warning-rasilez-other-aliskiren-medicines" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,16-19 February 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "19/02/2009", "last_updated_date": "19/02/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use16-19-february-2009" }, { "title": "European Medicines Agency recommends suspension of the marketing authorisation of Raptiva (efalizumab)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "19/02/2009", "last_updated_date": "19/02/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisation-raptiva-efalizumab" }, { "title": "European Medicines Agency recommends authorisation of first bluetongue vaccine through centralised procedure", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/02/2009", "last_updated_date": "18/02/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-first-bluetongue-vaccine-through-centralised-procedure" }, { "title": "Merck Sharp & Dohme Ltd withdraws its marketing authorisation application for Vorinostat MSD", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/02/2009", "last_updated_date": "17/02/2009", "news_url": "https://www.ema.europa.eu/en/news/merck-sharp-dohme-ltd-withdraws-its-marketing-authorisation-application-vorinostat-msd" }, { "title": "Committee for Advanced Therapies (CAT) elects chair and vice-chair", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Advanced therapies", "news_summary": "", "first_published_date": "16/02/2009", "last_updated_date": "16/02/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-advanced-therapies-cat-elects-chair-vice-chair" }, { "title": "AstraZeneca withdraws its application for Ximelagatran 36-mg film-coated tablets", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "16/02/2009", "last_updated_date": "16/02/2009", "news_url": "https://www.ema.europa.eu/en/news/astrazeneca-withdraws-its-application-ximelagatran-36-mg-film-coated-tablets" }, { "title": "Meeting highlights from the Paediatric Committee: 4 - 6 February 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "13/02/2009", "last_updated_date": "13/02/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-4-6-february-2009" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 10-12 February 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/02/2009", "last_updated_date": "13/02/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-10-12-february-2009" }, { "title": "Public Statement on Fee Reductions for Designated Orphan Medicinal Products", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/02/2009", "last_updated_date": "04/02/2009", "news_url": "https://www.ema.europa.eu/en/news/public-statement-fee-reductions-designated-orphan-medicinal-products" }, { "title": "European Medicines Agency welcomes continuation of D:A:D study", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "03/02/2009", "last_updated_date": "03/02/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-continuation-dad-study" }, { "title": "EPAR summaries for the public: A further step for the provision of better information about medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/02/2009", "last_updated_date": "02/02/2009", "news_url": "https://www.ema.europa.eu/en/news/epar-summaries-public-further-step-provision-better-information-about-medicines" }, { "title": "European Medicines Agency recommends new contraindication for Fareston (toremifene)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/01/2009", "last_updated_date": "22/01/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-contraindication-fareston-toremifene" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 January 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "22/01/2009", "last_updated_date": "22/01/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use19-22-january-2009" }, { "title": "European Medicines Agency makes recommendations for safer use of Ritalin and other methylphenidate-containing medicines in the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/01/2009", "last_updated_date": "22/01/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-makes-recommendations-safer-use-ritalin-other-methylphenidate-containing-medicines-eu" }, { "title": "Meeting highlights from the Paediatric Committee: 7 - 9 January 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "16/01/2009", "last_updated_date": "16/01/2009", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-7-9-january-2009" }, { "title": "European Medicines Agency holds first meeting of Committee for Advanced Therapies (CAT)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Advanced therapies;Medicines;Advanced therapies;Innovation", "news_summary": "", "first_published_date": "16/01/2009", "last_updated_date": "16/01/2009", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-holds-first-meeting-committee-advanced-therapies-cat" }, { "title": "Priority access for children during Myozyme supply shortage", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "16/01/2009", "last_updated_date": "16/01/2009", "news_url": "https://www.ema.europa.eu/en/news/priority-access-children-during-myozyme-supply-shortage" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 13-15 January 2009", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/01/2009", "last_updated_date": "16/01/2009", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-13-15-january-2009" }, { "title": "Gendux Molecular Limited withdraws its marketing authorisation application for Advexin (contusugene ladenovec)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/12/2008", "last_updated_date": "19/12/2008", "news_url": "https://www.ema.europa.eu/en/news/gendux-molecular-limited-withdraws-its-marketing-authorisation-application-advexin-contusugene-ladenovec" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,15-18 December 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "18/12/2008", "last_updated_date": "18/12/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use15-18-december-2008" }, { "title": "EMEA Management Board adopts work programme for a busy year ahead and agrees to move towards greater transparency of its meetings", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/12/2008", "last_updated_date": "17/12/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-management-board-adopts-work-programme-busy-year-ahead-agrees-move-towards-greater-transparency-its-meetings" }, { "title": "Meeting highlights from the Paediatric Committee: 10 - 12 December 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "17/12/2008", "last_updated_date": "17/12/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-10-12-december-2008" }, { "title": "Janssen-Cilag International N.V. withdraws its application for an extension of indication for Invega (paliperidone)", "press_release": "Yes", "related_medicine_referral": "Invega", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "17/12/2008", "last_updated_date": "17/12/2008", "news_url": "https://www.ema.europa.eu/en/news/janssen-cilag-international-nv-withdraws-its-application-extension-indication-invega-paliperidone" }, { "title": "European Medicines Agency recommends suspension of classical swine fever vaccine Porcilis Pesti", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "12/12/2008", "last_updated_date": "12/12/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-classical-swine-fever-vaccine-porcilis-pesti" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 9-11 December 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/12/2008", "last_updated_date": "12/12/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-9-11-december-2008" }, { "title": "Oncoscience AG withdraws its application for Theraloc (nimotuzumab)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "04/12/2008", "last_updated_date": "04/12/2008", "news_url": "https://www.ema.europa.eu/en/news/oncoscience-ag-withdraws-its-application-theraloc-nimotuzumab" }, { "title": "Meeting highlights from the Paediatric Committee:12 - 14 November 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "26/11/2008", "last_updated_date": "26/11/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee12-14-november-2008" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,17-20 November 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "21/11/2008", "last_updated_date": "21/11/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use17-20-november-2008" }, { "title": "Pfizer withdraws its application to change the marketing authorisation for Viagra 50 mg (sildenafil) from prescription-only to non-prescription", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/11/2008", "last_updated_date": "20/11/2008", "news_url": "https://www.ema.europa.eu/en/news/pfizer-withdraws-its-application-change-marketing-authorisation-viagra-50-mg-sildenafil-prescription-only-non-prescription" }, { "title": "European Medicines Agency recommends the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/11/2008", "last_updated_date": "20/11/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisation-ionsys-fentanyl-hydrochloride" }, { "title": "Successful Rijeka conference strengthens EU-Croatian cooperation on medicines regulation", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/11/2008", "last_updated_date": "18/11/2008", "news_url": "https://www.ema.europa.eu/en/news/successful-rijeka-conference-strengthens-eu-croatian-cooperation-medicines-regulation" }, { "title": "Sanofi-Aventis Pharma S.A. withdraws its application for an extension of indication for Taxotere and Docetaxel Winthrop (docetaxel)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/11/2008", "last_updated_date": "17/11/2008", "news_url": "https://www.ema.europa.eu/en/news/sanofi-aventis-pharma-sa-withdraws-its-application-extension-indication-taxotere-docetaxel-winthrop-docetaxel" }, { "title": "Novagali Pharma S.A. withdraws its marketing authorisation application for Vekacia (ciclosporin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/11/2008", "last_updated_date": "17/11/2008", "news_url": "https://www.ema.europa.eu/en/news/novagali-pharma-sa-withdraws-its-marketing-authorisation-application-vekacia-ciclosporin" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 11-13 November 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/11/2008", "last_updated_date": "14/11/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-11-13-november-2008" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,20-23 October 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "24/10/2008", "last_updated_date": "24/10/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use20-23-october-2008" }, { "title": "Astellas withdraws its marketing authorisation application for Vibativ (telavancin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/10/2008", "last_updated_date": "24/10/2008", "news_url": "https://www.ema.europa.eu/en/news/astellas-withdraws-its-marketing-authorisation-application-vibativ-telavancin" }, { "title": "Meeting highlights from the Paediatric Committee: 15 - 17 October 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "24/10/2008", "last_updated_date": "24/10/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-15-17-october-2008" }, { "title": "The European Medicines Agency recommends suspension of the marketing authorisation of Acomplia", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/10/2008", "last_updated_date": "23/10/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisation-acomplia" }, { "title": "European Medicines Agency recommends first switch from prescription-only to non-prescription for a centrally authorised medicine", "press_release": "Yes", "related_medicine_referral": "Alli (previously Orlistat GSK)", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/10/2008", "last_updated_date": "23/10/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-first-switch-prescription-only-non-prescription-centrally-authorised-medicine" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 14-16 October 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/10/2008", "last_updated_date": "17/10/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-14-16-october-2008" }, { "title": "Wyeth Europa Ltd withdraws its marketing authorisation application for Ellefore", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/10/2008", "last_updated_date": "15/10/2008", "news_url": "https://www.ema.europa.eu/en/news/wyeth-europa-ltd-withdraws-its-marketing-authorisation-application-ellefore" }, { "title": "EMEA half-year report for 2008 shows activities to be on target, with a marked increase in the provision of scientific advice", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/10/2008", "last_updated_date": "08/10/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-half-year-report-2008-shows-activities-be-target-marked-increase-provision-scientific-advice" }, { "title": "Medicines regulators on both sides of the Atlantic confirm commitment to cooperation on medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "07/10/2008", "last_updated_date": "07/10/2008", "news_url": "https://www.ema.europa.eu/en/news/medicines-regulators-both-sides-atlantic-confirm-commitment-cooperation-medicines" }, { "title": "Public statement on the current shortage of radiopharmaceuticals in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/10/2008", "last_updated_date": "01/10/2008", "news_url": "https://www.ema.europa.eu/en/news/public-statement-current-shortage-radiopharmaceuticals-european-union" }, { "title": "Meeting highlights from the Paediatric Committee: 17 - 19 September 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "28/09/2008", "last_updated_date": "28/09/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-17-19-september-2008" }, { "title": "UCB Pharma withdraws its marketing authorisation application for Lacosamide Pain UCB Pharma", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/09/2008", "last_updated_date": "26/09/2008", "news_url": "https://www.ema.europa.eu/en/news/ucb-pharma-withdraws-its-marketing-authorisation-application-lacosamide-pain-ucb-pharma" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,22-25 September 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "25/09/2008", "last_updated_date": "25/09/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use22-25-september-2008" }, { "title": "European Medicines Agency makes first recommendation for use of a medicine in children based on PIP data", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "25/09/2008", "last_updated_date": "25/09/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-makes-first-recommendation-use-medicine-children-based-pip-data" }, { "title": "Takeda withdraws its marketing authorisation application for Ramelteon", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/09/2008", "last_updated_date": "25/09/2008", "news_url": "https://www.ema.europa.eu/en/news/takeda-withdraws-its-marketing-authorisation-application-ramelteon" }, { "title": "European Medicines Agency recommends update of product information of Tysabri and risk of progressive multifocal leukoencephalopathy (PML)", "press_release": "Yes", "related_medicine_referral": "Tysabri", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "25/09/2008", "last_updated_date": "25/09/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-update-product-information-tysabri-risk-progressive-multifocal-leukoencephalopathy-pml" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 16-18 September 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/09/2008", "last_updated_date": "19/09/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-16-18-september-2008" }, { "title": "Pfizer withdraws its marketing authorisation application for Exulett (dalbavancin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "10/09/2008", "last_updated_date": "10/09/2008", "news_url": "https://www.ema.europa.eu/en/news/pfizer-withdraws-its-marketing-authorisation-application-exulett-dalbavancin" }, { "title": "EMEA releases guidelines on development of medicines for Alzheimer's disease and Parkinson's disease", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "04/09/2008", "last_updated_date": "04/09/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-releases-guidelines-development-medicines-alzheimers-disease-parkinsons-disease" }, { "title": "Meeting highlights from the Paediatric Committee: 29 - 31 July 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "04/09/2008", "last_updated_date": "04/09/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-29-31-july-2008" }, { "title": "Meeting highlights from the Paediatric Committee: 2 - 4 July 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "04/09/2008", "last_updated_date": "04/09/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-2-4-july-2008" }, { "title": "Meeting highlights from the Paediatric Committee: 2 - 4 June 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "04/09/2008", "last_updated_date": "04/09/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-2-4-june-2008" }, { "title": "Meeting highlights from the Paediatric Committee: 27 - 29 August 2008", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "04/09/2008", "last_updated_date": "04/09/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-27-29-august-2008" }, { "title": "European Medicines Agency update on progressive multifocal leukoencephalopathy (PML) and Tysabri", "press_release": "Yes", "related_medicine_referral": "Tysabri", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "13/08/2008", "last_updated_date": "13/08/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-progressive-multifocal-leukoencephalopathy-pml-tysabri" }, { "title": "Pharmion Ltd withdraws its marketing authorisation application forOrplatna (satraplatin)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/08/2008", "last_updated_date": "04/08/2008", "news_url": "https://www.ema.europa.eu/en/news/pharmion-ltd-withdraws-its-marketing-authorisation-application-fororplatna-satraplatin" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 July 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "25/07/2008", "last_updated_date": "25/07/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use21-24-july-2008" }, { "title": "European Medicines Agency recommends restricting the use of oral moxifloxacin-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "25/07/2008", "last_updated_date": "24/07/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-oral-moxifloxacin-containing-medicines" }, { "title": "Studies assessed by the European Medicines Agency indicate no increased risk of developing cancer for patients who have taken Viracept contaminated with ethyl mesilate", "press_release": "Yes", "related_medicine_referral": "Viracept", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "news_url": "https://www.ema.europa.eu/en/news/studies-assessed-european-medicines-agency-indicate-no-increased-risk-developing-cancer-patients-who-have-taken-viracept-contaminated-ethyl-mesilate" }, { "title": "EMEA recommends restricted use of oral norfloxacin-containing medicines in urinary infections", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-recommends-restricted-use-oral-norfloxacin-containing-medicines-urinary-infections" }, { "title": "Idea AG withdraws its marketing authorisation application for Diractin (ketoprofen)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "news_url": "https://www.ema.europa.eu/en/news/idea-ag-withdraws-its-marketing-authorisation-application-diractin-ketoprofen" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 15-17 July 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/07/2008", "last_updated_date": "18/07/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-15-17-july-2008" }, { "title": "EMEA recommends strengthening warnings and contraindications for etoricoxib-containing medicines used in the treatment of rheumatoid arthritis and ankylosing spondylitis", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2008", "last_updated_date": "26/06/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-recommends-strengthening-warnings-contraindications-etoricoxib-containing-medicines-used-treatment-rheumatoid-arthritis-ankylosing-spondylitis" }, { "title": "EMEA recommends a new warning for epoetins for their use in cancer patients", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2008", "last_updated_date": "26/06/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-recommends-new-warning-epoetins-their-use-cancer-patients" }, { "title": "EMEA recommends new warnings and contraindications for ergot-derived dopamine agonists", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2008", "last_updated_date": "26/06/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-recommends-new-warnings-contraindications-ergot-derived-dopamine-agonists" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,23-26 June 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "26/06/2008", "last_updated_date": "26/06/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use23-26-june-2008" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 17-19 June 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/06/2008", "last_updated_date": "20/06/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-17-19-june-2008" }, { "title": "First survey on patients' involvement in the European Medicines Agency's work reveals high satisfaction levels overall", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/06/2008", "last_updated_date": "20/06/2008", "news_url": "https://www.ema.europa.eu/en/news/first-survey-patients-involvement-european-medicines-agencys-work-reveals-high-satisfaction-levels-overall" }, { "title": "Euro Nippon Kayaku GmbH withdraws its marketing authorisation application for Spanidin (gusperimus)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/06/2008", "last_updated_date": "19/06/2008", "news_url": "https://www.ema.europa.eu/en/news/euro-nippon-kayaku-gmbh-withdraws-its-marketing-authorisation-application-spanidin-gusperimus" }, { "title": "EMEA recommends information on lung cancer cases to be included inExubera product information", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/06/2008", "last_updated_date": "17/06/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-recommends-information-lung-cancer-cases-be-included-inexubera-product-information" }, { "title": "Novartis Vaccines and Diagnostics S.r.l. withdraws its marketing authorisation application for the pre-pandemic vaccine Aflunov", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Vaccines", "news_summary": "", "first_published_date": "16/06/2008", "last_updated_date": "16/06/2008", "news_url": "https://www.ema.europa.eu/en/news/novartis-vaccines-diagnostics-srl-withdraws-its-marketing-authorisation-application-pre-pandemic-vaccine-aflunov" }, { "title": "EMEA public statement on the suspension of the marketing authorisation for Optison (perflutren) in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "12/06/2008", "last_updated_date": "12/06/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-public-statement-suspension-marketing-authorisation-optison-perflutren-european-union" }, { "title": "European Medicines Agency recommends measures to manage contamination of heparin-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "05/06/2008", "last_updated_date": "05/06/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-measures-manage-contamination-heparin-containing-medicines" }, { "title": "EMEA recommends changes in the storage conditions for Neupro (rotigotine)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/06/2008", "last_updated_date": "04/06/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-recommends-changes-storage-conditions-neupro-rotigotine" }, { "title": "Celgene Europe Limited withdraws its marketing authorisation application for Lenalidomide Celgene Europe (lenalidomide)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/06/2008", "last_updated_date": "04/06/2008", "news_url": "https://www.ema.europa.eu/en/news/celgene-europe-limited-withdraws-its-marketing-authorisation-application-lenalidomide-celgene-europe-lenalidomide" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,27-30 May 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "02/06/2008", "last_updated_date": "02/06/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use27-30-may-2008" }, { "title": "Sanofi-aventis withdraws its marketing authorisation application forAquilda (satavaptan)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/05/2008", "last_updated_date": "28/05/2008", "news_url": "https://www.ema.europa.eu/en/news/sanofi-aventis-withdraws-its-marketing-authorisation-application-foraquilda-satavaptan" }, { "title": "Bristol-Myers Squibb Pharma EEIG withdraws its marketing authorisationapplication for DuoCover", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/05/2008", "last_updated_date": "27/05/2008", "news_url": "https://www.ema.europa.eu/en/news/bristol-myers-squibb-pharma-eeig-withdraws-its-marketing-authorisationapplication-duocover" }, { "title": "Sanofi Pharma Bristol-Myers Squibb SNC withdraws its marketing authorisation application for DuoPlavin", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/05/2008", "last_updated_date": "27/05/2008", "news_url": "https://www.ema.europa.eu/en/news/sanofi-pharma-bristol-myers-squibb-snc-withdraws-its-marketing-authorisation-application-duoplavin" }, { "title": "DOR BIOPHARMA UK Ltd withdraws marketing authorisation application for orBec (beclomethasone dipropionate)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/05/2008", "last_updated_date": "23/05/2008", "news_url": "https://www.ema.europa.eu/en/news/dor-biopharma-uk-ltd-withdraws-marketing-authorisation-application-orbec-beclomethasone-dipropionate" }, { "title": "Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 