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Date Content
21/04/2021 News and press releases: Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
21/04/2021 Human medicines European public assessment report (EPAR): Giotrif, afatinib, Carcinoma, Non-Small-Cell Lung, 25/09/2013, 14, Authorised (updated)
21/04/2021 COVID-19: latest updates (updated)
21/04/2021 Human medicines European public assessment report (EPAR): COVID-19 Vaccine Janssen, adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection, 11/03/2021, Additional monitoring, Conditional approval, 1, Authorised (updated)
21/04/2021 Human medicines European public assessment report (EPAR): Piqray, Alpelisib, Breast Neoplasms, 27/07/2020, Additional monitoring, 3, Authorised (updated)
21/04/2021 Agenda: Agenda - PDCO agenda of the 20-23 April 2021 meeting
21/04/2021 Veterinary Big Data stakeholder forum , Virtual event, from 01/06/2021 to 02/06/2021 (updated)
21/04/2021 Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib (s)-malate, Carcinoma, Renal Cell, 09/09/2016, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
21/04/2021 Template or form: Application form for European Medicines Agency certificates of medicinal products (updated)
21/04/2021 Periodic safety update single assessment: Gadoxetic acid disodium: List of nationally authorised medicinal products - PSUSA/00001509/202004
21/04/2021 Periodic safety update single assessment: Epirubicin: List of nationally authorised medicinal products - PSUSA/00001234/202006
21/04/2021 Periodic safety update single assessment: Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/202005
21/04/2021 Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia, 25/06/2020, Orphan, Additional monitoring, 1, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Oxcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/202008
21/04/2021 Periodic safety update single assessment: Modafinil : List of nationally authorised medicinal products - PSUSA/00010242/202008
21/04/2021 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Urologic Neoplasms, 19/06/2015, 36, Authorised (updated)
21/04/2021 Human medicines European public assessment report (EPAR): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human, 12/12/2018, Additional monitoring, 7, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Gadoteridol: List of nationally authorised medicinal products - PSUSA/00001507/202004
21/04/2021 Human medicines European public assessment report (EPAR): Samsca, Tolvaptan, Inappropriate ADH Syndrome, 02/08/2009, 14, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Gadobenic acid: List of nationally authorised medicinal products - PSUSA/00001500/202004
21/04/2021 Periodic safety update single assessment: Fluorescein (systemic use): List of nationally authorised medicinal products - PSUSA/00009153/202004
21/04/2021 Human medicines European public assessment report (EPAR): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 46, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Gadoteric acid (IV and intravascular formulations): List of nationally authorised medicinal products - PSUSA/00001506/202004
21/04/2021 Human medicines European public assessment report (EPAR): Herceptin, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 28/08/2000, 39, Authorised (updated)
21/04/2021 Periodic safety update single assessment: Porfimer: List of nationally authorised medicinal products - PSUSA/00010332/202004
21/04/2021 Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus,Dermatophagoides farinae, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/146/2011 (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Comirnaty, Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection, 21/12/2020, Additional monitoring, Conditional approval, 5, Authorised (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Conscious Sedation, 26/03/2021, Additional monitoring, Authorised
20/04/2021 Report: Minutes - PDCO minutes of the 23-26 February 2021 meeting
20/04/2021 News and press releases: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
20/04/2021 Periodic safety update single assessment: Dalteparin sodium: List of nationally authorised medicinal products - PSUSA/00000922/202008
20/04/2021 Agenda: Agenda - Veterinary Big Data Stakeholder Forum
20/04/2021 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 21, Authorised (updated)
