What's new

RSS
Date Content
22/12/2022 Quarterly system demo - Q4 2022 , Online, 09:00 - 12:00 Amsterdam time (CET), from 21/12/2022 to 21/12/2022
22/12/2022 Human medicines European public assessment report (EPAR): Rizmoic, Naldemedine tosilate, Constipation, 18/02/2019, Additional monitoring, 7, Authorised
22/12/2022 Other: Clinical Trial Information System (CTIS) - Sponsor handbook
22/12/2022 Other: Questions and answers - Quarterly system demo - Q4 2022
22/12/2022 Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus, 31/07/2013, Additional monitoring, Exceptional circumstances, 23, Authorised
22/12/2022 Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis, Additional monitoring, Authorised
22/12/2022 Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, 25/07/2008, 21, Authorised
22/12/2022 Newsletter: CTIS newsflash - 12 December 2022
22/12/2022 Newsletter: CTIS newsflash - 5 December 2022
22/12/2022 Human medicines European public assessment report (EPAR): Posaconazole AHCL, posaconazole, Mycoses, 25/07/2019, Generic, 5, Authorised
22/12/2022 Other: European Medicines Agency's Data Protection notice concerning the Veterinary Info Day meeting on 16-17 February 2023
22/12/2022 Orphan designation: Pegylated adrenomedullin for the: Treatment of acute respiratory distress syndrome (ARDS), 27/07/2020, Positive
22/12/2022 Orphan designation: Human allogeneic bone-marrow-derived osteoblastic-like cells for the: Treatment of non-traumatic osteonecrosis, 05/08/2013, Positive
22/12/2022 Orphan designation: Human allogeneic bone-marrow-derived osteoblastic cells for the: Treatment of osteogenesis imperfecta, 10/08/2015, Positive
22/12/2022 Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Cystic Fibrosis; Respiratory Tract Infections, 25/03/2015, Additional monitoring, 15, Authorised
22/12/2022 Human medicines European public assessment report (EPAR): Mycapssa, Octreotide acetate, Acromegaly, 02/12/2022, Orphan, Authorised
22/12/2022 Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Clostridium Infections, 05/12/2011, 17, Authorised
22/12/2022 Opinion on medicine for use outside EU: Fexinidazole Winthrop, fexinidazole, Trypanosomiasis, African, 15/11/2018, Positive opinion
22/12/2022 Human medicines European public assessment report (EPAR): Hepcludex, Bulevirtide acetate, Hepatitis D, Chronic, 31/07/2020, Orphan, Additional monitoring, Conditional approval, 8, Authorised
22/12/2022 Human medicines European public assessment report (EPAR): Exjade, deferasirox, beta-Thalassemia; Iron Overload, 28/08/2006, Additional monitoring, 51, Authorised
22/12/2022 Human medicines European public assessment report (EPAR): Esperoct, Turoctocog alfa pegol, Hemophilia A, 20/06/2019, Additional monitoring, 4, Authorised
22/12/2022 Human medicines European public assessment report (EPAR): Vipidia, alogliptin, Diabetes Mellitus, Type 2, 18/09/2013, 9, Authorised
22/12/2022 Opinion/decision on a Paediatric investigation plan (PIP): Rivogenlecleucel, PM: decision on the application for modification of an agreed PIP, P/0378/2019
22/12/2022 Human medicines European public assessment report (EPAR): Opsumit, Macitentan, Hypertension, Pulmonary, 20/12/2013, Orphan, 21, Authorised
22/12/2022 Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, benralizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0388/2021
22/12/2022 Opinion/decision on a Paediatric investigation plan (PIP): Pradigastat, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0120/2014
22/12/2022 Human variations electronic application form (eAF) Q&A clinics – session 7 , Online, 11:30 - 12:00 Amsterdam time (CET), from 24/01/2023 to 24/01/2023
22/12/2022 Agenda: Agenda - Human variations electronic application form (eAF) Q&A clinics – session 6
22/12/2022 Human variations electronic application form (eAF) Q&A clinics – session 6 , Online, 15:30 - 16:00 Amsterdam time (CET), from 17/01/2023 to 17/01/2023
21/12/2022 Cancer Medicines Forum December 2022 , Online, from 20/12/2022 to 20/12/2022
21/12/2022 Union Product Database
21/12/2022 Human medicines European public assessment report (EPAR): Ronapreve, casirivimab, imdevimab, COVID-19 virus infection, 12/11/2021, Additional monitoring, 2, Authorised
21/12/2022 Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
21/12/2022 Ninth Nitrosamine Implementation Oversight Group (NIOG) meeting , Online, from 21/11/2022 to 21/11/2022
21/12/2022 Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Radionuclide Imaging; Alzheimer Disease, 22/08/2014, 14, Authorised