13-15 May 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/05/2008", "last_updated_date": "16/05/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-may-2008" }, { "title": "Meeting highlights from the Paediatric Committee: 6 - 8 May 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "15/05/2008", "last_updated_date": "15/05/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-6-8-may-2008" }, { "title": "European Medicines Agency notified of recall of swine fever vaccine (Porcilis Pesti) by Intervet International BV", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "05/05/2008", "last_updated_date": "05/05/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-notified-recall-swine-fever-vaccine-porcilis-pesti-intervet-international-bv" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 April 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "29/04/2008", "last_updated_date": "29/04/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use21-24-april-2008" }, { "title": "Meeting highlights from the Paediatric Committee: 12 - 14 March 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "25/04/2008", "last_updated_date": "25/04/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-12-14-march-2008" }, { "title": "Wyeth withdraws its application to extend the marketing authorisation for Tygacil", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/04/2008", "last_updated_date": "24/04/2008", "news_url": "https://www.ema.europa.eu/en/news/wyeth-withdraws-its-application-extend-marketing-authorisation-tygacil" }, { "title": "European Medicines Agency recommendation on use of angiotensin-II-receptor antagonists during pregnancy", "press_release": "Yes", "related_medicine_referral": "Pritor;Micardis;Exforge;Imprida;Dafiro;Copalia;Aprovel;Karvea;Irbesartan Zentiva (previously Irbesartan Winthrop);Kinzalkomb;PritorPlus;Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG);CoAprovel", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "24/04/2008", "last_updated_date": "24/04/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommendation-use-angiotensin-ii-receptor-antagonists-during-pregnancy" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 15-17 April 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/04/2008", "last_updated_date": "18/04/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-15-17-april-2008" }, { "title": "Meeting highlights from the Paediatric Committee: 9 - 11 April 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "15/04/2008", "last_updated_date": "15/04/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-9-11-april-2008" }, { "title": "Further data needed to determine risk of heart attack with abacavir", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/04/2008", "last_updated_date": "02/04/2008", "news_url": "https://www.ema.europa.eu/en/news/further-data-needed-determine-risk-heart-attack-abacavir" }, { "title": "European Medicines Agency to grant fee waivers to applications for bluetongue vaccines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "01/04/2008", "last_updated_date": "01/04/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-grant-fee-waivers-applications-bluetongue-vaccines" }, { "title": "Meeting highlights from the Paediatric Committee: 13 - 15 February 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "27/03/2008", "last_updated_date": "27/03/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-13-15-february-2008" }, { "title": "European Medicines Agency recommends new contraindication for Velcade (bortezomib)", "press_release": "Yes", "related_medicine_referral": "Velcade", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/03/2008", "last_updated_date": "20/03/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-new-contraindication-velcade-bortezomib" }, { "title": "European Medicines Agency concludes new advice to doctors and patients for Tysabri (natalizumab) needed", "press_release": "Yes", "related_medicine_referral": "Tysabri", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/03/2008", "last_updated_date": "20/03/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-new-advice-doctors-patients-tysabri-natalizumab-needed" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,17-19 March 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "20/03/2008", "last_updated_date": "20/03/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use17-19-march-2008" }, { "title": "Bioenvision Ltd withdraws its application for an extension of indication for Evoltra (clofarabine)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/03/2008", "last_updated_date": "19/03/2008", "news_url": "https://www.ema.europa.eu/en/news/bioenvision-ltd-withdraws-its-application-extension-indication-evoltra-clofarabine" }, { "title": "Neurochem withdraws its marketing authorisation application for Kiacta (eprodisate disodium)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/03/2008", "last_updated_date": "17/03/2008", "news_url": "https://www.ema.europa.eu/en/news/neurochem-withdraws-its-marketing-authorisation-application-kiacta-eprodisate-disodium" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 11-13 March 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/03/2008", "last_updated_date": "14/03/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-11-13-march-2008" }, { "title": "Wyeth Europa Ltd withdraws its marketing authorisation application forPristiqs (desvenlafaxine)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "12/03/2008", "last_updated_date": "12/03/2008", "news_url": "https://www.ema.europa.eu/en/news/wyeth-europa-ltd-withdraws-its-marketing-authorisation-application-forpristiqs-desvenlafaxine" }, { "title": "EMEA reports strong performance in regulatory and public-health activities in 2007; the outlook for 2008 is even higher application numbers and a focus on advanced-therapy medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/03/2008", "last_updated_date": "10/03/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-reports-strong-performance-regulatory-public-health-activities-2007-outlook-2008-even-higher-application-numbers-focus-advanced-therapy-medicines" }, { "title": "Actelion withdraws its application for an extension of indication for Zavesca", "press_release": "Yes", "related_medicine_referral": "Zavesca", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/02/2008", "last_updated_date": "25/02/2008", "news_url": "https://www.ema.europa.eu/en/news/actelion-withdraws-its-application-extension-indication-zavesca" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,18-21 February 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "21/02/2008", "last_updated_date": "21/02/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use18-21-february-2008" }, { "title": "EMEA recommends authorisation of first pre-pandemic influenza vaccine", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/02/2008", "last_updated_date": "21/02/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-recommends-authorisation-first-pre-pandemic-influenza-vaccine" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 12-14 February 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/02/2008", "last_updated_date": "15/02/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-12-14-february-2008" }, { "title": "Public statement: Risk of peripheral neuropathy with Sebivo (telbivudine)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "14/02/2008", "last_updated_date": "14/02/2008", "news_url": "https://www.ema.europa.eu/en/news/public-statement-risk-peripheral-neuropathy-sebivo-telbivudine" }, { "title": "Ipsen Ltd withdraws its application for an extension of indication for NutropinAq", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "28/01/2008", "last_updated_date": "28/01/2008", "news_url": "https://www.ema.europa.eu/en/news/ipsen-ltd-withdraws-its-application-extension-indication-nutropinaq" }, { "title": "Meeting highlights from the Paediatric Committee: 16 - 18 January 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "25/01/2008", "last_updated_date": "25/01/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-16-18-january-2008" }, { "title": "European Medicines Agency recommends the approval of thalidomide for the treatment of rare bone-marrow cancer", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/01/2008", "last_updated_date": "24/01/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-thalidomide-treatment-rare-bone-marrow-cancer" }, { "title": "European Medicines Agency statement on the safety of Gardasil", "press_release": "Yes", "related_medicine_referral": "Silgard;Gardasil", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/01/2008", "last_updated_date": "24/01/2008", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-safety-gardasil" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 January 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "24/01/2008", "last_updated_date": "24/01/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use21-24-january-2008" }, { "title": "EMEA recommends new warnings and contraindications for rosiglitazone", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "24/01/2008", "last_updated_date": "24/01/2008", "news_url": "https://www.ema.europa.eu/en/news/emea-recommends-new-warnings-contraindications-rosiglitazone" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 15-17 January 2008", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/01/2008", "last_updated_date": "18/01/2008", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-15-17-january-2008" }, { "title": "Marvel LifeSciences Ltd withdraws its marketing authorisation applications for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "16/01/2008", "last_updated_date": "16/01/2008", "news_url": "https://www.ema.europa.eu/en/news/marvel-lifesciences-ltd-withdraws-its-marketing-authorisation-applications-insulin-human-rapid-marvel-insulin-human-long-marvel-insulin-human-30-70-mix-marvel" }, { "title": "Closer ties on medicines safety between European and Canadian regulatory authorities", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "11/01/2008", "last_updated_date": "11/01/2008", "news_url": "https://www.ema.europa.eu/en/news/closer-ties-medicines-safety-between-european-canadian-regulatory-authorities" }, { "title": "Meeting highlights from the Paediatric Committee: 18 - 20 December 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "10/01/2008", "last_updated_date": "10/01/2008", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-18-20-december-2007" }, { "title": "European Risk Management Strategy: 2008-2009 work programme adopted", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/12/2007", "last_updated_date": "20/12/2007", "news_url": "https://www.ema.europa.eu/en/news/european-risk-management-strategy-2008-2009-work-programme-adopted" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 11-13 December 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/12/2007", "last_updated_date": "14/12/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-11-13-december-2007" }, { "title": "European Medicines Agency concludes new advice to doctors and patients for Champix needed", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "14/12/2007", "last_updated_date": "14/12/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-new-advice-doctors-patients-champix-needed" }, { "title": "Guerbet withdraws its marketing authorisation application for Sinerem", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "14/12/2007", "last_updated_date": "14/12/2007", "news_url": "https://www.ema.europa.eu/en/news/guerbet-withdraws-its-marketing-authorisation-application-sinerem" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,10-13 December 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "14/12/2007", "last_updated_date": "14/12/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use10-13-december-2007" }, { "title": "European Medicines Agency recommends withdrawal of the marketing authorisations for lumiracoxib-containing medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "13/12/2007", "last_updated_date": "13/12/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-withdrawal-marketing-authorisations-lumiracoxib-containing-medicines" }, { "title": "Meeting highlights from the Paediatric Committee: 21 - 23 November 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "27/11/2007", "last_updated_date": "27/11/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-21-23-november-2007" }, { "title": "The European Union and the Food and Drug Administration working together to create common application for orphan designation for Medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/11/2007", "last_updated_date": "26/11/2007", "news_url": "https://www.ema.europa.eu/en/news/european-union-food-drug-administration-working-together-create-common-application-orphan-designation-medicines" }, { "title": "European Medicines Agency recommends suspension of marketing authorisation of aprotinin-containing medicines for systemic use", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/11/2007", "last_updated_date": "21/11/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisation-aprotinin-containing-medicines-systemic-use" }, { "title": "Novartis withdraws its application to extend the marketing authorisation for Zometa", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "20/11/2007", "last_updated_date": "20/11/2007", "news_url": "https://www.ema.europa.eu/en/news/novartis-withdraws-its-application-extend-marketing-authorisation-zometa" }, { "title": "Public statement on the cessation of marketing of exubera (Insulin human)", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/11/2007", "last_updated_date": "19/11/2007", "news_url": "https://www.ema.europa.eu/en/news/public-statement-cessation-marketing-exubera-insulin-human" }, { "title": "European Medicines Agency recommends changes in the product information for Protelos / Osseor due to the risk of severe hypersensitivity reactions", "press_release": "Yes", "related_medicine_referral": "Protelos;Osseor", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/11/2007", "last_updated_date": "16/11/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-changes-product-information-protelos-osseor-due-risk-severe-hypersensitivity-reactions" }, { "title": "INFAI withdraws its marketing authorisation application for Gastromotal", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "16/11/2007", "last_updated_date": "16/11/2007", "news_url": "https://www.ema.europa.eu/en/news/infai-withdraws-its-marketing-authorisation-application-gastromotal" }, { "title": "European Medicines Agency recommends suspension of marketing authorisations for carisoprodol-containing medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/11/2007", "last_updated_date": "16/11/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisations-carisoprodol-containing-medicinal-products" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,12-15 November 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "16/11/2007", "last_updated_date": "16/11/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use12-15-november-2007" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 6-8 November 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/11/2007", "last_updated_date": "09/11/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-6-8-november-2007" }, { "title": "First Global Animal Health Conference to enhance positive environment for veterinary medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/11/2007", "last_updated_date": "08/11/2007", "news_url": "https://www.ema.europa.eu/en/news/first-global-animal-health-conference-enhance-positive-environment-veterinary-medicines" }, { "title": "Committee on herbal medicinal products: Elects new chair and vice-chair", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "31/10/2007", "last_updated_date": "31/10/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-herbal-medicinal-products-elects-new-chair-vice-chair-0" }, { "title": "Meeting highlights from the Paediatric Committee: 24 - 26 October 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "29/10/2007", "last_updated_date": "29/10/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-24-26-october-2007" }, { "title": "Public Statement: Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2007", "last_updated_date": "23/10/2007", "news_url": "https://www.ema.europa.eu/en/news/public-statement-epoetins-risk-tumour-growth-progression-thromboembolic-events-cancer-patients-cardiovascular-risks-patients-chronic-kidney-disease" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,15-18 October 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "18/10/2007", "last_updated_date": "18/10/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use15-18-october-2007" }, { "title": "European Medicines Agency confirms positive benefit-risk balance for rosiglitazone and pioglitazone", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/10/2007", "last_updated_date": "18/10/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-confirms-positive-benefit-risk-balance-rosiglitazone-pioglitazone" }, { "title": "European Medicines Agency recommends withdrawal of marketing authorisations for cough medicines containing clobutinol", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/10/2007", "last_updated_date": "18/10/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-withdrawal-marketing-authorisations-cough-medicines-containing-clobutinol" }, { "title": "GlaxoSmithKline Biologicals withdraws its application for a scientific opinion for Globorix", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Biologicals", "news_summary": "", "first_published_date": "16/10/2007", "last_updated_date": "16/10/2007", "news_url": "https://www.ema.europa.eu/en/news/glaxosmithkline-biologicals-withdraws-its-application-scientific-opinion-globorix" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 9-11 October 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/10/2007", "last_updated_date": "15/10/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-9-11-october-2007" }, { "title": "European Medicines Agency sees strong level of applications in 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "12/10/2007", "last_updated_date": "12/10/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-sees-strong-level-applications-2007" }, { "title": "Meeting highlights from the Paediatric Committee: 26 - 28 September 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "01/10/2007", "last_updated_date": "01/10/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-26-28-september-2007" }, { "title": "European Medicines Agency's Paediatric Committee: Elects its first chairand vice-chair", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "27/09/2007", "last_updated_date": "27/09/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-paediatric-committee-elects-its-first-chairand-vice-chair" }, { "title": "European Medicines Agency recommends restricted use of nimesulide-containing medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "21/09/2007", "last_updated_date": "21/09/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricted-use-nimesulide-containing-medicinal-products" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,17-20 September 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "21/09/2007", "last_updated_date": "21/09/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use17-20-september-2007" }, { "title": "European Medicines Agency agrees on action plan following the recall of Viracept and recommends suspension of the marketing authorisation", "press_release": "Yes", "related_medicine_referral": "Viracept", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "21/09/2007", "last_updated_date": "21/09/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-agrees-action-plan-following-recall-viracept-recommends-suspension-marketing-authorisation" }, { "title": "European Medicines Agency recommends lifting of suspension for Viracept", "press_release": "Yes", "related_medicine_referral": "Viracept", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/09/2007", "last_updated_date": "20/09/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-lifting-suspension-viracept" }, { "title": "Questions and answers on the CHMP recommendation to allow Viracept back onto the market", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/09/2007", "last_updated_date": "20/09/2007", "news_url": "https://www.ema.europa.eu/en/news/questions-answers-chmp-recommendation-allow-viracept-back-market" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 11-13 September 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/09/2007", "last_updated_date": "17/09/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-11-13-september-2007" }, { "title": "Committee for Orphan Medicinal Products - September 2007 Meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "12/09/2007", "last_updated_date": "12/09/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-september-2007-meeting" }, { "title": "Meeting highlights from the Paediatric Committee: 29 - 31 August 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics;Paediatrics", "news_summary": "", "first_published_date": "05/09/2007", "last_updated_date": "05/09/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-29-31-august-2007" }, { "title": "Meeting highlights from the Paediatric Committee: 1 - 2 August 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "06/08/2007", "last_updated_date": "06/08/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-paediatric-committee-1-2-august-2007" }, { "title": "Committee for Orphan Medicinal Products - July 2007 Meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "06/08/2007", "last_updated_date": "06/08/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-july-2007-meeting" }, { "title": "EMEA completes the review of recombinant factor VIII products and inhibitor development", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "31/07/2007", "last_updated_date": "31/07/2007", "news_url": "https://www.ema.europa.eu/en/news/emea-completes-review-recombinant-factor-viii-products-inhibitor-development" }, { "title": "Schering-Plough Europe withdraws its marketing authorisation applicationfor Garenoxacin mesylate", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/07/2007", "last_updated_date": "26/07/2007", "news_url": "https://www.ema.europa.eu/en/news/schering-plough-europe-withdraws-its-marketing-authorisation-applicationfor-garenoxacin-mesylate" }, { "title": "Further questions and answers on the follow-up to the Viracept recall", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/07/2007", "last_updated_date": "26/07/2007", "news_url": "https://www.ema.europa.eu/en/news/further-questions-answers-follow-viracept-recall" }, { "title": "European Risk Management Strategy: Achievements to date", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/07/2007", "last_updated_date": "26/07/2007", "news_url": "https://www.ema.europa.eu/en/news/european-risk-management-strategy-achievements-date" }, { "title": "European Medicines Agency recommends withdrawal of medicinal products containing veralipride", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/07/2007", "last_updated_date": "23/07/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-withdrawal-medicinal-products-containing-veralipride" }, { "title": "Bausch & Lomb Ireland withdraws its marketing authorisation application for Retisert", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/07/2007", "last_updated_date": "23/07/2007", "news_url": "https://www.ema.europa.eu/en/news/bausch-lomb-ireland-withdraws-its-marketing-authorisation-application-retisert" }, { "title": "Ark Therapeutics withdraws its marketing authorisation application for Cerepro", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/07/2007", "last_updated_date": "20/07/2007", "news_url": "https://www.ema.europa.eu/en/news/ark-therapeutics-withdraws-its-marketing-authorisation-application-cerepro" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,16-19 July 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "19/07/2007", "last_updated_date": "19/07/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use16-19-july-2007" }, { "title": "European Medicines Agency holds Focus Group meeting on fibrosarcoma occurring at sites of injection of veterinary medicines in cats", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "19/07/2007", "last_updated_date": "19/07/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-holds-focus-group-meeting-fibrosarcoma-occurring-sites-injection-veterinary-medicines-cats" }, { "title": "European Medicines Agency recommends authorisation of first generic medicine for human use", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Generic and hybrid medicines;Medicines", "news_summary": "", "first_published_date": "19/07/2007", "last_updated_date": "19/07/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-authorisation-first-generic-medicine-human-use" }, { "title": "European Medicines Agency recommends Acomplia must not be used in patients on antidepressants or with major depression", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "19/07/2007", "last_updated_date": "19/07/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-acomplia-must-not-be-used-patients-antidepressants-or-major-depression" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 10 – 12 July 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/07/2007", "last_updated_date": "13/07/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-10-12-july-2007" }, { "title": "New Paediatric Committee holds its first meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Paediatrics", "news_summary": "", "first_published_date": "06/07/2007", "last_updated_date": "06/07/2007", "news_url": "https://www.ema.europa.eu/en/news/new-paediatric-committee-holds-its-first-meeting" }, { "title": "European Medicines Agency passes milestone of 40th positive opinion for an orphan medicinal product", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Rare diseases", "news_summary": "", "first_published_date": "03/07/2007", "last_updated_date": "03/07/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-passes-milestone-40th-positive-opinion-orphan-medicinal-product" }, { "title": "Committee for Orphan Medicinal Products - June 2007 Meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "27/06/2007", "last_updated_date": "27/06/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-june-2007-meeting" }, { "title": "European Medicines Agency recommends restricted use for piroxicam", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "25/06/2007", "last_updated_date": "25/06/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricted-use-piroxicam" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,18-21 June 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "22/06/2007", "last_updated_date": "22/06/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use18-21-june-2007" }, { "title": "Committee for Medicinal Products for Human Use elects new chair and vice-chair", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "19/06/2007", "last_updated_date": "19/06/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-human-use-elects-new-chair-vice-chair" }, { "title": "European Medicines Agency workshop on first-in-man clinical trials draft guideline", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "18/06/2007", "last_updated_date": "18/06/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-workshop-first-man-clinical-trials-draft-guideline" }, { "title": "Regulatory Cooperation Expanded", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/06/2007", "last_updated_date": "18/06/2007", "news_url": "https://www.ema.europa.eu/en/news/regulatory-cooperation-expanded" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 12 - 14 June 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/06/2007", "last_updated_date": "15/06/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-12-14-june-2007" }, { "title": "European Medicines Agency Paediatric Working Party meets for last time ahead of creation of new Paediatric Committee", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "11/06/2007", "last_updated_date": "11/06/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-paediatric-working-party-meets-last-time-ahead-creation-new-paediatric-committee" }, { "title": "European Medicines Agency's Management Board elects new chair and vice-chair", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/06/2007", "last_updated_date": "08/06/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-elects-new-chair-vice-chair" }, { "title": "European Medicines Agency announces recall of Viracept", "press_release": "Yes", "related_medicine_referral": "Viracept", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "06/06/2007", "last_updated_date": "06/06/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-announces-recall-viracept" }, { "title": "Protherics withdraws its marketing authorisation application for Voraxaze", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "29/05/2007", "last_updated_date": "29/05/2007", "news_url": "https://www.ema.europa.eu/en/news/protherics-withdraws-its-marketing-authorisation-application-voraxaze" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 May 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "25/05/2007", "last_updated_date": "25/05/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use21-24-may-2007" }, { "title": "European Medicines Agency statement on recent publication on cardiac safety of rosiglitazone (Avandia, Avandamet, Avaglim)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "23/05/2007", "last_updated_date": "23/05/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-recent-publication-cardiac-safety-rosiglitazone-avandia-avandamet-avaglim" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 14-15 May 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/05/2007", "last_updated_date": "16/05/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-14-15-may-2007" }, { "title": "Committee for Orphan Medicinal Products: May 2008 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "16/05/2007", "last_updated_date": "16/05/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-may-2008-meeting" }, { "title": "European Medicines Agency launches EudraGMP – the Community GMP database", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "01/05/2007", "last_updated_date": "01/05/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-eudragmp-community-gmp-database" }, { "title": "ISTA Pharma Ltd withdraws its marketing authorisation application for Vitragan", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "30/04/2007", "last_updated_date": "30/04/2007", "news_url": "https://www.ema.europa.eu/en/news/ista-pharma-ltd-withdraws-its-marketing-authorisation-application-vitragan" }, { "title": "Public Statement: European Medicines Agency starts review of the safety of epoetins", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "28/04/2007", "last_updated_date": "28/04/2007", "news_url": "https://www.ema.europa.eu/en/news/public-statement-european-medicines-agency-starts-review-safety-epoetins" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,23-26 April 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "27/04/2007", "last_updated_date": "27/04/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use23-26-april-2007" }, { "title": "European Medicines Agency concludes first accelerated assessment for a medicine for human use", "press_release": "Yes", "related_medicine_referral": "Soliris", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "27/04/2007", "last_updated_date": "27/04/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-first-accelerated-assessment-medicine-human-use" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 17-18 April 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/04/2007", "last_updated_date": "19/04/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-17-18-april-2007" }, { "title": "Committee for Orphan Medicinal Products: April 2007 Meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "16/04/2007", "last_updated_date": "16/04/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-april-2007-meeting" }, { "title": "European Medicines Agency recommends restricted use and strengthened warnings for Ketek", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "30/03/2007", "last_updated_date": "30/03/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricted-use-strengthened-warnings-ketek" }, { "title": "'First-in-man' clinical trials guideline released for public consultation", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "26/03/2007", "last_updated_date": "26/03/2007", "news_url": "https://www.ema.europa.eu/en/news/first-man-clinical-trials-guideline-released-public-consultation" }, { "title": "Insmed withdraws its marketing authorisation application for IPLEX", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/03/2007", "last_updated_date": "26/03/2007", "news_url": "https://www.ema.europa.eu/en/news/insmed-withdraws-its-marketing-authorisation-application-iplex" }, { "title": "European Medicines Agency statement on safety of Tamiflu", "press_release": "Yes", "related_medicine_referral": "Tamiflu", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/03/2007", "last_updated_date": "23/03/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-safety-tamiflu" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 March 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "23/03/2007", "last_updated_date": "23/03/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use19-22-march-2007" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 13 - 15 March 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/03/2007", "last_updated_date": "16/03/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-13-15-march-2007" }, { "title": "Eli Lilly withdraws its marketing authorisation application for ARXXANT", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/03/2007", "last_updated_date": "15/03/2007", "news_url": "https://www.ema.europa.eu/en/news/eli-lilly-withdraws-its-marketing-authorisation-application-arxxant" }, { "title": "European Medicines Agency annual report for 2006 shows record numbers of applications; assessment times in core processes significantly reduced", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "15/03/2007", "last_updated_date": "15/03/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-annual-report-2006-shows-record-numbers-applications-assessment-times-core-processes-significantly-reduced" }, { "title": "Committee for Orphan Medicinal Products: March 2007 Meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "08/03/2007", "last_updated_date": "08/03/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-march-2007-meeting" }, { "title": "Public statement: Baraclude (entecavir): Occurrence of a resistant HIV variant in a patient co-infected with HIV and HBV", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "05/03/2007", "last_updated_date": "05/03/2007", "news_url": "https://www.ema.europa.eu/en/news/public-statement-baraclude-entecavir-occurrence-resistant-hiv-variant-patient-co-infected-hiv-hbv" }, { "title": "Committee for Orphan Medicinal Products: November 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "09/11/2006", "last_updated_date": "28/02/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-november-2006-meeting" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 February 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "23/02/2007", "last_updated_date": "23/02/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use19-22-february-2007" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 13-15 February 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/02/2007", "last_updated_date": "19/02/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-13-15-february-2007" }, { "title": "European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "07/02/2007", "last_updated_date": "07/02/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-makes-recommendations-minimise-risk-nephrogenic-systemic-fibrosis-gadolinium-containing-contrast-agents" }, { "title": "Public statement: Vasovist and nephrogenic systemic fibrosis (NSF)", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "07/02/2007", "last_updated_date": "07/02/2007", "news_url": "https://www.ema.europa.eu/en/news/public-statement-vasovist-nephrogenic-systemic-fibrosis-nsf" }, { "title": "Committee for Orphan Medicinal Products: February 2007 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "07/02/2007", "last_updated_date": "07/02/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-february-2007-meeting" }, { "title": "Closer ties on medicines safety between EU and Japan", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "05/02/2007", "last_updated_date": "05/02/2007", "news_url": "https://www.ema.europa.eu/en/news/closer-ties-medicines-safety-between-eu-japan" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,22-24 January 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "25/01/2007", "last_updated_date": "25/01/2007", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use22-24-january-2007" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 16 - 18 January 2007", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/01/2007", "last_updated_date": "19/01/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-16-18-january-2007" }, { "title": "European Medicines Agency prepares for entry into force of new legislation on paediatric medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "12/01/2007", "last_updated_date": "12/01/2007", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-prepares-entry-force-new-legislation-paediatric-medicines" }, { "title": "Committee for Orphan Medicinal Products: January 2007 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "10/01/2007", "last_updated_date": "10/01/2007", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-january-2007-meeting" }, { "title": "Updated statement from European Medicines Agency on celecoxib", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/12/2006", "last_updated_date": "22/12/2006", "news_url": "https://www.ema.europa.eu/en/news/updated-statement-european-medicines-agency-celecoxib" }, { "title": "EMEA Management Board adopts the 2007 work programme and budget", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/12/2006", "last_updated_date": "21/12/2006", "news_url": "https://www.ema.europa.eu/en/news/emea-management-board-adopts-2007-work-programme-budget" }, { "title": "EMEA public statement on fee reductions for designated orphan medicinal products", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Rare diseases", "news_summary": "", "first_published_date": "18/12/2006", "last_updated_date": "18/12/2006", "news_url": "https://www.ema.europa.eu/en/news/emea-public-statement-fee-reductions-designated-orphan-medicinal-products" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 12 - 14 December 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/12/2006", "last_updated_date": "15/12/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-12-14-december-2006" }, { "title": "European Medicines Agency adopts first positive opinion for mock-up pandemic influenza vaccine", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "15/12/2006", "last_updated_date": "15/12/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-adopts-first-positive-opinion-mock-pandemic-influenza-vaccine" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,11-14 December 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "15/12/2006", "last_updated_date": "15/12/2006", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use11-14-december-2006" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 6 to 8 December 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/12/2006", "last_updated_date": "09/12/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-6-8-december-2005" }, { "title": "Fournier Laboratories withdraws its marketing authorisation application for Synordia", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/12/2006", "last_updated_date": "08/12/2006", "news_url": "https://www.ema.europa.eu/en/news/fournier-laboratories-withdraws-its-marketing-authorisation-application-synordia" }, { "title": "Committee for Orphan Medicinal Products: December 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "06/12/2006", "last_updated_date": "06/12/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-december-2006-meeting" }, { "title": "European Medicines Agency launches EudraPharm – the European medicines database", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "06/12/2006", "last_updated_date": "06/12/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-launches-eudrapharm-european-medicines-database" }, { "title": "EMEA workshop on homeopathic medicinal products concludes to strengthen harmonisation, but accept different national traditions", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/11/2006", "last_updated_date": "28/11/2006", "news_url": "https://www.ema.europa.eu/en/news/emea-workshop-homeopathic-medicinal-products-concludes-strengthen-harmonisation-accept-different-national-traditions" }, { "title": "Defect in Herceptin vials identified but supply for patients is maintained", "press_release": "Yes", "related_medicine_referral": "Herceptin", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/11/2006", "last_updated_date": "22/11/2006", "news_url": "https://www.ema.europa.eu/en/news/defect-herceptin-vials-identified-supply-patients-maintained" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,13-16 November 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "17/11/2006", "last_updated_date": "17/11/2006", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use13-16-november-2006" }, { "title": "2006 EMEA/IFAH-Europe Info Day: 'Stimulating innovation and managing risk in market access to the veterinary sector'", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/11/2006", "last_updated_date": "16/11/2006", "news_url": "https://www.ema.europa.eu/en/news/2006-emea-ifah-europe-info-day-stimulating-innovation-managing-risk-market-access-veterinary-sector" }, { "title": "The EMEA and the CMD(h) review Europe-wide experience with user consultation in the readability testing of package leaflets", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Product information", "news_summary": "", "first_published_date": "15/11/2006", "last_updated_date": "15/11/2006", "news_url": "https://www.ema.europa.eu/en/news/emea-cmdh-review-europe-wide-experience-user-consultation-readability-testing-package-leaflets" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 8 to 10 November 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/11/2006", "last_updated_date": "11/11/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-8-10-november-2005" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 7 - 9 November 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/11/2006", "last_updated_date": "10/11/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-7-9-november-2006" }, { "title": "European medicines agency appoints senior medical officer", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/11/2006", "last_updated_date": "08/11/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-appoints-senior-medical-officer" }, { "title": "Focus group meeting of CVMP experts, interested parties and member states - reflection paper on the use of fluoroquinolones in food-producing animals", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "01/11/2006", "last_updated_date": "01/11/2006", "news_url": "https://www.ema.europa.eu/en/news/focus-group-meeting-cvmp-experts-interested-parties-member-states-reflection-paper-use-fluoroquinolones-food-producing-animals" }, { "title": "EMEA Workshop on Neonates: Development of medicines for neonates needs multi disciplinary cooperation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/10/2006", "last_updated_date": "25/10/2006", "news_url": "https://www.ema.europa.eu/en/news/emea-workshop-neonates-development-medicines-neonates-needs-multi-disciplinary-cooperation" }, { "title": "European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/10/2006", "last_updated_date": "24/10/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-review-concludes-positive-benefit-risk-balance-non-selective-nsaids" }, { "title": "Novartis withdraws its application to extend the marketing authorisation for Glivec", "press_release": "Yes", "related_medicine_referral": "Glivec", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "23/10/2006", "last_updated_date": "23/10/2006", "news_url": "https://www.ema.europa.eu/en/news/novartis-withdraws-its-application-extend-marketing-authorisation-glivec" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use,16-18 October 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "", "news_summary": "", "first_published_date": "19/10/2006", "last_updated_date": "19/10/2006", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use16-18-october-2006" }, { "title": "Novo Nordisk withdraws its application to extend the marketing authorisations for NovoNorm and Prandin", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "13/10/2006", "last_updated_date": "13/10/2006", "news_url": "https://www.ema.europa.eu/en/news/novo-nordisk-withdraws-its-application-extend-marketing-authorisations-novonorm-prandin" }, { "title": "La Jolla Limited withdraws its marketing authorisation application for Riquent", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "13/10/2006", "last_updated_date": "13/10/2006", "news_url": "https://www.ema.europa.eu/en/news/la-jolla-limited-withdraws-its-marketing-authorisation-application-riquent" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 10 to 12 October 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/10/2006", "last_updated_date": "12/10/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-10-12-october-2006" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 4 to 6 October 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "07/10/2006", "last_updated_date": "07/10/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-4-6-october-2005" }, { "title": "Rise in applications for medicines in 2006, concerns over budget situation for 2007 and new transparency measures", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/10/2006", "last_updated_date": "06/10/2006", "news_url": "https://www.ema.europa.eu/en/news/rise-applications-medicines-2006-concerns-over-budget-situation-2007-new-transparency-measures" }, { "title": "Committee for Orphan Medicinal Products: October 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "04/10/2006", "last_updated_date": "04/10/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-october-2006-meeting" }, { "title": "European Medicines Agency update on review of non-selective NSAIDs", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "26/09/2006", "last_updated_date": "26/09/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-review-non-selective-nsaids" }, { "title": "Meeting highlights from the Committee for Medicinal Products for Human Use, 18-21 September 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "21/09/2006", "last_updated_date": "21/09/2006", "news_url": "https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-18-21-september-2006" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 12 to 14 September 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/09/2006", "last_updated_date": "14/09/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-12-14-september-2006" }, { "title": "Committee for Orphan Medicinal Products: September 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "07/09/2006", "last_updated_date": "07/09/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-september-2006-meeting" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 July 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "28/07/2006", "last_updated_date": "28/07/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-24-27-july-2006" }, { "title": "European Medicines Agency adopts positive opinion for avian influenza vaccines for use in birds", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "21/07/2006", "last_updated_date": "21/07/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-adopts-positive-opinion-avian-influenza-vaccines-use-birds" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 18 to 20 July 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "21/07/2006", "last_updated_date": "21/07/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-18-20-july-2006" }, { "title": "Skye Pharma PLC withdraws its application to extend the marketing authorisation for DepoCyte", "press_release": "Yes", "related_medicine_referral": "DepoCyte", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/07/2006", "last_updated_date": "21/07/2006", "news_url": "https://www.ema.europa.eu/en/news/skye-pharma-plc-withdraws-its-application-extend-marketing-authorisation-depocyte" }, { "title": "EMEA Public Statement on herbal medicinal products containing cimicifugae racemosae rhizoma - Serious hepatic reactions", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "18/07/2006", "last_updated_date": "18/07/2006", "news_url": "https://www.ema.europa.eu/en/news/emea-public-statement-herbal-medicinal-products-containing-cimicifugae-racemosae-rhizoma-serious-hepatic-reactions" }, { "title": "Committee for Orphan Medicinal Products: July 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "14/07/2006", "last_updated_date": "14/07/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-july-2006-meeting" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 26-28 June 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "29/06/2006", "last_updated_date": "29/06/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-26-28-june-2006" }, { "title": "Committee for Orphan Medicinal Products: June 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "26/06/2006", "last_updated_date": "26/06/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-june-2006-meeting" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 20 to 22 June 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "23/06/2006", "last_updated_date": "23/06/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-20-22-june-2006" }, { "title": "EMEA Management Board moves for greater transparency", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "12/06/2006", "last_updated_date": "12/06/2006", "news_url": "https://www.ema.europa.eu/en/news/emea-management-board-moves-greater-transparency" }, { "title": "Pharm Research Associates (UK) Ltd withdraws marketing authorisation application for Surfaxin", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "08/06/2006", "last_updated_date": "08/06/2006", "news_url": "https://www.ema.europa.eu/en/news/pharm-research-associates-uk-ltd-withdraws-marketing-authorisation-application-surfaxin" }, { "title": "European Medicines Agency adopts a positive opinion for the use of Prozac in the treatment of children and adolescents suffering from depression", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "06/06/2006", "last_updated_date": "06/06/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-adopts-positive-opinion-use-prozac-treatment-children-adolescents-suffering-depression" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 