20/04/2021 Extraordinary Management Board meeting on CTIS audit , European Medicines Agency, Amsterdam, the Netherlands, from 21/04/2021 to 21/04/2021
20/04/2021 Human medicines European public assessment report (EPAR): Vfend, voriconazole, Candidiasis, Mycoses, Aspergillosis, 19/03/2002, 48, Authorised (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, Additional monitoring, 14, Authorised (updated)
20/04/2021 Human medicines European public assessment report (EPAR): Exforge, valsartan, amlodipine (as amlodipine besilate), Hypertension, 16/01/2007, 27, Authorised (updated)
20/04/2021 Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021 , Virtual meeting, from 20/04/2021 to 20/04/2021
20/04/2021 Veterinary medicines European public assessment report (EPAR): NexGard Combo, eprinomectin, esafoxolaner, praziquantel, 06/01/2021, Authorised
20/04/2021 Human medicines European public assessment report (EPAR): Vipidia, alogliptin, Diabetes Mellitus, Type 2, 18/09/2013, 6, Authorised (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Muscular Atrophy, Spinal, 18/05/2020, Orphan, Additional monitoring, Conditional approval, 2, Authorised (updated)
19/04/2021 Newsletter: News bulletin for small and medium-sized enterprises - Issue 52
19/04/2021 Renewal and annual re-assessment of marketing authorisation (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib mesilate, Melanoma, 26/08/2013, 24, Authorised (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Lonquex, lipegfilgrastim, Neutropenia, 25/07/2013, 20, Authorised (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 21, Authorised (updated)
19/04/2021 Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia, 03/12/1998, 39, Authorised (updated)
19/04/2021 Periodic safety update single assessment: Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00001307/202007
19/04/2021 Human medicines European public assessment report (EPAR): Equidacent, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, 24/09/2020, Additional monitoring, Biosimilar, 2, Authorised (updated)
19/04/2021 Periodic safety update single assessment: Hexoprenaline sulfate: List of nationally authorised medicinal products - PSUSA/00003170/202008
19/04/2021 Other: Stakeholder engagement highlights 2020
19/04/2021 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits : Imidacloprid
19/04/2021 Maximum Residue Limits - Report: Imidacloprid (fin fish): Summary report - Committee for Veterinary Medicinal Products
19/04/2021 Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 8, Authorised (updated)
19/04/2021 Scientific recommendations on classification of advanced therapy medicinal products (updated)
19/04/2021 Other: Scientific recommendations on classification of advanced therapy medicinal products
19/04/2021 Human medicines European public assessment report (EPAR): MenQuadfi, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 18/11/2020, Additional monitoring, 1, Authorised (updated)
19/04/2021 Other: Timetable: Informed consent and multiple application (updated)
19/04/2021 Report: Medicinal products for human use: monthly figures - March 2021
19/04/2021 Agenda: Agenda - CHMP agenda of the 19-22 April 2021 meeting
16/04/2021 Human medicines European public assessment report (EPAR): Onglyza, Saxagliptin, Diabetes Mellitus, Type 2, 30/09/2009, 19, Authorised (updated)
16/04/2021 Human medicines European public assessment report (EPAR): Jinarc, Tolvaptan, Polycystic Kidney, Autosomal Dominant, 27/05/2015, Additional monitoring, 15, Authorised (updated)
16/04/2021 Press briefing on PRAC conclusions on signal of thromboembolic events with COVID-19 Vaccine Janssen , Virtual meeting, from 20/04/2021 to 20/04/2021
16/04/2021 Veterinary medicines European public assessment report (EPAR): Prevexxion RN, Live recombinant Marek’s disease (MD) virus, serotype 1, strain RN1250, 20/07/2020, Authorised
16/04/2021 Supply shortage: Shortage of Vfend (voriconazole) supply shortage
16/04/2021 Human medicines European public assessment report (EPAR): Kesimpta, ofatumumab, Multiple Sclerosis, Relapsing-Remitting, 26/03/2021, Additional monitoring, Authorised
16/04/2021 EPAR - Product Information: Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Product information (updated)