21/12/2022 Human medicines European public assessment report (EPAR): Zaltrap, aflibercept, Colorectal Neoplasms, 01/02/2013, 13, Authorised
21/12/2022 Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty; Venous Thromboembolism, 18/05/2011, 31, Authorised
21/12/2022 Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary, 01/10/2008, 15, Authorised
21/12/2022 Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 November 2022, edition 8)
21/12/2022 Human medicines European public assessment report (EPAR): Exforge HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 15/10/2009, 23, Authorised
21/12/2022 Human medicines European public assessment report (EPAR): Abecma, idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases, 18/08/2021, Orphan, Additional monitoring, Conditional approval, 5, Authorised
21/12/2022 Minutes: Minutes of the CAT meeting 3-4 November 2022
21/12/2022 News and press releases: End-of-year message from EMA’s Executive Director
21/12/2022 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 12-15 December 2022
21/12/2022 Newsletter: Clinical Trials Highlights - December 2022
21/12/2022 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
21/12/2022 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
21/12/2022 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
21/12/2022 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
20/12/2022 Newsletter: Medicinal products for human use: monthly figures - November 2022
20/12/2022 Human medicines European public assessment report (EPAR): Dafiro HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 03/11/2009, 25, Authorised
20/12/2022 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 23, Authorised
20/12/2022 Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR) , Online, 16:30 - 18:00 Amsterdam time (CET) (Updated), from 15/12/2022 to 15/12/2022
20/12/2022 Website outages and upgrades
20/12/2022 Periodic safety update single assessment: Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/202204
20/12/2022 Periodic safety update single assessment: Oxycodone : List of nationally authorised medicinal products - PSUSA/00002254/202204
20/12/2022 Orphan designation: regorafenib for the: Treatment of glioma, 28/06/2019, Withdrawn
20/12/2022 Orphan designation: Allogeneic retinal pigment epithelial cells genetically modified with a non-viral vector to express human alpha-L-iduronidase for the: Treatment of mucopolysaccharidosis type I, 15/10/2021, Withdrawn
20/12/2022 Human medicines European public assessment report (EPAR): Retsevmo, Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms, 11/02/2021, Additional monitoring, Conditional approval, 5, Authorised
20/12/2022 Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe, olanzapine, Schizophrenia; Bipolar Disorder, 03/12/2009, Generic, 14, Authorised
20/12/2022 Human medicines European public assessment report (EPAR): Olanzapine Glenmark, olanzapine, Schizophrenia; Bipolar Disorder, 03/12/2009, Generic, 15, Authorised
20/12/2022 Human medicines European public assessment report (EPAR): Fasturtec, rasburicase, Hyperuricemia, 23/02/2001, 29, Authorised
20/12/2022 First European Medicines Agency - Vaccines Europe meeting , European Medicines Agency, Amsterdam, The Netherlands, from 28/11/2022 to 28/11/2022
20/12/2022 News and press releases: EMA business hours over holiday period
20/12/2022 Direct healthcare professional communication (DHPC): Terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS), Active substance: terlipressin, DHPC type: Change in dosing recommendation, Last updated: 20/12/2022
19/12/2022 Orphan designation: bevacizumab for the: Treatment of hereditary haemorrhagic telangiectasia, 16/12/2014, Positive
19/12/2022 Other: Release notes - production release version 1.6.13 December 2022 - Veterinary Medicinal Products Regulation: Union Product Database
19/12/2022 Human medicines European public assessment report (EPAR): Bemfola, follitropin alfa, Anovulation, 26/03/2014, Biosimilar, 10, Authorised
19/12/2022 Other: Recommended due dates for centrally authorised products (CAPs) and non-CAPs for submission of the annual statement: January 2023
19/12/2022 Accelerating Clinical Trials in the EU (ACT EU)
19/12/2022 News and press releases: Facilitating Decentralised Clinical Trials in the EU
19/12/2022 CHMP opinions on consultation procedures
19/12/2022 Other: FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation
19/12/2022 Human medicines European public assessment report (EPAR): Jemperli, dostarlimab, Endometrial Neoplasms, 21/04/2021, Additional monitoring, Conditional approval, 6, Authorised
19/12/2022 Human medicines European public assessment report (EPAR): Simbrinza, brinzolamide, brimonidine tartrate, Ocular Hypertension; Glaucoma, Open-Angle, 18/07/2014, 10, Authorised
19/12/2022 Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, Generic, 7, Authorised
19/12/2022 Human medicines European public assessment report (EPAR): Axumin, Fluciclovine (18F), Prostatic Neoplasms; Radionuclide Imaging, 21/05/2017, 16, Authorised
19/12/2022 Human medicines European public assessment report (EPAR): Shingrix, Recombinant varicella zoster virus glycoprotein E, Herpes Zoster, 21/03/2018, 9, Authorised
19/12/2022 Patients' and Consumers' Working Party
19/12/2022 Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline
19/12/2022 Scientific guideline: Concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products
16/12/2022 Other: Letter of Support of model-based clinical trial simulation platform (CTSP) for Duchenne Muscular Dystrophy
16/12/2022 News and press releases: EMA Management Board: highlights of December 2022 meeting
16/12/2022 Summary of product characteristics for antiparasitic veterinary medicinal products - Scientific guideline
16/12/2022 Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Waldenstrom Macroglobulinemia, 22/11/2021, Additional monitoring, 4, Authorised
16/12/2022 Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Arthritis, Rheumatoid, 08/09/2003, 89, Authorised
16/12/2022 Referral: Synchron , Article 31 referrals, European Commission final decision, 19/05/2022, 28/11/2022, 16/12/2022
16/12/2022 Work programme: Work plan for the CVMP Novel Therapies & Technologies Working Party (NTWP) 2023
16/12/2022 Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Soft Tissue Infections; Skin Diseases, Bacterial, 23/03/2015, 20, Authorised
16/12/2022 Opinions and letters of support on the qualification of novel methodologies for medicine development
16/12/2022 Environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs
16/12/2022 Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Environmental Risk Assessment Working Party (ERAWP) 2023
16/12/2022 Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Efficacy Working Party (EWP-V) 2023
16/12/2022 Scientific guideline: Reflection paper on the environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs
16/12/2022 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
16/12/2022 Summary of opinion: Dimethyl fumarate Accord, dimethyl fumarate, 15/12/2022, Positive
16/12/2022 Summary of opinion: Imjudo, tremelimumab, 15/12/2022, Positive
16/12/2022 Withdrawn application: Imbarkyd, bardoxolone methyl, Date of withdrawal: 09/11/2022, Initial authorisation
16/12/2022 Summary of opinion: Omblastys, iodine (131I) omburtamab, 15/12/2022, Negative
16/12/2022 Summary of opinion: Edistride, dapagliflozin, 15/12/2022, Positive
16/12/2022 Referral: Rambis and associated names , ramipril, bisoprolol fumarate, Ralbior, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 15/12/2022
16/12/2022 Summary of opinion: Forxiga, dapagliflozin, 15/12/2022, Positive
16/12/2022 Summary of opinion: Tremelimumab AstraZeneca, tremelimumab, 15/12/2022, Positive
16/12/2022 Referral: Pholcodine-containing medicinal products , pholcodine, Article 107i procedures, CMDh position, 14/12/2022, 16/12/2022
16/12/2022 Summary of opinion: Dupixent, dupilumab, 15/12/2022, Positive
16/12/2022 News and press releases: First gene therapy to treat haemophilia B
16/12/2022 Summary of opinion: Hemgenix, etranacogene dezaparvovec, 15/12/2022, Positive
16/12/2022 Summary of opinion: Pombiliti, cipaglucosidase alfa, 15/12/2022, Positive
16/12/2022 Summary of opinion: Fintepla, fenfluramine, 15/12/2022, Positive
16/12/2022 Summary of opinion: Imfinzi, durvalumab, 15/12/2022, Positive
16/12/2022 Summary of opinion: Triumeq, abacavir sulfate / dolutegravir sodium / lamivudine, 15/12/2022, Positive
16/12/2022 Summary of opinion: Imfinzi, durvalumab, 15/12/2022, Positive
16/12/2022 Summary of opinion: Hemlibra, emicizumab, 15/12/2022, Positive
16/12/2022 Summary of opinion: Adcirca (previously Tadalafil Lilly), tadalafil, 16/12/2022, Positive
16/12/2022 Referral: Gelisia and associated names , timolol maleate, Genoptol,Gelisia,Timolol sifi 1 mg/g gel oftalmico, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 15/12/2022