May 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "02/06/2006", "last_updated_date": "02/06/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-24-27-may-2006" }, { "title": "European Medicines Agency adopts first positive opinion for a medicinal product derived from transgenic biotechnology", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "02/06/2006", "last_updated_date": "02/06/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-adopts-first-positive-opinion-medicinal-product-derived-transgenic-biotechnology" }, { "title": "European quality leader of the year 2006 award goes to EMEA staff member", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/06/2006", "last_updated_date": "02/06/2006", "news_url": "https://www.ema.europa.eu/en/news/european-quality-leader-year-2006-award-goes-emea-staff-member" }, { "title": "European Union (European Commission and European Medicines Agency (EMEA)) and Food and Drug Administration (FDA) agree on guiding principles for joint FDA-EMEA voluntary genomic data submission briefing meetings", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "31/05/2006", "last_updated_date": "31/05/2006", "news_url": "https://www.ema.europa.eu/en/news/european-union-european-commission-european-medicines-agency-emea-food-drug-administration-fda-agree-guiding-principles-joint-fda-emea-voluntary-genomic-data-submission-briefing-meetings" }, { "title": "CIS bio international withdraw their application for Scintimun", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/05/2006", "last_updated_date": "21/05/2006", "news_url": "https://www.ema.europa.eu/en/news/cis-bio-international-withdraw-their-application-scintimun" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 16 to 18 May 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/05/2006", "last_updated_date": "19/05/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-16-18-may-2006" }, { "title": "Committee for Orphan Medicinal Products: May 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "17/05/2006", "last_updated_date": "17/05/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-may-2006-meeting" }, { "title": "European Medicines Agency finds no signal for decreased effectiveness of HBVAXPRO and Procomvax", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "08/05/2006", "last_updated_date": "08/05/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finds-no-signal-decreased-effectiveness-hbvaxpro-procomvax" }, { "title": "European Medicines Agency:Committee for Medicinal Products for Human Use24-27 April 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "28/04/2006", "last_updated_date": "28/04/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencycommittee-medicinal-products-human-use24-27-april-2006" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 18 to 20 April 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "21/04/2006", "last_updated_date": "21/04/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-18-20-april-2006" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 12 to 14 April 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/04/2006", "last_updated_date": "15/04/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-12-14-april-2005" }, { "title": "Novo Nordisk withdraw their application to extend the marketing authorisation for NovoSeven", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/04/2006", "last_updated_date": "06/04/2006", "news_url": "https://www.ema.europa.eu/en/news/novo-nordisk-withdraw-their-application-extend-marketing-authorisation-novoseven" }, { "title": "Committee for Orphan Medicinal Products: April 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "06/04/2006", "last_updated_date": "06/04/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-april-2006-meeting" }, { "title": "European Medicines Agency recommends cautious use of protopic/protopy and elidel", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/03/2006", "last_updated_date": "27/03/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-cautious-use-protopic-protopy-elidel" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 March 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/03/2006", "last_updated_date": "24/03/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-20-23-march-2006" }, { "title": "European Medicines Agency Management Board holds its 50th meeting:Annual report 2005 shows a reduction in applications for new medicines but suggests increases in the years to come", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/03/2006", "last_updated_date": "20/03/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-management-board-holds-its-50th-meetingannual-report-2005-shows-reduction-applications-new-medicines-suggests-increases-years-come" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 14 to 16 March 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/03/2006", "last_updated_date": "17/03/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-14-16-march-2006" }, { "title": "Cooperation on medicines regulation intensified", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/03/2006", "last_updated_date": "14/03/2006", "news_url": "https://www.ema.europa.eu/en/news/cooperation-medicines-regulation-intensified" }, { "title": "European Medicines Agency meets with avian flu vaccine manufacturers", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "09/03/2006", "last_updated_date": "09/03/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-meets-avian-flu-vaccine-manufacturers" }, { "title": "Committee for Orphan Medicinal Products: March 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "09/03/2006", "last_updated_date": "09/03/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-march-2006-meeting" }, { "title": "European Medicines Agency finalises set of guidelines on similar biological medicines and publishes two more new concept papers", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Biologicals;Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "08/03/2006", "last_updated_date": "08/03/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-set-guidelines-similar-biological-medicines-publishes-two-more-new-concept-papers" }, { "title": "Alcon Laboratories withdraws its application for RETAANE", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/03/2006", "last_updated_date": "02/03/2006", "news_url": "https://www.ema.europa.eu/en/news/alcon-laboratories-withdraws-its-application-retaane" }, { "title": "European Medicines Agency receives second application for human pandemic influenza vaccine", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "24/02/2006", "last_updated_date": "24/02/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-receives-second-application-human-pandemic-influenza-vaccine" }, { "title": "Alcon Laboratories (UK) Ltd withdraws its application to extend the marketing authorisation for Opatanol", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/02/2006", "last_updated_date": "23/02/2006", "news_url": "https://www.ema.europa.eu/en/news/alcon-laboratories-uk-ltd-withdraws-its-application-extend-marketing-authorisation-opatanol" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 February 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "23/02/2006", "last_updated_date": "23/02/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-20-23-february-2006" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 14 to 16 February 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/02/2006", "last_updated_date": "17/02/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-14-16-february-2006" }, { "title": "Committee for Orphan Medicinal Products: February 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "08/02/2006", "last_updated_date": "08/02/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-february-2006-meeting" }, { "title": "European Medicines Agency is consulting on the reflection paper on the use offluoroquinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "08/02/2006", "last_updated_date": "08/02/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-consulting-reflection-paper-use-offluoroquinolones-food-producing-animals-european-union-development-resistance-impact-human-animal-health" }, { "title": "European Medicines Agency adopts first positive opinion for a similar biological medicinal product", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/01/2006", "last_updated_date": "27/01/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-adopts-first-positive-opinion-similar-biological-medicinal-product" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 23-26 January 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "27/01/2006", "last_updated_date": "27/01/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-23-26-january-2006" }, { "title": "EMEA statement on the safety of Ketek", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/01/2006", "last_updated_date": "27/01/2006", "news_url": "https://www.ema.europa.eu/en/news/emea-statement-safety-ketek" }, { "title": "EuroGen Pharmaceuticals withdraws its application for Orathecin", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/01/2006", "last_updated_date": "23/01/2006", "news_url": "https://www.ema.europa.eu/en/news/eurogen-pharmaceuticals-withdraws-its-application-orathecin" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 17 to 18 January 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/01/2006", "last_updated_date": "19/01/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-17-18-january-2006" }, { "title": "Committee for Orphan Medicinal Products: January 2006 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "12/01/2006", "last_updated_date": "12/01/2006", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-january-2006-meeting" }, { "title": "European Medicines Agency receives first pandemic influenza vaccine application", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "06/01/2006", "last_updated_date": "06/01/2006", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-receives-first-pandemic-influenza-vaccine-application" }, { "title": "Management Board prepares groundwork in anticipation of a busy 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/12/2005", "last_updated_date": "20/12/2005", "news_url": "https://www.ema.europa.eu/en/news/management-board-prepares-groundwork-anticipation-busy-2006" }, { "title": "European Medicines Agency opens SME Office to support small and medium-sized enterprises", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;SME", "news_summary": "", "first_published_date": "15/12/2005", "last_updated_date": "15/12/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-opens-sme-office-support-small-medium-sized-enterprises" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 11-14 December 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/12/2005", "last_updated_date": "15/12/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-11-14-december-2005" }, { "title": "European Medicines Agency recommends no changes for Tamiflu safety information", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/12/2005", "last_updated_date": "15/12/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-no-changes-tamiflu-safety-information" }, { "title": "Committee for Orphan Medicinal Products: December 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "09/12/2005", "last_updated_date": "09/12/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-december-2005-meeting" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 14-17 November 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/11/2005", "last_updated_date": "17/11/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-14-17-november-2005" }, { "title": "European Medicines Agency gives first positive opinions on medicinal products for use outside the European Union", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "17/11/2005", "last_updated_date": "17/11/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-gives-first-positive-opinions-medicinal-products-use-outside-european-union" }, { "title": "European Medicines Agency update on the safety of Tamiflu", "press_release": "Yes", "related_medicine_referral": "Tamiflu", "categories": "Corporate", "topics": "Medicines", "news_summary": "", "first_published_date": "17/11/2005", "last_updated_date": "17/11/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-safety-tamiflu" }, { "title": "Committee for Orphan Medicinal Products: November 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "11/11/2005", "last_updated_date": "11/11/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-november-2005-meeting" }, { "title": "European Union (European Commission and European Medicines Agency) and Food and Drug Administration extend confidentiality arrangements for five more years", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "09/11/2005", "last_updated_date": "09/11/2005", "news_url": "https://www.ema.europa.eu/en/news/european-union-european-commission-european-medicines-agency-food-drug-administration-extend-confidentiality-arrangements-five-more-years" }, { "title": "European Medicines Agency conference on Environmental Risk Assessment for Human and Veterinary Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "28/10/2005", "last_updated_date": "28/10/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-conference-environmental-risk-assessment-human-veterinary-medicinal-products" }, { "title": "European Commission legalisation of EMEA certificates to end", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/10/2005", "last_updated_date": "28/10/2005", "news_url": "https://www.ema.europa.eu/en/news/european-commission-legalisation-emea-certificates-end" }, { "title": "European Medicines Agency public statement on the suspension of the marketing authorisation for bextra (valdecoxib) in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/10/2005", "last_updated_date": "27/10/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-public-statement-suspension-marketing-authorisation-bextra-valdecoxib-european-union" }, { "title": "Committee for Orphan Medicinal Products: October 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "25/10/2005", "last_updated_date": "25/10/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-october-2005-meeting" }, { "title": "EMEA Public Statement on review of recombinant Factor VIII (FVIII) products (Advate, Kogenate Bayer/Helixate NexGen, Kogenate/Helixate, Recombinate, ReFacto) and inhibitor development", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/10/2005", "last_updated_date": "18/10/2005", "news_url": "https://www.ema.europa.eu/en/news/emea-public-statement-review-recombinant-factor-viii-fviii-products-advate-kogenate-bayer-helixate-nexgen-kogenate-helixate-recombinate-refacto-inhibitor-development" }, { "title": "European Medicines Agency update on non-selective NSAIDs", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "17/10/2005", "last_updated_date": "17/10/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-update-non-selective-nsaids" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 10-13 October 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "13/10/2005", "last_updated_date": "13/10/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-10-13-october-2005" }, { "title": "European Medicines Agency welcomes new members and observers to its Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "30/09/2005", "last_updated_date": "30/09/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-welcomes-new-members-observers-its-management-board" }, { "title": "Thomas Lönngren reappointed as Executive Director of the European Medicines Agency", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "28/09/2005", "last_updated_date": "28/09/2005", "news_url": "https://www.ema.europa.eu/en/news/thomas-lonngren-reappointed-executive-director-european-medicines-agency" }, { "title": "European Medicines Agency statement on Herceptin", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "22/09/2005", "last_updated_date": "22/09/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-herceptin" }, { "title": "European Medicines Agency proposes new, faster scientific advice procedure", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/09/2005", "last_updated_date": "22/09/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-proposes-new-faster-scientific-advice-procedure" }, { "title": "European Medicines Agency recommends suspension of Hexavac", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/09/2005", "last_updated_date": "20/09/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-hexavac" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 12-15 September 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "15/09/2005", "last_updated_date": "15/09/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-12-15-september-2005" }, { "title": "Committee for Orphan Medicinal Products: September 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "14/09/2005", "last_updated_date": "14/09/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-september-2005-meeting" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 6 to 8 September 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/09/2005", "last_updated_date": "09/09/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-6-8-september-2005" }, { "title": "European Medicines Agency consulting on a draft guideline on pharmacovigilance for medicines used in children", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Regulatory and procedural guidance;Medicines;Paediatrics", "news_summary": "", "first_published_date": "12/08/2005", "last_updated_date": "12/08/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-consulting-draft-guideline-pharmacovigilance-medicines-used-children" }, { "title": "Use of antiretroviral treatment in HIV-patients with hepatic impairment and/or HBV/HCV co-infection", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/08/2005", "last_updated_date": "06/08/2005", "news_url": "https://www.ema.europa.eu/en/news/use-antiretroviral-treatment-hiv-patients-hepatic-impairment-or-hbv-hcv-co-infection" }, { "title": "Press Release on the cardiovascular safety of non-selective NSAIDs", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/08/2005", "last_updated_date": "02/08/2005", "news_url": "https://www.ema.europa.eu/en/news/press-release-cardiovascular-safety-non-selective-nsaids" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use25-28 July 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "27/07/2005", "last_updated_date": "27/07/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use25-28-july-2005" }, { "title": "Committee for Orphan Medicinal Products: July 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "21/07/2005", "last_updated_date": "21/07/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-july-2005-meeting" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 12 to 13 July 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/07/2005", "last_updated_date": "15/07/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-12-13-july-2005" }, { "title": "European Medicines Agency finalises new procedure for EU pharmaceutical guidelines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Regulatory and procedural guidance;Medicines", "news_summary": "", "first_published_date": "30/06/2005", "last_updated_date": "30/06/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-new-procedure-eu-pharmaceutical-guidelines" }, { "title": "Head of Veterinary Medicines Unit to leave European Medicines Agency", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Medicines", "news_summary": "", "first_published_date": "28/06/2005", "last_updated_date": "28/06/2005", "news_url": "https://www.ema.europa.eu/en/news/head-veterinary-medicines-unit-leave-european-medicines-agency" }, { "title": "European Medicines Agency concludes action on COX-2 inhibitors", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "27/06/2005", "last_updated_date": "27/06/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-action-cox-2-inhibitors" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 June 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "27/06/2005", "last_updated_date": "27/06/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-20-23-june-2005" }, { "title": "Committee for Orphan Medicinal Products: June 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "20/06/2005", "last_updated_date": "20/06/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-june-2005-meeting" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 14 to 15 June 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/06/2005", "last_updated_date": "16/06/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-14-15-june-2005" }, { "title": "European Medicines Agency's Management Board backs EMEA conflicts of interests policy", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/05/2005", "last_updated_date": "27/05/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agencys-management-board-backs-emea-conflicts-interests-policy" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 23-26 May 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/05/2005", "last_updated_date": "25/05/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-23-26-may-2005" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 17 to 18 May 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/05/2005", "last_updated_date": "19/05/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-17-18-may-2005" }, { "title": "Committee for Orphan Medicinal Products: May 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "18/05/2005", "last_updated_date": "18/05/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-may-2005-meeting" }, { "title": "European Risk Management Strategy: Progress to date and next steps", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "11/05/2005", "last_updated_date": "11/05/2005", "news_url": "https://www.ema.europa.eu/en/news/european-risk-management-strategy-progress-date-next-steps" }, { "title": "European Medicines Agency finalises review of antidepressants in children and adolescents", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "25/04/2005", "last_updated_date": "25/04/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-finalises-review-antidepressants-children-adolescents" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 18 – 21 April 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "21/04/2005", "last_updated_date": "21/04/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-18-21-april-2005" }, { "title": "Committee for Orphan Medicinal Products: April 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "12/04/2005", "last_updated_date": "12/04/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-april-2005-meeting" }, { "title": "European Medicines Agency statement on the suspension of use of Bextra", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "07/04/2005", "last_updated_date": "07/04/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-suspension-use-bextra" }, { "title": "2nd EMEA Workshop on Orphan Medicinal Products for patients' representatives and learned societies", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "18/03/2005", "last_updated_date": "18/03/2005", "news_url": "https://www.ema.europa.eu/en/news/2nd-emea-workshop-orphan-medicinal-products-patients-representatives-learned-societies" }, { "title": "European Medicines Agency publishes revised Code of Conduct", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "18/03/2005", "last_updated_date": "18/03/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-publishes-revised-code-conduct" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use14 - 17 March 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/03/2005", "last_updated_date": "17/03/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use14-17-march-2005" }, { "title": "EMEA celebrates 10th anniversary", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/03/2005", "last_updated_date": "14/03/2005", "news_url": "https://www.ema.europa.eu/en/news/emea-celebrates-10th-anniversary" }, { "title": "EMEA annual report shows rise in applications for new medicines in 2004,with further increases forecast for 2005 and 2006", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/03/2005", "last_updated_date": "14/03/2005", "news_url": "https://www.ema.europa.eu/en/news/emea-annual-report-shows-rise-applications-new-medicines-2004with-further-increases-forecast-2005-2006" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 8 to 10 March 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/03/2005", "last_updated_date": "11/03/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-8-10-march-2005" }, { "title": "European Medicines Agency statement following seizure of Avandamet tablets by US Food and Drug Administration", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "04/03/2005", "last_updated_date": "04/03/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-following-seizure-avandamet-tablets-us-food-drug-administration" }, { "title": "Public statement - European Medicines Agency announces regulatory action on COX-2 inhibitors", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "03/03/2005", "last_updated_date": "03/03/2005", "news_url": "https://www.ema.europa.eu/en/news/public-statement-european-medicines-agency-announces-regulatory-action-cox-2-inhibitors" }, { "title": "Invitation to EMEA 10th anniversary celebrations 11 March 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/03/2005", "last_updated_date": "02/03/2005", "news_url": "https://www.ema.europa.eu/en/news/invitation-emea-10th-anniversary-celebrations-11-march-2005" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use14-17 February 