16/04/2021 Withdrawn application: Tibsovo, ivosidenib, Date of withdrawal: 13/10/2020, Initial authorisation (updated)
16/04/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
16/04/2021 Overview of comments: Allergen for therapy: Dermatophagoides pteronyssinus / Dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure): List of nationally authorised medicinal products - PSUSA/00010582/202009
16/04/2021 Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 24, Authorised (updated)
16/04/2021 Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), ChAdOx1-SARS-COV-2, COVID-19 virus infection, 29/01/2021, Additional monitoring, Conditional approval, 5, Authorised (updated)
16/04/2021 Pre-authorisation guidance (updated)
16/04/2021 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
16/04/2021 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
16/04/2021 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
16/04/2021 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
16/04/2021 Changing the labelling and package leaflet (Article 61(3) notifications) (updated)
16/04/2021 Transfer of marketing authorisation: questions and answers (updated)
16/04/2021 Periodic safety update reports (PSURs) (updated)
16/04/2021 Post-authorisation measures: questions and answers (updated)
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 April 2021
16/04/2021 COVID-19 vaccines: authorised (updated)
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 14 April 2021
16/04/2021 Herbal medicinal product: Hyperici herba, Hyperici herba, P: Draft published (updated)
16/04/2021 Grouping of variations: questions and answers (updated)
16/04/2021 Worksharing: questions and answers (updated)
16/04/2021 Extensions of marketing authorisations: questions and answers (updated)
16/04/2021 Type-II variations: questions and answers (updated)
16/04/2021 Type-IA variations: questions and answers (updated)
16/04/2021 Type-IB variations: questions and answers (updated)
16/04/2021 Post-authorisation safety studies (PASS) (updated)
16/04/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 April 2021
16/04/2021 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Trigonella foenum-graecum L., semen - Revision 1
16/04/2021 Herbal - HMPC assessment report: Draft Assessment report on Trigonella foenum-graecum L., semen - Revision 1
16/04/2021 Herbal medicinal product: Trigonellae foenugraeci semen, Trigonellae foenugraeci semen, F: Assessment finalised (updated)
15/04/2021 Veterinary medicines European public assessment report (EPAR): Prevexxion RN+HVT+IBD, Live recombinant Marek’s disease virus, serotype 1, strain RN1250; Live recombinant turkey herpesvirus, expressing the VP2 protein of infectious bursal disease virus, strain vHVT013-69, 20/07/2020, Authorised
15/04/2021 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 16, Authorised (updated)
15/04/2021 Regulatory and procedural guideline: IRIS guide to registration (updated)
15/04/2021 Periodic safety update single assessment: Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/202008
15/04/2021 COVID-19 vaccines: Article 5(3) reviews (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Zometa, zoledronic acid, zoledronic acid monohydrate, Cancer, Fractures, Bone, 20/03/2001, 35, Authorised (updated)
15/04/2021 Periodic safety update single assessment: Ethinylestradiol / etonogestrel: List of nationally authorised medicinal products - PSUSA/00001307/202007
15/04/2021 Periodic safety update single assessment: Ethinylestradiol / etonogestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001307/202007
15/04/2021 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 22, Authorised (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Oyavas, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 26/03/2021, Additional monitoring, Biosimilar, Authorised
15/04/2021 Orphan designation: Somapacitan for the: Treatment of growth hormone deficiency, 24/08/2018, Positive (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Sogroya, Somapacitan, Growth, 31/03/2021, Orphan, Authorised
15/04/2021 News and press releases: EMA starts review of VIR-7831 for treating patients with COVID-19
15/04/2021 Periodic safety update single assessment: Octreotide: List of nationally authorised medicinal products - PSUSA/00002201/202006
15/04/2021 Periodic safety update single assessment: Octreotide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002201/202006