16/12/2022 Summary of opinion: Kerendia, finerenone, 15/12/2022, Positive
16/12/2022 Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor (axicabtagene ciloleucel) for the: Treatment of diffuse large B-cell lymphoma, 16/12/2014, Positive
16/12/2022 Human medicines European public assessment report (EPAR): Emadine, emedastine difumarate, Conjunctivitis, Allergic, 27/01/1999, 26, Authorised
16/12/2022 Human medicines European public assessment report (EPAR): Ammonaps, Sodium phenylbutyrate, Ornithine Carbamoyltransferase Deficiency Disease; Citrullinemia; Carbamoyl-Phosphate Synthase I Deficiency Disease, 07/12/1999, 21, Authorised
16/12/2022 Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Scientific Advice Working Party (SAWP-V) for 2023
16/12/2022 Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Antimicrobials Working Party (AWP) 2023
16/12/2022 Human medicines European public assessment report (EPAR): Zoely, Nomegestrol acetate, estradiol, Contraception, 26/07/2011, 22, Authorised
16/12/2022 Human medicines European public assessment report (EPAR): Refixia, Nonacog beta pegol, Hemophilia B, 02/06/2017, Additional monitoring, 3, Authorised
16/12/2022 Work programme: CVMP work plan 2023
16/12/2022 Liposomal amphotericin B product-specific bioequivalence guidance
16/12/2022 Scientific guideline: Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance
16/12/2022 Scientific guideline: Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg productspecific bioequivalence guidance
16/12/2022 Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product-specific bioequivalence guidance
16/12/2022 Agenda: Agenda - Quarterly system demo - Q4 2022
16/12/2022 Work programme: Work plan for the Committee for Medicinal Products for Veterinary Use (CVMP) Pharmacovigilance Working Party (PhVWP-V) 2023
16/12/2022 Q&A: Good clinical practice (GCP)
16/12/2022 Clinical pharmacology and pharmacokinetics: questions and answers
16/12/2022 Other: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2022
15/12/2022 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight, 26/03/2015, Additional monitoring, 23, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, Methemoglobinemia, 06/05/2011, 25, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Steglujan, ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2, 23/03/2018, 9, Authorised
15/12/2022 Other: Science advice on medicines for Human use in the EU medicines regulatory network
15/12/2022 Human medicines European public assessment report (EPAR): Cubicin, daptomycin, Gram-Positive Bacterial Infections; Bacteremia; Soft Tissue Infections; Endocarditis, Bacterial, 19/01/2006, 37, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD), caspofungin (as acetate), Candidiasis; Aspergillosis, 23/10/2001, 30, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Komboglyze, metformin hydrochloride, saxagliptin hydrochloride, Diabetes Mellitus, Type 2, 24/11/2011, 19, Authorised
15/12/2022 Human variations electronic application forms public training , Online, 10:00 - 11:30 Amsterdam time (CET), from 15/12/2022 to 15/12/2022
15/12/2022 Human medicines European public assessment report (EPAR): Onglyza, Saxagliptin, Diabetes Mellitus, Type 2, 30/09/2009, 21, Authorised
15/12/2022 Ninth industry stakeholder platform on research and development support , Online, from 05/12/2022 to 05/12/2022
15/12/2022 Third Industry Standing Group (ISG) meeting , Online, from 22/11/2022 to 22/11/2022
15/12/2022 Minutes: Meeting summary - Third Industry Standing Group (ISG) meeting
15/12/2022 Human medicines European public assessment report (EPAR): Anagrelide Mylan, Anagrelide hydrochloride, Thrombocythemia, Essential, 15/02/2018, Generic, 6, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Qtern, Saxagliptin, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Diabetes Mellitus; Nutritional and Metabolic Diseases; Metabolic Diseases; Glucose Metabolism Disorders, 15/07/2016, 10, Authorised
15/12/2022 EPAR - Scientific conclusion: Alymsys-H-C-PSUSA-00000403-202202 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