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2005", "last_updated_date": "17/02/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use14-17-february-2005" }, { "title": "European Medicines Agency announces regulatory action on COX-2 inhibitors", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "17/02/2005", "last_updated_date": "17/02/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-announces-regulatory-action-cox-2-inhibitors" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 8 to 10 February 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/02/2005", "last_updated_date": "11/02/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-8-10-february-2005" }, { "title": "Committee for Orphan Medicinal Products: February 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "07/02/2005", "last_updated_date": "07/02/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-february-2005-meeting" }, { "title": "European Medicines Agency appoints new Head of Unit for Veterinary medicines and inspections", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Compliance and inspections;Medicines", "news_summary": "", "first_published_date": "24/01/2005", "last_updated_date": "24/01/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-appoints-new-head-unit-veterinary-medicines-inspections" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use17-20 January 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human;Human", "topics": "Medicines", "news_summary": "", "first_published_date": "20/01/2005", "last_updated_date": "20/01/2005", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use17-20-january-2005" }, { "title": "Update from the European Medicines Agency on COX-2 inhibitors", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "20/01/2005", "last_updated_date": "20/01/2005", "news_url": "https://www.ema.europa.eu/en/news/update-european-medicines-agency-cox-2-inhibitors" }, { "title": "Committee for Orphan Medicinal Products: January 2005 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "18/01/2005", "last_updated_date": "18/01/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-january-2005-meeting" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 11-12 January 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/01/2005", "last_updated_date": "13/01/2005", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-11-12-january-2005" }, { "title": "Important new pharmacokinetic data demonstrating that REYATAZ (atazanavirsulfate) combined with NORVIR (ritonavir) and omeprazole should not be co-administered", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/12/2004", "last_updated_date": "22/12/2004", "news_url": "https://www.ema.europa.eu/en/news/important-new-pharmacokinetic-data-demonstrating-reyataz-atazanavirsulfate-combined-norvir-ritonavir-omeprazole-should-not-be-co-administered" }, { "title": "European Medicines Agency statement on celecoxib", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "17/12/2004", "last_updated_date": "17/12/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-celecoxib" }, { "title": "Management Board finalises its long-term plan and adopts workprogramme and budget for 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "17/12/2004", "last_updated_date": "17/12/2004", "news_url": "https://www.ema.europa.eu/en/news/management-board-finalises-its-long-term-plan-adopts-workprogramme-budget-2005" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 13-15 December 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/12/2004", "last_updated_date": "16/12/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-13-15-december-2004" }, { "title": "European Medicines Agency public statement on valdecoxib and parecoxib sodium. Cardiovascular risks in coronary artery bypass graft surgery and serious adverse skin reactions", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "15/12/2004", "last_updated_date": "15/12/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-public-statement-valdecoxib-parecoxib-sodium-cardiovascular-risks-coronary-artery-bypass-graft-surgery-serious-adverse-skin-reactions" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 7 to 9 December 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/12/2004", "last_updated_date": "10/12/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-7-9-december-2004" }, { "title": "Committee for Orphan Medicinal Products: December 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "10/12/2004", "last_updated_date": "10/12/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-december-2004-meeting" }, { "title": "CHMP meeting on Paroxetine and other SSRIs", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "09/12/2004", "last_updated_date": "09/12/2004", "news_url": "https://www.ema.europa.eu/en/news/chmp-meeting-paroxetine-other-ssris" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 15-18 November 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "18/11/2004", "last_updated_date": "18/11/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-15-18-november-2004" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 9 to 11 November 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/11/2004", "last_updated_date": "15/11/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-9-11-november-2004" }, { "title": "Medicines for the treatment of pain in children – EMEA workshop28 october 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines;Paediatrics", "news_summary": "", "first_published_date": "15/11/2004", "last_updated_date": "15/11/2004", "news_url": "https://www.ema.europa.eu/en/news/medicines-treatment-pain-children-emea-workshop28-october-2004" }, { "title": "European Medicines Agency to review COX-2 inhibitors", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "22/10/2004", "last_updated_date": "22/10/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-review-cox-2-inhibitors" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 18 – 21 October 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "19/10/2004", "last_updated_date": "19/10/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-18-21-october-2004" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 12 to 14 October 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/10/2004", "last_updated_date": "15/10/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-12-14-october-2004" }, { "title": "European Medicines Agency statement following withdrawal of Vioxx (rofecoxib)", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "06/10/2004", "last_updated_date": "06/10/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-statement-following-withdrawal-vioxx-rofecoxib" }, { "title": "European Medicines Agency and Food and Drug Administration publish implementation plan for confidentiality arrangement", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "04/10/2004", "last_updated_date": "04/10/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-food-drug-administration-publish-implementation-plan-confidentiality-arrangement" }, { "title": "EMEA Management Board considers road map 2010 and welcomes increase in new applications for human medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/10/2004", "last_updated_date": "01/10/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-management-board-considers-road-map-2010-welcomes-increase-new-applications-human-medicines" }, { "title": "Inauguration of the new committee on herbal medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "27/09/2004", "last_updated_date": "27/09/2004", "news_url": "https://www.ema.europa.eu/en/news/inauguration-new-committee-herbal-medicinal-products" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use 13-16 September 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "16/09/2004", "last_updated_date": "16/09/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-13-16-september-2004" }, { "title": "EMEA launches consultation on the future of EU pharmaceutical guidelines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "09/09/2004", "last_updated_date": "09/09/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-launches-consultation-future-eu-pharmaceutical-guidelines" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 6 to 7 September 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/09/2004", "last_updated_date": "08/09/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-6-7-september-2004" }, { "title": "European Medicine Agency: Committee for Medicinal Products for Human Use, 27-29 July 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "29/07/2004", "last_updated_date": "29/07/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicine-agency-committee-medicinal-products-human-use-27-29-july-2004" }, { "title": "Committee for Orphan Medicinal Products: July 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "27/07/2004", "last_updated_date": "27/07/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-july-2004-meeting" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 13 to 15 July 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/07/2004", "last_updated_date": "16/07/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-13-15-july-2004" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use, 22-23 June 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "24/06/2004", "last_updated_date": "24/06/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-22-23-june-2004" }, { "title": "Meeting of the EMEA Working Party on Herbal Medicinal Products 3 and 4 June 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal;Herbal", "topics": "", "news_summary": "", "first_published_date": "24/06/2004", "last_updated_date": "24/06/2004", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-3-4-june-2004" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 15 to 17 June 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/06/2004", "last_updated_date": "18/06/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-15-17-june-2004" }, { "title": "Committee for Orphan Medicinal Products: June 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "17/06/2004", "last_updated_date": "17/06/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-june-2004-meeting" }, { "title": "EMEA Management Board considers the Agency's road map to 2010 and approves transparency proposal for orphan drugs", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "14/06/2004", "last_updated_date": "14/06/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-management-board-considers-agencys-road-map-2010-approves-transparency-proposal-orphan-drugs" }, { "title": "European Medicines Agency: Committee for Medicinal Products for Human Use, 1-3 June 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "04/06/2004", "last_updated_date": "04/06/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-committee-medicinal-products-human-use-1-3-june-2004" }, { "title": "EMEA announces composition of its scientific committees", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/06/2004", "last_updated_date": "01/06/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-announces-composition-its-scientific-committees" }, { "title": "CHMP elects new chair and vice-chair at its first meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/06/2004", "last_updated_date": "01/06/2004", "news_url": "https://www.ema.europa.eu/en/news/chmp-elects-new-chair-vice-chair-its-first-meeting" }, { "title": "New Management Board elects its chairman and approves composition of new scientific committees", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/05/2004", "last_updated_date": "25/05/2004", "news_url": "https://www.ema.europa.eu/en/news/new-management-board-elects-its-chairman-approves-composition-new-scientific-committees" }, { "title": "SONOVUE (1) (sulphur hexafluoride): New contraindication in patients with heart disease. Restriction of use to non-cardiac imaging.", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/05/2004", "last_updated_date": "20/05/2004", "news_url": "https://www.ema.europa.eu/en/news/sonovue-1-sulphur-hexafluoride-new-contraindication-patients-heart-disease-restriction-use-non-cardiac-imaging" }, { "title": "Committee for Orphan Medicinal Products: May 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "17/05/2004", "last_updated_date": "17/05/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-may-2004-meeting" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 11 to 13 May 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/05/2004", "last_updated_date": "14/05/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-11-13-may-2004" }, { "title": "Procedural announcements", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "07/05/2004", "last_updated_date": "07/05/2004", "news_url": "https://www.ema.europa.eu/en/news/procedural-announcements" }, { "title": "New pharmaceutical legislation enters into force on 20 May 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/05/2004", "last_updated_date": "03/05/2004", "news_url": "https://www.ema.europa.eu/en/news/new-pharmaceutical-legislation-enters-force-20-may-2004" }, { "title": "European Medicines Agency Public Statement on the lifting of the suspension of the marketing authorisation for Tolcapone (Tasmar)", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "29/04/2004", "last_updated_date": "29/04/2004", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-public-statement-lifting-suspension-marketing-authorisation-tolcapone-tasmar" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products, 20-24 April 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/04/2004", "last_updated_date": "22/04/2004", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-20-24-april-2004" }, { "title": "EMEA releases recommendations for better information for patients", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/04/2004", "last_updated_date": "22/04/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-releases-recommendations-better-information-patients" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 1 - 2 April 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "19/04/2004", "last_updated_date": "19/04/2004", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-1-2-april-2004" }, { "title": "Committee for medicinal products for veterinary use: Meeting of 14 to 15 April 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/04/2004", "last_updated_date": "16/04/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-medicinal-products-veterinary-use-meeting-14-15-april-2004" }, { "title": "Committee for Orphan Medicinal Products: April 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "16/04/2004", "last_updated_date": "16/04/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-april-2004-meeting" }, { "title": "EMEA strengthens handling of safety concerns for human medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/04/2004", "last_updated_date": "15/04/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-strengthens-handling-safety-concerns-human-medicines" }, { "title": "EMEA sets out its road map to 2010", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/04/2004", "last_updated_date": "15/04/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-sets-out-its-road-map-2010" }, { "title": "EMEA launches action plan for improvements for human medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/04/2004", "last_updated_date": "01/04/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-launches-action-plan-improvements-human-medicines" }, { "title": "EMEA launches Eudra Vigilance training programme", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/04/2004", "last_updated_date": "01/04/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-launches-eudra-vigilance-training-programme" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products, 23-24 March 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/03/2004", "last_updated_date": "25/03/2004", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-23-24-march-2004" }, { "title": "EMEA annual report shows 24 positive reviews for new human medicines in 2003. Agency proposes €108 million budget for 2005", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/03/2004", "last_updated_date": "24/03/2004", "news_url": "https://www.ema.europa.eu/en/news/emea-annual-report-shows-24-positive-reviews-new-human-medicines-2003-agency-proposes-eu108-million-budget-2005" }, { "title": "Committee for veterinary medicinal products: Meeting of 16 to 18 March 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/03/2004", "last_updated_date": "19/03/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-16-18-march-2004" }, { "title": "Committee for Orphan Medicinal Products: March 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "17/03/2004", "last_updated_date": "17/03/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-march-2004-meeting" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products, 24-26 February 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/02/2004", "last_updated_date": "27/02/2004", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-24-26-february-2004" }, { "title": "Meeting of the EMEA working party on herbal medicinal products: 2 - 3 February 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "18/02/2004", "last_updated_date": "18/02/2004", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-2-3-february-2004" }, { "title": "Committee for veterinary medicinal products: Meeting of 10 to 12 February 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/02/2004", "last_updated_date": "13/02/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-10-12-february-2004" }, { "title": "Committee for Orphan Medicinal Products: February 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "09/02/2004", "last_updated_date": "09/02/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-february-2004-meeting" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products, 20-21 January 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/01/2004", "last_updated_date": "22/01/2004", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-20-21-january-2004" }, { "title": "CPMP elects new chair and vice-chair at its 100th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/01/2004", "last_updated_date": "20/01/2004", "news_url": "https://www.ema.europa.eu/en/news/cpmp-elects-new-chair-vice-chair-its-100th-meeting" }, { "title": "Committee for Orphan Medicinal Products: January 2004 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "19/01/2004", "last_updated_date": "19/01/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-january-2004-meeting" }, { "title": "Committee for veterinary medicinal products: Meeting of 13 to 15 January 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/01/2004", "last_updated_date": "16/01/2004", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-13-15-january-2004" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products 16-17 December 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/12/2003", "last_updated_date": "23/12/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-16-17-december-2003" }, { "title": "EMEA forecasts modest increase in applications in its 2004 budget and Management Board elects new chairman", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/12/2003", "last_updated_date": "19/12/2003", "news_url": "https://www.ema.europa.eu/en/news/emea-forecasts-modest-increase-applications-its-2004-budget-management-board-elects-new-chairman" }, { "title": "Committee for veterinary medicinal products: Meeting of 9 to 10 December 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/12/2003", "last_updated_date": "12/12/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-9-10-december-2003" }, { "title": "Committee for Orphan Medicinal Products: December 2003 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "08/12/2003", "last_updated_date": "08/12/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-december-2003-meeting" }, { "title": "European Medicines Agency public statement on update on hexavalent vaccines: Hexavac and Infanrix Hexa", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "01/12/2003", "last_updated_date": "01/12/2003", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-public-statement-update-hexavalent-vaccines-hexavac-infanrix-hexa" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products 18-20 November 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/11/2003", "last_updated_date": "20/11/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-18-20-november-2003" }, { "title": "Committee for veterinary medicinal products: Meeting of 11 to 13 November 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/11/2003", "last_updated_date": "14/11/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-11-13-november-2003" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 3 - 4 November 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "14/11/2003", "last_updated_date": "14/11/2003", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-3-4-november-2003" }, { "title": "Committee for Orphan Medicinal Products: November 2003 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "07/11/2003", "last_updated_date": "07/11/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-november-2003-meeting" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products 21-22 November 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/10/2003", "last_updated_date": "23/10/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-21-22-november-2003" }, { "title": "Committee for veterinary medicinal products: Meeting of 14 to 16 October 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/10/2003", "last_updated_date": "17/10/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-14-16-october-2003" }, { "title": "Committee for Orphan Medicinal Products: October 2003 meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "16/10/2003", "last_updated_date": "16/10/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-october-2003-meeting" }, { "title": "EMEA brings in new openness measures and acts to encourage development of veterinary medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/10/2003", "last_updated_date": "03/10/2003", "news_url": "https://www.ema.europa.eu/en/news/emea-brings-new-openness-measures-acts-encourage-development-veterinary-medicines" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products 23-25 November 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/09/2003", "last_updated_date": "25/09/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-23-25-november-2003" }, { "title": "EMEA and EU accession countries meet ahead of enlargement", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/09/2003", "last_updated_date": "23/09/2003", "news_url": "https://www.ema.europa.eu/en/news/emea-eu-accession-countries-meet-ahead-enlargement" }, { "title": "Committee for veterinary medicinal products: Meeting of 16 to 17 September 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/09/2003", "last_updated_date": "18/09/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-16-17-september-2003" }, { "title": "European Union-United States Food and Drug Administration bilateral meeting 12 September 2003", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "12/09/2003", "last_updated_date": "12/09/2003", "news_url": "https://www.ema.europa.eu/en/news/european-union-united-states-food-drug-administration-bilateral-meeting-12-september-2003" }, { "title": "38th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "12/09/2003", "last_updated_date": "12/09/2003", "news_url": "https://www.ema.europa.eu/en/news/38th-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products extraordinary meeting, 3 September 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/09/2003", "last_updated_date": "04/09/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-extraordinary-meeting-3-september-2003" }, { "title": "Committee for veterinary medicinal products: Meeting of 22 to 24 July 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "25/07/2003", "last_updated_date": "25/07/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-22-24-july-2003" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 22 to 24 July 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/07/2003", "last_updated_date": "25/07/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-22-24-july-2003" }, { "title": "37th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "13/07/2003", "last_updated_date": "13/07/2003", "news_url": "https://www.ema.europa.eu/en/news/37th-meeting-committee-orphan-medicinal-products" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 30 June - 1 July 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "09/07/2003", "last_updated_date": "09/07/2003", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-30-june-1-july-2003" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 24 to 26 June 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/06/2003", "last_updated_date": "27/06/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-24-26-june-2003" }, { "title": "Committee for veterinary medicinal products: Meeting of 17 to 19 June 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/06/2003", "last_updated_date": "20/06/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-17-19-june-2003" }, { "title": "36th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "16/06/2003", "last_updated_date": "16/06/2003", "news_url": "https://www.ema.europa.eu/en/news/36th-meeting-committee-orphan-medicinal-products" }, { "title": "EMEA Management Board adopts fee implementing rule and looks at the Agency's corporate