15/04/2021 Joint HMA/EMA workshop on artificial intelligence in medicines regulation , Virtual event, from 19/04/2021 to 20/04/2021 (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, 17/03/2011, 19, Authorised (updated)
15/04/2021 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 13, Authorised (updated)
15/04/2021 Direct healthcare professional communication (DHPC): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe, Active substance: aflibercept, DHPC type: Adverse event, Last updated: 15/04/2021
15/04/2021 Periodic safety update single assessment: Nifedipine: List of nationally authorised medicinal products - PSUSA/00002156/202008
15/04/2021 Report: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive
15/04/2021 Paediatric investigation plans (updated)
15/04/2021 Other: Common Commentary - EMA/FDA: Common issues requested for discussion by the respective agency (EMA/PDCO and FDA) concerning paediatric oncology development plans (Paediatric Investigation Plans [PIPs] and initial Pediatric Study Plans [iPSPs])
14/04/2021 European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021 , Virtual meeting, from 25/03/2021 to 25/03/2021 (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Vazkepa, Icosapent ethyl, Dyslipidemias, 26/03/2021, Authorised
14/04/2021 Agenda: Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course (2021) (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms, Sarcoma, 17/09/2007, 26, Authorised (updated)
14/04/2021 Referrals document: Letter from Commissioner Kyriakides asking EMA to follow up on Vaxzevria opinion after Council discussion
14/04/2021 News and press releases: AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
14/04/2021 COVID-19 vaccines (updated)
14/04/2021 Article 5(3) opinions (updated)
14/04/2021 Other: Article 57 product data (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 28, Authorised (updated)
14/04/2021 Periodic safety update single assessment: Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/202008
14/04/2021 Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms, Stomach Neoplasms, 27/07/2020, Additional monitoring, Biosimilar, 3, Authorised (updated)
14/04/2021 Human medicines European public assessment report (EPAR): PecFent, fentanyl, Pain, Cancer, 31/08/2010, 20, Authorised (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 9, Authorised (updated)
14/04/2021 News and press releases: COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
14/04/2021 Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, Additional monitoring, 5, Authorised (updated)
14/04/2021 News and press releases: IT systems intermittently unavailable from 16 to 18 April 2021
14/04/2021 Veterinary medicines European public assessment report (EPAR): Enteroporc Coli, Inactivated fimbrial adhesins of Escherichia coli F4ab, Inactivated fimbrial adhesins of Escherichia coli F4ac, Inactivated fimbrial adhesins of Escherichia coli F5, Inactivated fimbrial adhesins of Escherichia coli F6, 06/01/2021, Authorised
14/04/2021 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2021
14/04/2021 Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets (updated)
14/04/2021 Periodic safety update single assessment: Pefloxacin: List of nationally authorised medicinal products - PSUSA/00002322/202008
14/04/2021 Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 13/02/2020, Generic, 1, Authorised (updated)
14/04/2021 Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain, Cancer, 04/04/2008, 23, Authorised (updated)
14/04/2021 Human medicines European public assessment report (EPAR): BroPair Spiromax, salmeterol xinafoate, fluticasone propionate, Asthma, 26/03/2021, Authorised
14/04/2021 Overview of comments: Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’
14/04/2021 Agenda: Agenda - CAT agenda of the 14-16 April 2021 meeting
14/04/2021 Agenda: Programme and registration form - Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System (updated)
14/04/2021 Agenda: Agenda - Technical workshop on real-world metadata for regulatory purposes (updated)
14/04/2021 Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU , Virtual meeting, 13:00 - 15:15 (CET), from 26/03/2021 to 26/03/2021 (updated)
14/04/2021 Newsletter: Human medicines highlights - April 2021