15/12/2022 Human medicines European public assessment report (EPAR): Aybintio, bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms, 19/08/2020, Additional monitoring, Biosimilar, 6, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 29, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Mucopolysaccharidosis II, 08/01/2007, Additional monitoring, Exceptional circumstances, 25, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Advate, octocog alfa, Hemophilia A, 02/03/2004, 31, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL), nyxthracis, Anthrax, 18/11/2020, Orphan, Additional monitoring, Exceptional circumstances, 3, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Padcev, Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms, 13/04/2022, Additional monitoring, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Scemblix, asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 25/08/2022, Orphan, Additional monitoring, 1, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 45, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Abevmy, bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms, 21/04/2021, Additional monitoring, Biosimilar, 5, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Aerius, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 49, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Azomyr, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 51, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Ecalta, anidulafungin, Candidiasis, 20/09/2007, 24, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories), 6-mercaptopurine monohydrate, Leukemia, Lymphoid, 09/03/2012, 14, Authorised
15/12/2022 Orphan designation: pentosan polysulfate sodium for the: Treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome), 21/08/2020, Positive
15/12/2022 Orphan designation: pentosan polysulfate sodium for the: Treatment of mucopolysaccharidosis type I, 19/11/2014, Positive
15/12/2022 Extended EudraVigilance medicinal product dictionary (XEVMPD) training
15/12/2022 Orphan designation: edaravone for the: Treatment of amyotrophic lateral sclerosis, 16/12/2014, Positive
15/12/2022 Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, Carcinoma, Non-Small-Cell Lung, 21/09/2018, Additional monitoring, 14, Authorised
15/12/2022 Human medicines European public assessment report (EPAR): Imlygic, talimogene laherparepvec, Melanoma, 16/12/2015, 13, Authorised
15/12/2022 Opinion on medicine for use outside EU: Aluvia, lopinavir, ritonavir, HIV Infections, 21/09/2006, Positive opinion
15/12/2022 Herbal medicinal product: Rosmarini folium, Rosmarini folium, F: Assessment finalised
15/12/2022 Agenda: Agenda for the 118th meeting of the Management Board: 14-15 December 2022
15/12/2022 Other: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) user manual
15/12/2022 Human medicines European public assessment report (EPAR): IntronA, interferon alfa-2b, Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma, 09/03/2000, 34, Withdrawn
15/12/2022 Human medicines European public assessment report (EPAR): Nityr, nitisinone, Tyrosinemias, 26/07/2018, Generic, 3, Authorised
15/12/2022 Herbal – European Union list entry: Draft European Union list entry on Foeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab., fructus - Revision 1
15/12/2022 Herbal – European Union list entry: Draft European Union list entry on Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus - Revision 1
15/12/2022 Herbal medicinal product: Foeniculi amari fructus, Foeniculi amari fructus, F: Assessment finalised
15/12/2022 Herbal medicinal product: Foeniculi dulcis fructus, Foeniculi dulcis fructus, F: Assessment finalised
14/12/2022 Summary of opinion: Enhertu, trastuzumab deruxtecan, 15/12/2022, Positive
14/12/2022 Referral: Nomegestrol and chlormadinone , nomegestrol, chlormadinone, Article 31 referrals, European Commission final decision, 01/09/2022, 28/11/2022, 14/12/2022
14/12/2022 Human medicines European public assessment report (EPAR): Retacrit, epoetin zeta, Anemia; Blood Transfusion, Autologous; Kidney Failure, Chronic; Cancer, 18/12/2007, Biosimilar, 30, Authorised
14/12/2022 Human medicines European public assessment report (EPAR): Gazyvaro, Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, 22/07/2014, Orphan, Additional monitoring, 14, Authorised
14/12/2022 Orphan designation: Concizumab for the: Treatment of haemophilia B, 12/10/2017, Withdrawn
14/12/2022 Orphan designation: Humanised monoclonal IgG4 antibody against tissue-factor-pathway inhibitor (concizumab) for the: Treatment of haemophilia A, 10/10/2012, Withdrawn
14/12/2022 Newsletter: Big Data highlights - Issue 4
14/12/2022 Orphan designation: Alisporivir for the: Treatment of collagen VI-related myopathies, 16/03/2022, Positive
14/12/2022 Agenda: Agenda - Human Variations eAF Form training session