governance", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/06/2003", "last_updated_date": "09/06/2003", "news_url": "https://www.ema.europa.eu/en/news/emea-management-board-adopts-fee-implementing-rule-looks-agencys-corporate-governance" }, { "title": "EMEA public statement on Refacto (moroctocog alfa): Introduction of a change to Refacto drug product specific activity specification increase of 20% in the amount of Refacto protein in each vial", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/05/2003", "last_updated_date": "27/05/2003", "news_url": "https://www.ema.europa.eu/en/news/emea-public-statement-refacto-moroctocog-alfa-introduction-change-refacto-drug-product-specific-activity-specification-increase-20-amount-refacto-protein-each-vial" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 20 to 22 May 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/05/2003", "last_updated_date": "22/05/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-20-22-may-2003" }, { "title": "EMEA public statement on Replaglinide (NovoNorm/Prandin) contraindication of concomitant use of Replaglinide and Gemfibrozil", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/05/2003", "last_updated_date": "21/05/2003", "news_url": "https://www.ema.europa.eu/en/news/emea-public-statement-replaglinide-novonorm-prandin-contraindication-concomitant-use-replaglinide-gemfibrozil" }, { "title": "Committee for veterinary medicinal products: Meeting of 13 to 14 May 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/05/2003", "last_updated_date": "15/05/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-13-14-may-2003" }, { "title": "35th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "12/05/2003", "last_updated_date": "12/05/2003", "news_url": "https://www.ema.europa.eu/en/news/35th-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 23 to 25 April 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/04/2003", "last_updated_date": "28/04/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-23-25-april-2003" }, { "title": "Metabolic and cardiovascular complications of antiretroviral combination therapy in HIV-infected patients", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/04/2003", "last_updated_date": "25/04/2003", "news_url": "https://www.ema.europa.eu/en/news/metabolic-cardiovascular-complications-antiretroviral-combination-therapy-hiv-infected-patients" }, { "title": "34th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "16/04/2003", "last_updated_date": "16/04/2003", "news_url": "https://www.ema.europa.eu/en/news/34th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: Meeting of 8 to 9 April 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/04/2003", "last_updated_date": "11/04/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-8-9-april-2003" }, { "title": "EU enlargement countries to join EMEA as observers from 1 April 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "31/03/2003", "last_updated_date": "31/03/2003", "news_url": "https://www.ema.europa.eu/en/news/eu-enlargement-countries-join-emea-observers-1-april-2003" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 24 - 25 February 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "28/03/2003", "last_updated_date": "28/03/2003", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-24-25-february-2003" }, { "title": "33rd meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "24/03/2003", "last_updated_date": "24/03/2003", "news_url": "https://www.ema.europa.eu/en/news/33rd-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 18 to 19 March 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/03/2003", "last_updated_date": "20/03/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-18-19-march-2003" }, { "title": "Committee for veterinary medicinal products: Meeting of 11 to 13 March 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/03/2003", "last_updated_date": "14/03/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-11-13-march-2003" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 18 to 20 February 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/02/2003", "last_updated_date": "24/02/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-18-20-february-2003" }, { "title": "EMEA Management Board elects new chairman and sets out proposed work programme for 2004", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/02/2003", "last_updated_date": "21/02/2003", "news_url": "https://www.ema.europa.eu/en/news/emea-management-board-elects-new-chairman-sets-out-proposed-work-programme-2004" }, { "title": "Committee for veterinary medicinal products: Meeting of 11 to 13 February 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/02/2003", "last_updated_date": "14/02/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-11-13-february-2003" }, { "title": "32nd meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "11/02/2003", "last_updated_date": "11/02/2003", "news_url": "https://www.ema.europa.eu/en/news/32nd-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the Evaluation of Medicinal Products: EudraLink Launch meeting 28-29 January 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "05/02/2003", "last_updated_date": "05/02/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-eudralink-launch-meeting-28-29-january-2003" }, { "title": "Public statement on the increased risk of serious infection and neutropenia in patients treated concurrently with Kineret (anakinra) and Enbrel (etanercept)", "press_release": "No", "related_medicine_referral": "Kineret", "categories": "", "topics": "", "news_summary": "", "first_published_date": "05/02/2003", "last_updated_date": "05/02/2003", "news_url": "https://www.ema.europa.eu/en/news/public-statement-increased-risk-serious-infection-neutropenia-patients-treated-concurrently-kineret-anakinra-enbrel-etanercept" }, { "title": "European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 21 to 23 January 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/01/2003", "last_updated_date": "23/01/2003", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-21-23-january-2003" }, { "title": "Committee for veterinary medicinal products: Meeting of 14 to 16 January 2003", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/01/2003", "last_updated_date": "17/01/2003", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-14-16-january-2003" }, { "title": "31st meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "13/01/2003", "last_updated_date": "13/01/2003", "news_url": "https://www.ema.europa.eu/en/news/31st-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 17 and 18 December 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/12/2002", "last_updated_date": "19/12/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-17-18-december-2002" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products -Meeting of 17 and 18 December 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/12/2002", "last_updated_date": "19/12/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-17-18-december-2002-0" }, { "title": "Committee for veterinary medicinal products: Meeting of 10 to 12 December 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/12/2002", "last_updated_date": "13/12/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-10-12-december-2002" }, { "title": "30th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "13/12/2002", "last_updated_date": "13/12/2002", "news_url": "https://www.ema.europa.eu/en/news/30th-meeting-committee-orphan-medicinal-products" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 4 and 5 November 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "02/12/2002", "last_updated_date": "02/12/2002", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-4-5-november-2002" }, { "title": "29th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "22/11/2002", "last_updated_date": "22/11/2002", "news_url": "https://www.ema.europa.eu/en/news/29th-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products -Meeting of 19 to 21 November 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/11/2002", "last_updated_date": "21/11/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-19-21-november-2002" }, { "title": "Committee for veterinary medicinal products: Meeting of 12 to 14 November 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/11/2002", "last_updated_date": "15/11/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-12-14-november-2002" }, { "title": "Orphan drug and paediatric clinical trials - EMEA workshop on methodological aspects of clinical trials for efficacy evaluation in small populations", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "12/11/2002", "last_updated_date": "12/11/2002", "news_url": "https://www.ema.europa.eu/en/news/orphan-drug-paediatric-clinical-trials-emea-workshop-methodological-aspects-clinical-trials-efficacy-evaluation-small-populations" }, { "title": "EMEA public statement on Refludan (Lepirudin) - Fatal anaphylactic reactions", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/10/2002", "last_updated_date": "29/10/2002", "news_url": "https://www.ema.europa.eu/en/news/emea-public-statement-refludan-lepirudin-fatal-anaphylactic-reactions" }, { "title": "Public statement on Parecoxib Sodium (Dynastat/Rayzon/Xapit) on the risk of serious hypersensitivity and skin reactions", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/10/2002", "last_updated_date": "22/10/2002", "news_url": "https://www.ema.europa.eu/en/news/public-statement-parecoxib-sodium-dynastat-rayzon-xapit-risk-serious-hypersensitivity-skin-reactions" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 15 to 17 October 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/10/2002", "last_updated_date": "18/10/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-15-17-october-2002" }, { "title": "28th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "11/10/2002", "last_updated_date": "11/10/2002", "news_url": "https://www.ema.europa.eu/en/news/28th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: Meeting of 1 to 3 October 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "04/10/2002", "last_updated_date": "04/10/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-meeting-1-3-october-2002" }, { "title": "Thirty-fifth meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/10/2002", "last_updated_date": "04/10/2002", "news_url": "https://www.ema.europa.eu/en/news/thirty-fifth-meeting-management-board" }, { "title": "27th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/09/2002", "last_updated_date": "20/09/2002", "news_url": "https://www.ema.europa.eu/en/news/27th-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 17 to 19 September 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "19/09/2002", "last_updated_date": "19/09/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-17-19-september-2002" }, { "title": "Committee for veterinary medicinal products: 80th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "06/09/2002", "last_updated_date": "06/09/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-80th-meeting" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 23 to 25 July 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/07/2002", "last_updated_date": "25/07/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-23-25-july-2002" }, { "title": "26th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/07/2002", "last_updated_date": "19/07/2002", "news_url": "https://www.ema.europa.eu/en/news/26th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: 79th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/07/2002", "last_updated_date": "12/07/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-79th-meeting" }, { "title": "25th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/07/2002", "last_updated_date": "01/07/2002", "news_url": "https://www.ema.europa.eu/en/news/25th-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 25 to 27 June 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/06/2002", "last_updated_date": "27/06/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-25-27-june-2002" }, { "title": "Committee for veterinary medicinal products: 78th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/06/2002", "last_updated_date": "14/06/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-78th-meeting" }, { "title": "1st EMEA/CPMP Workshop for Patients' Organisations – Information and Participation", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/06/2002", "last_updated_date": "06/06/2002", "news_url": "https://www.ema.europa.eu/en/news/1st-emea-cpmp-workshop-patients-organisations-information-participation" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 28 to 30 May 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "31/05/2002", "last_updated_date": "31/05/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-28-30-may-2002" }, { "title": "24th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "23/05/2002", "last_updated_date": "23/05/2002", "news_url": "https://www.ema.europa.eu/en/news/24th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: 77th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/05/2002", "last_updated_date": "17/05/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-77th-meeting" }, { "title": "23rd meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "02/05/2002", "last_updated_date": "02/05/2002", "news_url": "https://www.ema.europa.eu/en/news/23rd-meeting-committee-orphan-medicinal-products" }, { "title": "EMEA announces new Head of Unit for Communications and Networking", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/05/2002", "last_updated_date": "02/05/2002", "news_url": "https://www.ema.europa.eu/en/news/emea-announces-new-head-unit-communications-networking" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 23 to 25 April 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/04/2002", "last_updated_date": "26/04/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-23-25-april-2002" }, { "title": "Committee for veterinary medicinal products: 76th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/04/2002", "last_updated_date": "19/04/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-76th-meeting" }, { "title": "Committee for Orphan Medicinal Products adopts 100th positive opinion on designation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "26/03/2002", "last_updated_date": "26/03/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-orphan-medicinal-products-adopts-100th-positive-opinion-designation" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 19 to 21 March 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/03/2002", "last_updated_date": "21/03/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-19-21-march-2002" }, { "title": "EMEA publishes first summaries of opinions for designated orphan medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/03/2002", "last_updated_date": "21/03/2002", "news_url": "https://www.ema.europa.eu/en/news/emea-publishes-first-summaries-opinions-designated-orphan-medicines" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 11 and 12 March 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "18/03/2002", "last_updated_date": "18/03/2002", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-11-12-march-2002" }, { "title": "Committee for veterinary medicinal products: 75th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/03/2002", "last_updated_date": "15/03/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-75th-meeting" }, { "title": "21st meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "27/02/2002", "last_updated_date": "27/02/2002", "news_url": "https://www.ema.europa.eu/en/news/21st-meeting-committee-orphan-medicinal-products" }, { "title": "Thirty-third meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "22/02/2002", "last_updated_date": "22/02/2002", "news_url": "https://www.ema.europa.eu/en/news/thirty-third-meeting-management-board" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 19 to 21 February 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/02/2002", "last_updated_date": "21/02/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-19-21-february-2002" }, { "title": "Committee for veterinary medicinal products: 74th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/02/2002", "last_updated_date": "15/02/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-74th-meeting" }, { "title": "Public statement on infliximab (Remicade): Update on safety concerns", "press_release": "No", "related_medicine_referral": "Remicade", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/02/2002", "last_updated_date": "01/02/2002", "news_url": "https://www.ema.europa.eu/en/news/public-statement-infliximab-remicade-update-safety-concerns" }, { "title": "1st EMEA workshop with health professionals and academia on orphan medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases;Rare diseases", "news_summary": "", "first_published_date": "31/01/2002", "last_updated_date": "31/01/2002", "news_url": "https://www.ema.europa.eu/en/news/1st-emea-workshop-health-professionals-academia-orphan-medicinal-products" }, { "title": "20th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/01/2002", "last_updated_date": "28/01/2002", "news_url": "https://www.ema.europa.eu/en/news/20th-meeting-committee-orphan-medicinal-products" }, { "title": "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 15 to 17 January 2002", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/01/2002", "last_updated_date": "17/01/2002", "news_url": "https://www.ema.europa.eu/en/news/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-15-17-january-2002" }, { "title": "Committee for veterinary medicinal products: 73rd meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/01/2002", "last_updated_date": "10/01/2002", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-73rd-meeting" }, { "title": "Thirty-second meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/12/2001", "last_updated_date": "20/12/2001", "news_url": "https://www.ema.europa.eu/en/news/thirty-second-meeting-management-board" }, { "title": "19th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "19/12/2001", "last_updated_date": "19/12/2001", "news_url": "https://www.ema.europa.eu/en/news/19th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP): meeting of 11 to 13 December 2001", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "13/12/2001", "last_updated_date": "13/12/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-meeting-11-13-december-2001" }, { "title": "Committee for veterinary medicinal products: 72nd meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "07/12/2001", "last_updated_date": "07/12/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-72nd-meeting" }, { "title": "Committee for veterinary medicinal products: 61st meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "07/12/2001", "last_updated_date": "07/12/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-61st-meeting" }, { "title": "First EMEA workshop on ethics in clinical trials - Use of placebo in clinical trials", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/12/2001", "last_updated_date": "04/12/2001", "news_url": "https://www.ema.europa.eu/en/news/first-emea-workshop-ethics-clinical-trials-use-placebo-clinical-trials" }, { "title": "18th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "22/11/2001", "last_updated_date": "22/11/2001", "news_url": "https://www.ema.europa.eu/en/news/18th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP): meeting of 13 to 15 November 2001", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "16/11/2001", "last_updated_date": "16/11/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-meeting-13-15-november-2001" }, { "title": "Public Statement on Metalyse (Tenecteplase) - importance of correct product handling: syringe-vial assembly", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "12/11/2001", "last_updated_date": "12/11/2001", "news_url": "https://www.ema.europa.eu/en/news/public-statement-metalyse-tenecteplase-importance-correct-product-handling-syringe-vial-assembly" }, { "title": "Committee for veterinary medicinal products: 71st meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/11/2001", "last_updated_date": "09/11/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-71st-meeting" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 29 and October 2001", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "08/11/2001", "last_updated_date": "08/11/2001", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-29-october-2001" }, { "title": "17th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "05/11/2001", "last_updated_date": "05/11/2001", "news_url": "https://www.ema.europa.eu/en/news/17th-meeting-committee-orphan-medicinal-products" }, { "title": "Public statement on infliximab (Remicade) on the increased incidence of mortality and hospitalisation for worsening congestive heart failure", "press_release": "No", "related_medicine_referral": "Remicade", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/10/2001", "last_updated_date": "24/10/2001", "news_url": "https://www.ema.europa.eu/en/news/public-statement-infliximab-remicade-increased-incidence-mortality-hospitalisation-worsening-congestive-heart-failure" }, { "title": "Committee for Proprietary Medicinal Products (CPMP): meeting of 16 to 18 October 2001", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/10/2001", "last_updated_date": "19/10/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-meeting-16-18-october-2001" }, { "title": "EMEA Creates new Communications and Networking Unit", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/10/2001", "last_updated_date": "18/10/2001", "news_url": "https://www.ema.europa.eu/en/news/emea-creates-new-communications-networking-unit" }, { "title": "Committee for veterinary medicinal products: 70th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/10/2001", "last_updated_date": "11/10/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-70th-meeting" }, { "title": "Thirty-first meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/10/2001", "last_updated_date": "10/10/2001", "news_url": "https://www.ema.europa.eu/en/news/thirty-first-meeting-management-board" }, { "title": "Public Statement on Benefix (Nonacog alfa): Intensive Post-marketing Surveillance for all New patients + New Clinical Trials", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/10/2001", "last_updated_date": "04/10/2001", "news_url": "https://www.ema.europa.eu/en/news/public-statement-benefix-nonacog-alfa-intensive-post-marketing-surveillance-all-new-patients-new-clinical-trials" }, { "title": "Committee for Proprietary Medicinal Products (CPMP): meeting of 18 to 20 June 2001", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/09/2001", "last_updated_date": "25/09/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-meeting-18-20-june-2001" }, { "title": "Committee for veterinary medicinal products: 69th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/09/2001", "last_updated_date": "13/09/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-69th-meeting" }, { "title": "16th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "13/09/2001", "last_updated_date": "13/09/2001", "news_url": "https://www.ema.europa.eu/en/news/16th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: guidelines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "Regulatory and procedural guidance", "news_summary": "", "first_published_date": "15/08/2001", "last_updated_date": "15/08/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-guidelines" }, { "title": "Committee for Proprietary Medicinal Products (CPMP): meeting of 24 to 26 June 2001", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/07/2001", "last_updated_date": "27/07/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-meeting-24-26-june-2001" }, { "title": "15th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "24/07/2001", "last_updated_date": "24/07/2001", "news_url": "https://www.ema.europa.eu/en/news/15th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: 68th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/07/2001", "last_updated_date": "12/07/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-68th-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP): meeting of 26 to 28 June 2001", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/06/2001", "last_updated_date": "28/06/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-meeting-26-28-june-2001" }, { "title": "Thirtieth meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "27/06/2001", "last_updated_date": "27/06/2001", "news_url": "https://www.ema.europa.eu/en/news/thirtieth-meeting-management-board" }, { "title": "Public Statement on HerceptinN(Trastuzumab): New Pharmacokinetic Data", "press_release": "No", "related_medicine_referral": "Herceptin", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/06/2001", "last_updated_date": "19/06/2001", "news_url": "https://www.ema.europa.eu/en/news/public-statement-herceptinntrastuzumab-new-pharmacokinetic-data" }, { "title": "Committee for veterinary medicinal products: 67th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/06/2001", "last_updated_date": "14/06/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-67th-meeting" }, { "title": "14th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "13/06/2001", "last_updated_date": "13/06/2001", "news_url": "https://www.ema.europa.eu/en/news/14th-meeting-committee-orphan-medicinal-products" }, { "title": "13th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "23/05/2001", "last_updated_date": "23/05/2001", "news_url": "https://www.ema.europa.eu/en/news/13th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: 66th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "17/05/2001", "last_updated_date": "17/05/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-66th-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP): 