13/04/2021 Human medicines European public assessment report (EPAR): Seffalair Spiromax, fluticasone propionate, salmeterol xinafoate, Asthma, 26/03/2021, Authorised
13/04/2021 Human medicines European public assessment report (EPAR): Ontozry, cenobamate, Epilepsy, 26/03/2021, Additional monitoring, Authorised
13/04/2021 Human medicines European public assessment report (EPAR): Rukobia, fostemsavir trometamol, HIV Infections, 04/02/2021, Additional monitoring, 1, Authorised (updated)
13/04/2021 Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), Tobramycin, Respiratory Tract Infections, Cystic Fibrosis, 18/02/2019, 3, Authorised (updated)
13/04/2021 Template or form: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based data collection form (updated)
13/04/2021 Other: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based sales and and animal population data collection protocol (updated)
13/04/2021 European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
13/04/2021 PRAC recommendation on signal: Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant]) – Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (Other viral vaccines)
13/04/2021 Committee for Orphan Medicinal Products (COMP): 13-15 April 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 13/04/2021 to 15/04/2021 (updated)
13/04/2021 Agenda: Agenda - COMP agenda of the 13-15 April 2021 meeting
13/04/2021 Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia, Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021
13/04/2021 Agenda: Agenda - CVMP agenda of the 13-15 March 2021 meeting
13/04/2021 Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload, beta-Thalassemia, 26/09/2019, Generic, 4, Authorised (updated)
13/04/2021 Human medicines European public assessment report (EPAR): Beromun, tasonermin, Sarcoma, 12/04/1999, 14, Authorised (updated)
13/04/2021 Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 42, Authorised (updated)
12/04/2021 Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 21, Authorised (updated)
12/04/2021 Work programme: Nitrosamine Implementation Oversight Group Terms of Reference
12/04/2021 Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry , from 31/03/2021 to 31/03/2021 (updated)
12/04/2021 Nitrosamine Implementation Oversight Group (NIOG) - Kick-off meeting , from 10/03/2021 to 10/03/2021
12/04/2021 Nitrosamine impurities (updated)
12/04/2021 Orphan designation: Ribavirin for the: Treatment of Lassa fever, 21/02/2018, Positive (updated)
12/04/2021 Orphan designation: Ribavirin for the: Treatment of Crimean-Congo haemorrhagic fever, 21/03/2018, Positive (updated)
12/04/2021 Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, 14/01/2019, Additional monitoring, 3, Authorised (updated)
12/04/2021 Clinical Trials Information System (CTIS): training programme (updated)
12/04/2021 Human medicines European public assessment report (EPAR): Ixiaro, Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese, Immunization, 31/03/2009, 17, Authorised (updated)
12/04/2021 Veterinary medicines European public assessment report (EPAR): Leucofeligen FeLV/RCP, purified p45 feline leukaemia virus envelope antigen, live feline calicivirus (strain F9), live feline viral rhinotracheitis virus (strain F2), live feline panleucopenia virus, 24/06/2009, 8, Authorised (updated)
09/04/2021 Compliance: Overview (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, Generic, 9, Authorised (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Zoledronic acid Mylan, zoledronic acid, Fractures, Bone, 23/08/2012, Generic, 11, Authorised (updated)
09/04/2021 Orphan designation: Ixazomib for the: Treatment of systemic light chain amyloidosis, 08/11/2012, Withdrawn (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Jentadueto, linagliptin, metformin, Diabetes Mellitus, Type 2, 19/07/2012, 19, Authorised (updated)
09/04/2021 Webinar on reporting suspected side effects following administration of veterinary medicines , Virtual meeting, from 30/03/2021 to 30/03/2021 (updated)
09/04/2021 Report: Hearing with the Association of the European Self-Medication Industry (AESGP) during the HMPC November 2020 meeting
09/04/2021 Interested Parties to the HMPC (updated)
09/04/2021 Agenda: Programme and registration form - Risk management information day 2021
09/04/2021 Risk management information day 2021 , Virtual meeting, from 15/06/2021 to 15/06/2021