14/12/2022 Template or form: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance
14/12/2022 Human medicines European public assessment report (EPAR): Sunosi, solriamfetol hydrochloride, Narcolepsy; Sleep Apnea, Obstructive, 16/01/2020, Additional monitoring, 7, Authorised
14/12/2022 Agenda: Agenda - Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants
14/12/2022 Orphan designation: besilesomab for the: Treatment in haematopoietic stem cell transplantation, 17/10/2019, Positive
14/12/2022 Human medicines European public assessment report (EPAR): Adtralza, Tralokinumab, Dermatitis, Atopic, 17/06/2021, Additional monitoring, 2, Authorised
14/12/2022 Human medicines European public assessment report (EPAR): Vydura, Rimegepant, Migraine Disorders, 25/04/2022, Additional monitoring, 3, Authorised
14/12/2022 Human medicines European public assessment report (EPAR): Mylotarg, gemtuzumab ozogamicin, Leukemia, Myeloid, Acute, 19/04/2018, Orphan, Additional monitoring, 11, Authorised
14/12/2022 Human medicines European public assessment report (EPAR): Xydalba, dalbavancin hydrochloride, Soft Tissue Infections; Skin Diseases, Bacterial, 19/02/2015, 15, Authorised
14/12/2022 Human medicines European public assessment report (EPAR): Livmarli, Maralixibat chloride, Alagille Syndrome, 09/12/2022, Orphan, Additional monitoring, Exceptional circumstances, Authorised
14/12/2022 Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for the: Treatment of Alagille syndrome, 18/12/2013, Positive
14/12/2022 Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Neuroblastoma, 08/05/2017, Orphan, Additional monitoring, Exceptional circumstances, 12, Authorised
14/12/2022 Human medicines European public assessment report (EPAR): Imatinib Accord, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome, 30/06/2013, Generic, 20, Authorised
14/12/2022 HMA/EMA multi-stakeholder workshop on shortages , European Medicines Agency, Amsterdam, The Netherlands, from 01/03/2023 to 02/03/2023
14/12/2022 Human medicines European public assessment report (EPAR): Repaglinide Krka, repaglinide, Diabetes Mellitus, Type 2, 03/11/2009, Generic, 8, Authorised
14/12/2022 Human medicines European public assessment report (EPAR): Enyglid, repaglinide, Diabetes Mellitus, Type 2, 13/10/2009, Generic, 9, Authorised
14/12/2022 Referral: Veterinary medicinal products containing toltrazuril to be administered orally to chickens , toltrazuril, Article 35, European Commission final decision, 14/07/2022, 09/11/2022
14/12/2022 Human medicines European public assessment report (EPAR): Orladeyo, berotralstat dihydrochloride, Angioedemas, Hereditary, 30/04/2021, 3, Authorised
13/12/2022 Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, PM: decision on the application for modification of an agreed PIP, P/0418/2019
13/12/2022 Other: European Medicines Agency’s privacy statement for the operation of the Security Access Control System
13/12/2022 Other: Record of data processing activity relating to Security Access Control System (public)
13/12/2022 Human medicines European public assessment report (EPAR): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 21/09/2017, 16, Authorised
13/12/2022 Human medicines European public assessment report (EPAR): Rezolsta, darunavir, cobicistat, HIV Infections, 19/11/2014, 15, Authorised
13/12/2022 Clinical Trials Information System (CTIS): Walk-in clinic - January 2023 , Online, 16:00 - 17:00 Amsterdam time (CET), from 18/01/2023 to 18/01/2023
13/12/2022 Clinical Trials Information System (CTIS): Walk-in clinic - February 2023 , Online, 15:00 - 16:00 Amsterdam time (CET), from 16/02/2023 to 16/02/2023
13/12/2022 Clinical Trials Information System (CTIS): Walk-in clinic - March 2023 , Online, 16:00 - 17:00 Amsterdam time (CET), from 16/03/2023 to 16/03/2023
13/12/2022 Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, Arthritis, Rheumatoid, 16/12/2019, Patient safety, Additional monitoring, 13, Authorised
13/12/2022 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system , Online, from 10/07/2023 to 14/07/2023
13/12/2022 EudraVigilance training and support
13/12/2022 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system , Online, from 19/06/2023 to 23/06/2023
13/12/2022 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system , Online, from 22/05/2023 to 26/05/2023
13/12/2022 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system , Online, from 17/04/2023 to 21/04/2023
13/12/2022 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system , Online, from 13/03/2023 to 17/03/2023