24-25 April 2001 meeting (summary)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/05/2001", "last_updated_date": "04/05/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-24-25-april-2001-meeting-summary" }, { "title": "70th meeting of the Committee for Proprietary Medicinal Products (CPMP)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "02/05/2001", "last_updated_date": "02/05/2001", "news_url": "https://www.ema.europa.eu/en/news/70th-meeting-committee-proprietary-medicinal-products-cpmp" }, { "title": "First EMEA workshop with industry on Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "25/04/2001", "last_updated_date": "25/04/2001", "news_url": "https://www.ema.europa.eu/en/news/first-emea-workshop-industry-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: 65th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/04/2001", "last_updated_date": "19/04/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-65th-meeting" }, { "title": "EMEA Public Statement on the Recommendation to suspend the marketing authorisation for Orlaam (Levaceetylmethadol) in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/04/2001", "last_updated_date": "19/04/2001", "news_url": "https://www.ema.europa.eu/en/news/emea-public-statement-recommendation-suspend-marketing-authorisation-orlaam-levaceetylmethadol-european-union" }, { "title": "12th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "17/04/2001", "last_updated_date": "17/04/2001", "news_url": "https://www.ema.europa.eu/en/news/12th-meeting-committee-orphan-medicinal-products" }, { "title": "1st EMEA workshop for patients' organisations on Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "05/04/2001", "last_updated_date": "05/04/2001", "news_url": "https://www.ema.europa.eu/en/news/1st-emea-workshop-patients-organisations-orphan-medicinal-products" }, { "title": "69th meeting of the Committee for Proprietary Medicinal Products (CPMP)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/04/2001", "last_updated_date": "03/04/2001", "news_url": "https://www.ema.europa.eu/en/news/69th-meeting-committee-proprietary-medicinal-products-cpmp" }, { "title": "11th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "28/03/2001", "last_updated_date": "28/03/2001", "news_url": "https://www.ema.europa.eu/en/news/11th-meeting-committee-orphan-medicinal-products" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 13 - 14 March 2001", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "23/03/2001", "last_updated_date": "23/03/2001", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-13-14-march-2001" }, { "title": "Committee for veterinary medicinal products: 64th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/03/2001", "last_updated_date": "15/03/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-64th-meeting" }, { "title": "European Medicines Agency public statement on Leflunomide (Arava) - Severe and serious hepatic reactions", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "12/03/2001", "last_updated_date": "12/03/2001", "news_url": "https://www.ema.europa.eu/en/news/european-medicines-agency-public-statement-leflunomide-arava-severe-serious-hepatic-reactions" }, { "title": "68th meeting of the Committee for Proprietary Medicinal Products (CPMP)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "06/03/2001", "last_updated_date": "06/03/2001", "news_url": "https://www.ema.europa.eu/en/news/68th-meeting-committee-proprietary-medicinal-products-cpmp" }, { "title": "EMEA announces appointment of new Head of Unit for Human Medicines", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "01/03/2001", "last_updated_date": "01/03/2001", "news_url": "https://www.ema.europa.eu/en/news/emea-announces-appointment-new-head-unit-human-medicines" }, { "title": "Twenty-ninth meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/02/2001", "last_updated_date": "23/02/2001", "news_url": "https://www.ema.europa.eu/en/news/twenty-ninth-meeting-management-board" }, { "title": "Committee for veterinary medicinal products: 63rd meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/02/2001", "last_updated_date": "15/02/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-63rd-meeting" }, { "title": "Appeal procedure for Orphan Medicinal Product designation", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "09/02/2001", "last_updated_date": "09/02/2001", "news_url": "https://www.ema.europa.eu/en/news/appeal-procedure-orphan-medicinal-product-designation" }, { "title": "67th meeting of the Committee for Proprietary Medicinal Products (CPMP)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "31/01/2001", "last_updated_date": "31/01/2001", "news_url": "https://www.ema.europa.eu/en/news/67th-meeting-committee-proprietary-medicinal-products-cpmp" }, { "title": "EMEA announces new CPMP chairman and vice-chairman", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/01/2001", "last_updated_date": "23/01/2001", "news_url": "https://www.ema.europa.eu/en/news/emea-announces-new-cpmp-chairman-vice-chairman" }, { "title": "SIAMED 2000: speeding up drug regulation in Europe", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/01/2001", "last_updated_date": "18/01/2001", "news_url": "https://www.ema.europa.eu/en/news/siamed-2000-speeding-drug-regulation-europe" }, { "title": "CPMP members", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/01/2001", "last_updated_date": "18/01/2001", "news_url": "https://www.ema.europa.eu/en/news/cpmp-members" }, { "title": "9th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "18/01/2001", "last_updated_date": "18/01/2001", "news_url": "https://www.ema.europa.eu/en/news/9th-meeting-committee-orphan-medicinal-products" }, { "title": "New EMEA human medicines units announced", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/01/2001", "last_updated_date": "15/01/2001", "news_url": "https://www.ema.europa.eu/en/news/new-emea-human-medicines-units-announced" }, { "title": "Committee for veterinary medicinal products: 62nd meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/01/2001", "last_updated_date": "11/01/2001", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-62nd-meeting" }, { "title": "Twenty-eighth meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "21/12/2000", "last_updated_date": "21/12/2000", "news_url": "https://www.ema.europa.eu/en/news/twenty-eighth-meeting-management-board" }, { "title": "8th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "21/12/2000", "last_updated_date": "21/12/2000", "news_url": "https://www.ema.europa.eu/en/news/8th-meeting-committee-orphan-medicinal-products" }, { "title": "Public statement on Remicade (infliximab) - Reports of tuberculosis infections", "press_release": "No", "related_medicine_referral": "Remicade", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/12/2000", "last_updated_date": "20/12/2000", "news_url": "https://www.ema.europa.eu/en/news/public-statement-remicade-infliximab-reports-tuberculosis-infections" }, { "title": "Public Statement on Orlaam (Levacetylmethadol) - Life threatening Ventricular Rhythm Disorders", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/12/2000", "last_updated_date": "19/12/2000", "news_url": "https://www.ema.europa.eu/en/news/public-statement-orlaam-levacetylmethadol-life-threatening-ventricular-rhythm-disorders" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 66th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/12/2000", "last_updated_date": "18/12/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-66th-plenary-meeting" }, { "title": "7th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "23/11/2000", "last_updated_date": "23/11/2000", "news_url": "https://www.ema.europa.eu/en/news/7th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 65th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/11/2000", "last_updated_date": "21/11/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-65th-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 60th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/11/2000", "last_updated_date": "10/11/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-60th-meeting" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 30 and 31 October 2000", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "10/11/2000", "last_updated_date": "10/11/2000", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-30-31-october-2000" }, { "title": "Position paper on the risks associated with the use of herbal products containing aristolochia species", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "31/10/2000", "last_updated_date": "31/10/2000", "news_url": "https://www.ema.europa.eu/en/news/position-paper-risks-associated-use-herbal-products-containing-aristolochia-species" }, { "title": "6th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "31/10/2000", "last_updated_date": "31/10/2000", "news_url": "https://www.ema.europa.eu/en/news/6th-meeting-committee-orphan-medicinal-products" }, { "title": "Twenty-seventh meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/10/2000", "last_updated_date": "23/10/2000", "news_url": "https://www.ema.europa.eu/en/news/twenty-seventh-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 64th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/10/2000", "last_updated_date": "23/10/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-64th-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 59th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/10/2000", "last_updated_date": "12/10/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-59th-meeting" }, { "title": "Seminar on pre-clinical evaluation of vaccines: current experience, new adjuvants and future challenges", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "09/10/2000", "last_updated_date": "09/10/2000", "news_url": "https://www.ema.europa.eu/en/news/seminar-pre-clinical-evaluation-vaccines-current-experience-new-adjuvants-future-challenges" }, { "title": "Revised public statement on Enbrel (etanercept) - Serious haematological reactions", "press_release": "No", "related_medicine_referral": "Enbrel", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/10/2000", "last_updated_date": "03/10/2000", "news_url": "https://www.ema.europa.eu/en/news/revised-public-statement-enbrel-etanercept-serious-haematological-reactions" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 63rd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/09/2000", "last_updated_date": "25/09/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-63rd-plenary-meeting" }, { "title": "5th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "18/09/2000", "last_updated_date": "18/09/2000", "news_url": "https://www.ema.europa.eu/en/news/5th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: 58th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/09/2000", "last_updated_date": "14/09/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-58th-meeting" }, { "title": "Public Statement on Ziagen (Abacavir) - Abacavir hypersensitivity cases following an interruption of therapy", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/08/2000", "last_updated_date": "14/08/2000", "news_url": "https://www.ema.europa.eu/en/news/public-statement-ziagen-abacavir-abacavir-hypersensitivity-cases-following-interruption-therapy" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 62nd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "31/07/2000", "last_updated_date": "31/07/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-62nd-plenary-meeting" }, { "title": "Changes in the Human Medicines Evaluation Unit and nomination of new Head of Unit", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Medicines", "news_summary": "", "first_published_date": "25/07/2000", "last_updated_date": "25/07/2000", "news_url": "https://www.ema.europa.eu/en/news/changes-human-medicines-evaluation-unit-nomination-new-head-unit" }, { "title": "Committee for veterinary medicinal products: 57th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "20/07/2000", "last_updated_date": "20/07/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-57th-meeting" }, { "title": "4th meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "14/07/2000", "last_updated_date": "14/07/2000", "news_url": "https://www.ema.europa.eu/en/news/4th-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 61st plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "04/07/2000", "last_updated_date": "04/07/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-61st-plenary-meeting" }, { "title": "Personal Message from Mr Fernand Sauer, EMEA Executive Director (29 June 2000)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/06/2000", "last_updated_date": "29/06/2000", "news_url": "https://www.ema.europa.eu/en/news/personal-message-mr-fernand-sauer-emea-executive-director-29-june-2000" }, { "title": "Committee for veterinary medicinal products: 56th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "22/06/2000", "last_updated_date": "22/06/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-56th-meeting" }, { "title": "Twenty-sixth meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "09/06/2000", "last_updated_date": "09/06/2000", "news_url": "https://www.ema.europa.eu/en/news/twenty-sixth-meeting-management-board" }, { "title": "Tripartite Meeting (JPMA/PhRMA/EBC-PC) hosted by EMEA: 'Approving Innovative Medicines in 21st Century'", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "Medicines", "news_summary": "", "first_published_date": "30/05/2000", "last_updated_date": "30/05/2000", "news_url": "https://www.ema.europa.eu/en/news/tripartite-meeting-jpma-phrma-ebc-pc-hosted-emea-approving-innovative-medicines-21st-century" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 60th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/05/2000", "last_updated_date": "29/05/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-60th-plenary-meeting" }, { "title": "Meeting report of the Seventh EMEA/FEDESA Joint Info Day at the European Agency in London", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/05/2000", "last_updated_date": "22/05/2000", "news_url": "https://www.ema.europa.eu/en/news/meeting-report-seventh-emea-fedesa-joint-info-day-european-agency-london" }, { "title": "Committee for veterinary medicinal products: 55th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/05/2000", "last_updated_date": "18/05/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-55th-meeting" }, { "title": "2nd meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "16/05/2000", "last_updated_date": "16/05/2000", "news_url": "https://www.ema.europa.eu/en/news/2nd-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: 54th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/04/2000", "last_updated_date": "19/04/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-54th-meeting" }, { "title": "Inaugural meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "19/04/2000", "last_updated_date": "19/04/2000", "news_url": "https://www.ema.europa.eu/en/news/inaugural-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 59th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "17/04/2000", "last_updated_date": "17/04/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-59th-plenary-meeting" }, { "title": "Public Statement on Viramune (Nevirapine) - Severe and Life-Threatening Cutaneous and Hepatic Reactions", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "12/04/2000", "last_updated_date": "12/04/2000", "news_url": "https://www.ema.europa.eu/en/news/public-statement-viramune-nevirapine-severe-life-threatening-cutaneous-hepatic-reactions" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 58th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/03/2000", "last_updated_date": "20/03/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-58th-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 53rd meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/03/2000", "last_updated_date": "09/03/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-53rd-meeting" }, { "title": "Public Statement on the risk of drug interactions with Hypericum perforatum (St John's Wort) and antiretroviral medicinal products", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/02/2000", "last_updated_date": "28/02/2000", "news_url": "https://www.ema.europa.eu/en/news/public-statement-risk-drug-interactions-hypericum-perforatum-st-johns-wort-antiretroviral-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 57th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/02/2000", "last_updated_date": "21/02/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-57th-plenary-meeting" }, { "title": "Public statement on Insuman Infusat 100-IU/ml solution for injection in cartridges of 3.15 ml (insulin human) - Risk of leakage during use", "press_release": "No", "related_medicine_referral": "Insuman", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/02/2000", "last_updated_date": "14/02/2000", "news_url": "https://www.ema.europa.eu/en/news/public-statement-insuman-infusat-100-iu-ml-solution-injection-cartridges-315-ml-insulin-human-risk-leakage-during-use" }, { "title": "Committee for veterinary medicinal products: 52nd meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/02/2000", "last_updated_date": "10/02/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-52nd-meeting" }, { "title": "Public Statement on Ziagen (Abacavir) - Important safety Information on Hypersensitivity Reactions and Respiratory Symptoms", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/01/2000", "last_updated_date": "24/01/2000", "news_url": "https://www.ema.europa.eu/en/news/public-statement-ziagen-abacavir-important-safety-information-hypersensitivity-reactions-respiratory-symptoms" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 56th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/01/2000", "last_updated_date": "24/01/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-56th-plenary-meeting" }, { "title": "3rd meeting of the Committee for Orphan Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Human", "topics": "Rare diseases", "news_summary": "", "first_published_date": "19/01/2000", "last_updated_date": "19/01/2000", "news_url": "https://www.ema.europa.eu/en/news/3rd-meeting-committee-orphan-medicinal-products" }, { "title": "Committee for veterinary medicinal products: 51st meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/01/2000", "last_updated_date": "13/01/2000", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-51st-meeting" }, { "title": "Public Statement on Rapilysin (Reteplase) - Incompatibility with Heparin and Precipitation following the Reconstitution - Important New Instructions for Use", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/12/1999", "last_updated_date": "23/12/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-rapilysin-reteplase-incompatibility-heparin-precipitation-following-reconstitution-important-new-instructions-use" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 55th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/12/1999", "last_updated_date": "20/12/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-55th-plenary-meeting" }, { "title": "Public Statement on Levacetylmethadol (Orlaam) - Life Threatening Cardiac Rhythm Disorders", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/12/1999", "last_updated_date": "15/12/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-levacetylmethadol-orlaam-life-threatening-cardiac-rhythm-disorders" }, { "title": "Committee for veterinary medicinal products: 50th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/12/1999", "last_updated_date": "09/12/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-50th-meeting" }, { "title": "Twenty-fourth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "02/12/1999", "last_updated_date": "02/12/1999", "news_url": "https://www.ema.europa.eu/en/news/twenty-fourth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 54th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/11/1999", "last_updated_date": "22/11/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-54th-plenary-meeting" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 28 and 29 October 1999", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "18/11/1999", "last_updated_date": "18/11/1999", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-28-29-october-1999" }, { "title": "Committee for Veterinary Medicinal Products: 49th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary;Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/11/1999", "last_updated_date": "11/11/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-49th-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 53rd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/10/1999", "last_updated_date": "25/10/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-53rd-plenary-meeting" }, { "title": "Public Statement on Leflunomide (Arava) - Pancytopenia and Serious Skin Reactions", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/10/1999", "last_updated_date": "25/10/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-leflunomide-arava-pancytopenia-serious-skin-reactions" }, { "title": "Report on EFPIA infoday - 22 october 1999", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/10/1999", "last_updated_date": "22/10/1999", "news_url": "https://www.ema.europa.eu/en/news/report-efpia-infoday-22-october-1999" }, { "title": "Committee for veterinary medicinal products: 48th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/10/1999", "last_updated_date": "14/10/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-48th-meeting" }, { "title": "Twenty-third Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "04/10/1999", "last_updated_date": "04/10/1999", "news_url": "https://www.ema.europa.eu/en/news/twenty-third-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 52nd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/09/1999", "last_updated_date": "27/09/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-52nd-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 47th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/09/1999", "last_updated_date": "16/09/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-47th-meeting" }, { "title": "Extraordinary meeting to finalise review of Anorectic Agents", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "09/09/1999", "last_updated_date": "09/09/1999", "news_url": "https://www.ema.europa.eu/en/news/extraordinary-meeting-finalise-review-anorectic-agents" }, { "title": "Committee for veterinary medicinal products: 46th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/08/1999", "last_updated_date": "18/08/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-46th-meeting" }, { "title": "Public Statement on Sifrol, Daquiran, Mirapexin (Pramipexole) - Recommendation to Reinforce the Warningon the sudden onset of sleep", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "03/08/1999", "last_updated_date": "03/08/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-sifrol-daquiran-mirapexin-pramipexole-recommendation-reinforce-warningon-sudden-onset-sleep" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 51st plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "30/07/1999", "last_updated_date": "30/07/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-51st-plenary-meeting" }, { "title": "Public Statement onSifrol, Daquiran, Mirapexin (Pramipexole) - Sudden onset of sleep", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/07/1999", "last_updated_date": "19/07/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-onsifrol-daquiran-mirapexin-pramipexole-sudden-onset-sleep" }, { "title": "Committee for veterinary medicinal products: 45th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/07/1999", "last_updated_date": "15/07/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-45th-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 50th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/06/1999", "last_updated_date": "25/06/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-50th-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 44th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/06/1999", "last_updated_date": "18/06/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-44th-meeting" }, { "title": "Public Statement on Trovan / Trovan IV / Turvel / Turvel IV (Trovafloxacin/Alatrofloxacin) recommendation to suspend the marketing authorisation in the European Union", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/06/1999", "last_updated_date": "15/06/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-trovan-trovan-iv-turvel-turvel-iv-trovafloxacin-alatrofloxacin-recommendation-suspend-marketing-authorisation-european-union" }, { "title": "Meeting of the EMEA working party on herbal medicinal products 31 May - 1 June 1999", "press_release": "No", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "03/06/1999", "last_updated_date": "03/06/1999", "news_url": "https://www.ema.europa.eu/en/news/meeting-emea-working-party-herbal-medicinal-products-31-may-1-june-1999" }, { "title": "Twenty-second Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/06/1999", "last_updated_date": "03/06/1999", "news_url": "https://www.ema.europa.eu/en/news/twenty-second-meeting-management-board" }, { "title": "Public Statement on Trovan/Trovan IV/Turvel/Turvel IV (Trovafloxacin/Alatrofloxacin): Serious, severe and unpredictable liver injuries", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/05/1999", "last_updated_date": "25/05/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-trovan-trovan-iv-turvel-turvel-iv-trovafloxacin-alatrofloxacin-serious-severe-unpredictable-liver-injuries" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 