09/04/2021 Other: Nullification ICSRs received by EudraVigilance (updated)
09/04/2021 Technical workshop on real-world metadata for regulatory purposes , Virtual meeting, from 12/04/2021 to 12/04/2021 (updated)
09/04/2021 Other: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP) (updated)
09/04/2021 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
09/04/2021 Human medicines European public assessment report (EPAR): Coagadex, Human coagulation factor X, Factor X Deficiency, 16/03/2016, Orphan, Accelerated assessment, Additional monitoring, 7, Authorised (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Opsumit, Macitentan, Hypertension, Pulmonary, 20/12/2013, Orphan, 17, Authorised (updated)
09/04/2021 Orphan designation: Adeno-associated viral vector serotype 9 containing the human cardiac calsequestrin gene for the: Treatment of catecholaminergic polymorphic ventricular tachycardia, 29/07/2014, Positive (updated)
09/04/2021 Herbal medicinal product: Cinnamomi cortex, Cinnamomi cortex, F: Assessment finalised (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Trimbow, Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 17/07/2017, 5, Authorised (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Dovprela (previously Pretomanid FGK), Pretomanid, Tuberculosis, Multidrug-Resistant, 31/07/2020, Orphan, Additional monitoring, Conditional approval, 3, Authorised (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 6, Authorised (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, 13, Authorised (updated)
09/04/2021 Orphan designation: Radio-iodinated (131I) anti-CD45 murine monoclonal antibody for the: Treatment in haematopoietic stem cell transplantation, 14/10/2016, Positive (updated)
09/04/2021 Human medicines European public assessment report (EPAR): Rubraca, rucaparib camsylate, Ovarian Neoplasms, 23/05/2018, Additional monitoring, Conditional approval, 6, Authorised (updated)
08/04/2021 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia, Bipolar Disorder, 12/12/2007, Generic, 28, Authorised (updated)
08/04/2021 Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, 30/05/2017, Orphan, Accelerated assessment, Additional monitoring, Exceptional circumstances, 5, Authorised (updated)
08/04/2021 Human medicines European public assessment report (EPAR): Xromi, hydroxycarbamide, Anemia, Sickle Cell, 01/07/2019, Authorised (updated)
08/04/2021 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 08/02/2018, Generic, 6, Authorised (updated)
08/04/2021 Plasma master file certificates (updated)
08/04/2021 Orphan designation: Chimeric monoclonal antibody against claudin 6 for the: Treatment of ovarian cancer, 24/01/2013, Withdrawn (updated)
08/04/2021 Human medicines European public assessment report (EPAR): Pegasys, peginterferon alfa-2a, Hepatitis C, Chronic, Hepatitis B, Chronic, 20/06/2002, 42, Authorised (updated)
08/04/2021 Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy, Anxiety Disorders, Neuralgia, 05/07/2004, 49, Authorised (updated)
08/04/2021 Human medicines European public assessment report (EPAR): Cubicin, daptomycin, Gram-Positive Bacterial Infections, Bacteremia, Soft Tissue Infections, Endocarditis, Bacterial, 19/01/2006, 35, Authorised (updated)
08/04/2021 Veterinary medicines European public assessment report (EPAR): Syvazul BTV, Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004, Inactivated bluetongue virus, serotype 8, strain BEL2006/01, 09/01/2019, 2, Authorised (updated)
08/04/2021 Other: HMPC: overview of assessment work - priority list (updated)
07/04/2021 Human medicines European public assessment report (EPAR): Doptelet, avatrombopag maleate, Thrombocytopenia, 20/06/2019, Additional monitoring, 4, Authorised (updated)
07/04/2021 Periodic safety update single assessment: Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/202007
07/04/2021 Periodic safety update single assessment: Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010390/202007
07/04/2021 Human medicines European public assessment report (EPAR): Kymriah, tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, 22/08/2018, Orphan, Additional monitoring, 4, Authorised (updated)
07/04/2021 Periodic safety update single assessment: Primidone: List of nationally authorised medicinal products - PSUSA/00002525/202006