13/12/2022 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system , Online, from 30/01/2023 to 03/02/2023
13/12/2022 Work programme: Central Nervous System Working Party (CNSWP) work plan 2022-2024
13/12/2022 Agenda: Programme - Clinical Trials Information System (CTIS) sponsor end user training programme
13/12/2022 EPAR - Public assessment report: Zokinvy : EPAR - Public assessment report
13/12/2022 Clinical Trials Information System (CTIS) sponsor end user training programme - February 2023 , Online, 09:00 - 13:00 Amsterdam time (CET), from 07/02/2023 to 10/02/2023
13/12/2022 Clinical Trials Information System (CTIS) sponsor end user training programme - May 2023 , Online, 14:00 - 18:00 Amsterdam time (CEST), from 02/05/2023 to 05/05/2023
13/12/2022 Clinical Trials Information System (CTIS) sponsor end user training programme - June 2023 , Online, 14:00 - 18:00 Amsterdam time (CEST), from 27/06/2023 to 30/06/2023
13/12/2022 Withdrawn application: Hervelous, trastuzumab, Date of withdrawal: 14/09/2022, Initial authorisation
13/12/2022 Withdrawn application: Tuznue, trastuzumab, Date of withdrawal: 14/09/2022, Initial authorisation
13/12/2022 Human medicines European public assessment report (EPAR): Prezista, darunavir, HIV Infections, 11/02/2007, 54, Authorised
13/12/2022 Second European Medicines Agency and Affordable Medicines Europe bilateral meeting , Online, 10:00 - 11:00 Amsterdam time (CET), from 16/11/2022 to 16/11/2022
13/12/2022 Other: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training: frequently asked questions
13/12/2022 Presentation: Presentation - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning - Session 1.0: Introduction
13/12/2022 Human medicines European public assessment report (EPAR): Namuscla, Mexiletine hydrochloride, Myotonic Disorders, 18/12/2018, Orphan, 4, Authorised
13/12/2022 Human medicines European public assessment report (EPAR): Cyramza, Ramucirumab, Stomach Neoplasms, 19/12/2014, 15, Authorised
13/12/2022 Human medicines European public assessment report (EPAR): Ruxience, rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus, 01/04/2020, Additional monitoring, Biosimilar, 10, Authorised
13/12/2022 Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus,Dermatophagoides farinae, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0101/2019
13/12/2022 Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0084/2019
13/12/2022 Opinion/decision on a Paediatric investigation plan (PIP): birch pollen,alder pollen, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0086/2019
13/12/2022 Opinion/decision on a Paediatric investigation plan (PIP): Testosterone, PM: decision on the application for modification of an agreed PIP, P/0508/2020
13/12/2022 Other: Mandate, objectives and rules of procedure for the CHMP Biologics Working Party (BWP)
13/12/2022 Regulatory and procedural guideline: IRIS guide for parallel distribution applicants
13/12/2022 Human medicines European public assessment report (EPAR): Eviplera, emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate, HIV Infections, 27/11/2011, 25, Authorised
13/12/2022 Human medicines European public assessment report (EPAR): Scintimun, besilesomab, Osteomyelitis; Radionuclide Imaging, 11/01/2010, 6, Authorised
13/12/2022 Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate, Pulmonary Disease, Chronic Obstructive, 23/04/2018, 4, Authorised
13/12/2022 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - February 2023 , Online, 09:00 - 13:00 Amsterdam time (CET), from 13/02/2023 to 15/02/2023
13/12/2022 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - May 2023 , Online, 14:00 - 18:00 Amsterdam time (CET), from 10/05/2023 to 12/05/2023
13/12/2022 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - July 2023 , Online, 09:00 - 13:00 Amsterdam time (CET), from 03/07/2023 to 05/07/2023
13/12/2022 Human medicines European public assessment report (EPAR): Roclanda, Latanoprost, Netarsudil mesilate, Glaucoma, Open-Angle; Ocular Hypertension, 07/01/2021, Additional monitoring, 4, Authorised
13/12/2022 Human medicines European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde), irinotecan anhydrous free-base, Pancreatic Neoplasms, 14/10/2016, Orphan, 11, Authorised
13/12/2022 Work programme: Haematology Working Party (HWP) work plan 2022-2024
13/12/2022 Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, Orphan, Accelerated assessment, Additional monitoring, 10, Authorised