49th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/05/1999", "last_updated_date": "25/05/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-49th-plenary-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 48th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/04/1999", "last_updated_date": "26/04/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-48th-plenary-meeting" }, { "title": "Public Statement on Viagra and Patrex", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "22/04/1999", "last_updated_date": "22/04/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-viagra-patrex" }, { "title": "Sixth EMEA/FEDESA Joint Info Day at the European Agency in London", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/04/1999", "last_updated_date": "21/04/1999", "news_url": "https://www.ema.europa.eu/en/news/sixth-emea-fedesa-joint-info-day-european-agency-london" }, { "title": "Committee for veterinary medicinal products: 42nd meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/04/1999", "last_updated_date": "15/04/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-42nd-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 47th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/03/1999", "last_updated_date": "29/03/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-47th-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 41st meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/03/1999", "last_updated_date": "18/03/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-41st-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 46th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/03/1999", "last_updated_date": "01/03/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-46th-plenary-meeting" }, { "title": "Public Statement on Trovan IV and Turvel IV", "press_release": "No", "related_medicine_referral": "", "categories": "Human", "topics": "", "news_summary": "", "first_published_date": "25/02/1999", "last_updated_date": "25/02/1999", "news_url": "https://www.ema.europa.eu/en/news/public-statement-trovan-iv-turvel-iv" }, { "title": "Committee for veterinary medicinal products: 40th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/02/1999", "last_updated_date": "18/02/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-40th-meeting" }, { "title": "Report from the ADHOC working group meeting on herbal medicinal products 1997 - 1998", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "10/02/1999", "last_updated_date": "10/02/1999", "news_url": "https://www.ema.europa.eu/en/news/report-adhoc-working-group-meeting-herbal-medicinal-products-1997-1998" }, { "title": "Twenty-First Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "10/02/1999", "last_updated_date": "10/02/1999", "news_url": "https://www.ema.europa.eu/en/news/twenty-first-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 45th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "01/02/1999", "last_updated_date": "01/02/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-45th-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 39th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/01/1999", "last_updated_date": "14/01/1999", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-39th-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 44th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/12/1998", "last_updated_date": "21/12/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-44th-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 38th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/12/1998", "last_updated_date": "11/12/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-38th-meeting" }, { "title": "Twentieth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/12/1998", "last_updated_date": "03/12/1998", "news_url": "https://www.ema.europa.eu/en/news/twentieth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 43rd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/11/1998", "last_updated_date": "24/11/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-43rd-plenary-meeting" }, { "title": "Press Release on COMTESS/COMTAN (Entacapone) - Update of Product Information", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/11/1998", "last_updated_date": "23/11/1998", "news_url": "https://www.ema.europa.eu/en/news/press-release-comtess-comtan-entacapone-update-product-information" }, { "title": "Entacapone (Comtess/Comtan) - Update of Product Information", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/11/1998", "last_updated_date": "23/11/1998", "news_url": "https://www.ema.europa.eu/en/news/entacapone-comtess-comtan-update-product-information" }, { "title": "Committee for veterinary medicinal products: 37th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/11/1998", "last_updated_date": "12/11/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-37th-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 42nd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "26/10/1998", "last_updated_date": "26/10/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-42nd-plenary-meeting" }, { "title": "Committee for veterinary medicinal products: 36th meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/10/1998", "last_updated_date": "15/10/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-veterinary-medicinal-products-36th-meeting" }, { "title": "Nineteenth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "01/10/1998", "last_updated_date": "01/10/1998", "news_url": "https://www.ema.europa.eu/en/news/nineteenth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 41st plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/09/1998", "last_updated_date": "21/09/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-41st-plenary-meeting" }, { "title": "35th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/09/1998", "last_updated_date": "10/09/1998", "news_url": "https://www.ema.europa.eu/en/news/35th-meeting-committee-veterinary-medicinal-products" }, { "title": "Public statement on supply of Norvir hard capsules", "press_release": "No", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "28/07/1998", "last_updated_date": "28/07/1998", "news_url": "https://www.ema.europa.eu/en/news/public-statement-supply-norvir-hard-capsules" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 40th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/07/1998", "last_updated_date": "27/07/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-40th-plenary-meeting" }, { "title": "34th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "09/07/1998", "last_updated_date": "09/07/1998", "news_url": "https://www.ema.europa.eu/en/news/34th-meeting-committee-veterinary-medicinal-products" }, { "title": "ADHOC working group meeting on herbal medicinal products: 6 - 7 July 1998", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "06/07/1998", "last_updated_date": "06/07/1998", "news_url": "https://www.ema.europa.eu/en/news/adhoc-working-group-meeting-herbal-medicinal-products-6-7-july-1998" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 39th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/06/1998", "last_updated_date": "29/06/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-39th-plenary-meeting" }, { "title": "33rd meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/06/1998", "last_updated_date": "11/06/1998", "news_url": "https://www.ema.europa.eu/en/news/33rd-meeting-committee-veterinary-medicinal-products" }, { "title": "Eighteenth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/06/1998", "last_updated_date": "03/06/1998", "news_url": "https://www.ema.europa.eu/en/news/eighteenth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 38th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/05/1998", "last_updated_date": "29/05/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-38th-plenary-meeting" }, { "title": "32nd meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "07/05/1998", "last_updated_date": "07/05/1998", "news_url": "https://www.ema.europa.eu/en/news/32nd-meeting-committee-veterinary-medicinal-products" }, { "title": "Statement on British Biotech Pharmaceuticals Ltd.'s ZACUTEX Application of the 5th May 1998.", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "05/05/1998", "last_updated_date": "05/05/1998", "news_url": "https://www.ema.europa.eu/en/news/statement-british-biotech-pharmaceuticals-ltds-zacutex-application-5th-may-1998" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 37th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "22/04/1998", "last_updated_date": "22/04/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-37th-plenary-meeting" }, { "title": "31st meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/04/1998", "last_updated_date": "08/04/1998", "news_url": "https://www.ema.europa.eu/en/news/31st-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 36th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/03/1998", "last_updated_date": "27/03/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-36th-plenary-meeting" }, { "title": "30th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/03/1998", "last_updated_date": "12/03/1998", "news_url": "https://www.ema.europa.eu/en/news/30th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 35th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "27/02/1998", "last_updated_date": "27/02/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-35th-plenary-meeting" }, { "title": "Seventeenth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "20/02/1998", "last_updated_date": "20/02/1998", "news_url": "https://www.ema.europa.eu/en/news/seventeenth-meeting-management-board" }, { "title": "29th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/02/1998", "last_updated_date": "12/02/1998", "news_url": "https://www.ema.europa.eu/en/news/29th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 34th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "30/01/1998", "last_updated_date": "30/01/1998", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-34th-plenary-meeting" }, { "title": "Herbal medicinal products working group: Executive summary of adhoc meetings", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal;Herbal", "topics": "", "news_summary": "", "first_published_date": "28/01/1998", "last_updated_date": "28/01/1998", "news_url": "https://www.ema.europa.eu/en/news/herbal-medicinal-products-working-group-executive-summary-adhoc-meetings" }, { "title": "28th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/01/1998", "last_updated_date": "15/01/1998", "news_url": "https://www.ema.europa.eu/en/news/28th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 33rd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/12/1997", "last_updated_date": "19/12/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-33rd-plenary-meeting" }, { "title": "27th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/12/1997", "last_updated_date": "11/12/1997", "news_url": "https://www.ema.europa.eu/en/news/27th-meeting-committee-veterinary-medicinal-products" }, { "title": "Sixteenth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/12/1997", "last_updated_date": "05/12/1997", "news_url": "https://www.ema.europa.eu/en/news/sixteenth-meeting-management-board" }, { "title": "AD HOC working group on herbal medicinal products meeting of the 24-25 November 1997", "press_release": "Yes", "related_medicine_referral": "", "categories": "Herbal", "topics": "", "news_summary": "", "first_published_date": "25/11/1997", "last_updated_date": "25/11/1997", "news_url": "https://www.ema.europa.eu/en/news/ad-hoc-working-group-herbal-medicinal-products-meeting-24-25-november-1997" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 32nd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/11/1997", "last_updated_date": "20/11/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-32nd-plenary-meeting" }, { "title": "26th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/11/1997", "last_updated_date": "13/11/1997", "news_url": "https://www.ema.europa.eu/en/news/26th-meeting-committee-veterinary-medicinal-products" }, { "title": "Workshop on transparency and access to documents of the EMEA of the 30 October 1997", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "31/10/1997", "last_updated_date": "31/10/1997", "news_url": "https://www.ema.europa.eu/en/news/workshop-transparency-access-documents-emea-30-october-1997" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 31st plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/10/1997", "last_updated_date": "24/10/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-31st-plenary-meeting" }, { "title": "25th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/10/1997", "last_updated_date": "16/10/1997", "news_url": "https://www.ema.europa.eu/en/news/25th-meeting-committee-veterinary-medicinal-products" }, { "title": "Fifteenth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/10/1997", "last_updated_date": "03/10/1997", "news_url": "https://www.ema.europa.eu/en/news/fifteenth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 30th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/09/1997", "last_updated_date": "25/09/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-30th-plenary-meeting" }, { "title": "24th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "11/09/1997", "last_updated_date": "11/09/1997", "news_url": "https://www.ema.europa.eu/en/news/24th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 29th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "25/07/1997", "last_updated_date": "25/07/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-29th-plenary-meeting" }, { "title": "23rd meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "18/07/1997", "last_updated_date": "18/07/1997", "news_url": "https://www.ema.europa.eu/en/news/23rd-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 28th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/06/1997", "last_updated_date": "20/06/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-28th-plenary-meeting" }, { "title": "22nd meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/06/1997", "last_updated_date": "13/06/1997", "news_url": "https://www.ema.europa.eu/en/news/22nd-meeting-committee-veterinary-medicinal-products" }, { "title": "Fourteenth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/06/1997", "last_updated_date": "06/06/1997", "news_url": "https://www.ema.europa.eu/en/news/fourteenth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 27th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "16/05/1997", "last_updated_date": "16/05/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-27th-plenary-meeting" }, { "title": "21st meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "08/05/1997", "last_updated_date": "08/05/1997", "news_url": "https://www.ema.europa.eu/en/news/21st-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 26th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/04/1997", "last_updated_date": "18/04/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-26th-plenary-meeting" }, { "title": "News update from veterinary unit 14 April 1997: centralised procedure for authorisation of veterinary medicinal products in the EU", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/04/1997", "last_updated_date": "14/04/1997", "news_url": "https://www.ema.europa.eu/en/news/news-update-veterinary-unit-14-april-1997-centralised-procedure-authorisation-veterinary-medicinal-products-eu" }, { "title": "20th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "10/04/1997", "last_updated_date": "10/04/1997", "news_url": "https://www.ema.europa.eu/en/news/20th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 25th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/03/1997", "last_updated_date": "21/03/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-25th-plenary-meeting" }, { "title": "19th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "14/03/1997", "last_updated_date": "14/03/1997", "news_url": "https://www.ema.europa.eu/en/news/19th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 24th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/02/1997", "last_updated_date": "20/02/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-24th-plenary-meeting" }, { "title": "Visit of IberoAmerican regulatory authorities to the Spanish Ministry of Health and Consumer Affairs (Madrid) and to the EMEA (London)", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/02/1997", "last_updated_date": "20/02/1997", "news_url": "https://www.ema.europa.eu/en/news/visit-iberoamerican-regulatory-authorities-spanish-ministry-health-consumer-affairs-madrid-emea-london" }, { "title": "18th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "12/02/1997", "last_updated_date": "12/02/1997", "news_url": "https://www.ema.europa.eu/en/news/18th-meeting-committee-veterinary-medicinal-products" }, { "title": "Thirteenth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/02/1997", "last_updated_date": "06/02/1997", "news_url": "https://www.ema.europa.eu/en/news/thirteenth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 23rd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "24/01/1997", "last_updated_date": "24/01/1997", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-23rd-plenary-meeting" }, { "title": "17th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/01/1997", "last_updated_date": "16/01/1997", "news_url": "https://www.ema.europa.eu/en/news/17th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 22nd plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/12/1996", "last_updated_date": "18/12/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-22nd-plenary-meeting" }, { "title": "16th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "13/12/1996", "last_updated_date": "13/12/1996", "news_url": "https://www.ema.europa.eu/en/news/16th-meeting-committee-veterinary-medicinal-products" }, { "title": "Twelfth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "05/12/1996", "last_updated_date": "05/12/1996", "news_url": "https://www.ema.europa.eu/en/news/twelfth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 21st plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/11/1996", "last_updated_date": "20/11/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-21st-plenary-meeting" }, { "title": "15th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "25/10/1996", "last_updated_date": "25/10/1996", "news_url": "https://www.ema.europa.eu/en/news/15th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 20th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "16/10/1996", "last_updated_date": "16/10/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-20th-plenary-meeting" }, { "title": "Eleventh Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/09/1996", "last_updated_date": "26/09/1996", "news_url": "https://www.ema.europa.eu/en/news/eleventh-meeting-management-board" }, { "title": "14th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "19/09/1996", "last_updated_date": "19/09/1996", "news_url": "https://www.ema.europa.eu/en/news/14th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 19th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "11/09/1996", "last_updated_date": "11/09/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-19th-plenary-meeting" }, { "title": "13th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "24/07/1996", "last_updated_date": "24/07/1996", "news_url": "https://www.ema.europa.eu/en/news/13th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 18th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/07/1996", "last_updated_date": "18/07/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-18th-plenary-meeting" }, { "title": "Tenth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "03/07/1996", "last_updated_date": "03/07/1996", "news_url": "https://www.ema.europa.eu/en/news/tenth-meeting-management-board" }, { "title": "12th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "27/06/1996", "last_updated_date": "27/06/1996", "news_url": "https://www.ema.europa.eu/en/news/12th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 17th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "20/06/1996", "last_updated_date": "20/06/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-17th-plenary-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 16th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "23/05/1996", "last_updated_date": "23/05/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-16th-plenary-meeting" }, { "title": "11th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "25/04/1996", "last_updated_date": "25/04/1996", "news_url": "https://www.ema.europa.eu/en/news/11th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 15th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/04/1996", "last_updated_date": "19/04/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-15th-plenary-meeting" }, { "title": "10th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "22/03/1996", "last_updated_date": "22/03/1996", "news_url": "https://www.ema.europa.eu/en/news/10th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 14th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "14/03/1996", "last_updated_date": "14/03/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-14th-plenary-meeting" }, { "title": "Ninth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "06/03/1996", "last_updated_date": "06/03/1996", "news_url": "https://www.ema.europa.eu/en/news/ninth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 13th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "15/02/1996", "last_updated_date": "15/02/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-13th-plenary-meeting" }, { "title": "9th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "07/02/1996", "last_updated_date": "07/02/1996", "news_url": "https://www.ema.europa.eu/en/news/9th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 12th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "18/01/1996", "last_updated_date": "18/01/1996", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-12th-plenary-meeting" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 11th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "21/12/1995", "last_updated_date": "21/12/1995", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-11th-plenary-meeting" }, { "title": "8th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "15/12/1995", "last_updated_date": "15/12/1995", "news_url": "https://www.ema.europa.eu/en/news/8th-meeting-committee-veterinary-medicinal-products" }, { "title": "Eighth Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "08/12/1995", "last_updated_date": "08/12/1995", "news_url": "https://www.ema.europa.eu/en/news/eighth-meeting-management-board" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 10th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "29/11/1995", "last_updated_date": "29/11/1995", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-10th-plenary-meeting" }, { "title": "7th meeting of the committee for veterinary medicinal products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Veterinary", "topics": "", "news_summary": "", "first_published_date": "16/11/1995", "last_updated_date": "16/11/1995", "news_url": "https://www.ema.europa.eu/en/news/7th-meeting-committee-veterinary-medicinal-products" }, { "title": "Committee for Proprietary Medicinal Products (CPMP) 9th plenary meeting", "press_release": "Yes", "related_medicine_referral": "", "categories": "", "topics": "", "news_summary": "", "first_published_date": "19/10/1995", "last_updated_date": "19/10/1995", "news_url": "https://www.ema.europa.eu/en/news/committee-proprietary-medicinal-products-cpmp-9th-plenary-meeting" }, { "title": "Seventh Meeting of the Management Board", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "25/09/1995", "last_updated_date": "25/09/1995", "news_url": "https://www.ema.europa.eu/en/news/seventh-meeting-management-board" }, { "title": "Sixth meeting of the Management Board of the European Agency for the Evaluation of Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "24/04/1995", "last_updated_date": "24/04/1995", "news_url": "https://www.ema.europa.eu/en/news/sixth-meeting-management-board-european-agency-evaluation-medicinal-products" }, { "title": "Fifth Meeting of the EMEA Management Board took the form of the Official Inauguration", "press_release": "No", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "26/01/1995", "last_updated_date": "26/01/1995", "news_url": "https://www.ema.europa.eu/en/news/fifth-meeting-emea-management-board-took-form-official-inauguration" }, { "title": "Fourth Meeting of the Management Board of the European Agency for the Evaluation of Medical Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "28/10/1994", "last_updated_date": "28/10/1994", "news_url": "https://www.ema.europa.eu/en/news/fourth-meeting-management-board-european-agency-evaluation-medical-products" }, { "title": "Third Meeting of the Management Board of the European Agency for the Evaluation of Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "23/06/1994", "last_updated_date": "23/06/1994", "news_url": "https://www.ema.europa.eu/en/news/third-meeting-management-board-european-agency-evaluation-medicinal-products" }, { "title": "Second Meeting of the Management Board of the European Agency for the Evaluation of Medicinal Products", "press_release": "Yes", "related_medicine_referral": "", "categories": "Corporate", "topics": "", "news_summary": "", "first_published_date": "13/04/1994", "last_updated_date": "13/04/1994", "news_url": "https://www.ema.europa.eu/en/news/second-meeting-management-board-european-agency-evaluation-medicinal-products" } ] }