07/04/2021 Periodic safety update single assessment: Primidone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002525/202006
07/04/2021 Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, Additional monitoring, Conditional approval, 6, Authorised (updated)
07/04/2021 News and press releases: AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
07/04/2021 Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, 14/01/2015, Additional monitoring, 11, Authorised (updated)
07/04/2021 Human medicines European public assessment report (EPAR): Vaxchora, vibrio cholerae, strain cvd 103-hgr, live, Cholera, 01/04/2020, Additional monitoring, 2, Authorised (updated)
07/04/2021 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 30, Authorised (updated)
07/04/2021 Orphan designation: Recombinant human glutamate oxaloacetate transaminase 1 for the: Treatment of glioma, 12/02/2015, Withdrawn (updated)
07/04/2021 Human medicines European public assessment report (EPAR): Competact, pioglitazone, metformin hydrochloride, Diabetes Mellitus, Type 2, 28/07/2006, 19, Authorised (updated)
07/04/2021 Other: Records of data processing activity for the handling the contribution towards commuting costs (public)
07/04/2021 Orphan designation: Allogeneic multi-virus specific T lymphocytes targeting BK virus, cytomegalovirus, human herpesvirus-6, Epstein Barr virus and adenovirus for the: Treatment in haematopoietic stem cell transplantation, 24/03/2020, Positive (updated)
07/04/2021 Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol, Mometasone furoate, Asthma, 30/05/2020, 1, Authorised (updated)
07/04/2021 Change management for the EudraVigilance system (updated)
07/04/2021 Regulatory and procedural guideline: European Union individual case safety report (ICSR) implementation guide (updated)
07/04/2021 Regulatory and procedural guideline: EU reference instances (EDQM revision)
07/04/2021 Regulatory and procedural guideline: EU E2B (R3) testing files (EDQM revision)
07/04/2021 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Accelerated assessment, Additional monitoring, 13, Authorised (updated)
07/04/2021 Press briefing on the conclusion of the assessment of the Pharmacovigilance Risk Assessment Committee (PRAC) of Vaxzevria (previously COVID-19 Vaccine AstraZeneca) and thromboembolic events , Virtual meeting, from 07/04/2021 to 07/04/2021
07/04/2021 Herbal medicinal product: Tiliae flos , Tiliae flos, C: ongoing call for scientific data (updated)
07/04/2021 Herbal medicinal product: Salviae miltiorrhizae rhizoma, Salviae miltiorrhizae rhizoma, F: Assessment finalised (updated)
07/04/2021 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
07/04/2021 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
07/04/2021 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
07/04/2021 Herbal medicinal product: Origani dictamni herba, Origani dictamni herba, C: ongoing call for scientific data (updated)
07/04/2021 Herbal medicinal product: Paulliniae semen, Paulliniae semen, C: ongoing call for scientific data (updated)
07/04/2021 Herbal medicinal product: Rhodiolae roseae rhizoma et radix, Rhodiolae roseae rhizoma et radix, C: ongoing call for scientific data (updated)
07/04/2021 Herbal medicinal product: Urticae radix, Urticae radix, C: ongoing call for scientific data (updated)
07/04/2021 Herbal medicinal product: Liquiritiae radix, Liquiritiae radix, C: ongoing call for scientific data (updated)
07/04/2021 Herbal medicinal product: Lichen islandicus, Lichen islandicus, C: ongoing call for scientific data (updated)
07/04/2021 Herbal medicinal product: Millefolii herba, Millefolii herba, F: Assessment finalised (updated)
07/04/2021 Herbal medicinal product: Aloysiae folium, Aloysiae citriodorae folium, F: Assessment finalised (updated)
07/04/2021 Herbal medicinal product: Menthae piperitae aetheroleum, Menthae piperitae aetheroleum, F: Assessment finalised (updated)
07/04/2021 Herbal medicinal product: Menthae piperitae folium, Menthae piperitae folium, F: Assessment finalised (updated)
07/04/2021 Herbal medicinal product: Marrubii herba, Marrubii herba, C: ongoing call for scientific data (updated)
07/04/2021 Orphan designation: Synthetic 12 amino acid peptide designed after subcommissural organ-spondin for the: Treatment of spinal cord injury, 13/11/2013, Positive (updated)