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Mar 2020 (227) Apr 2020 (239) May 2020 (207) Jun 2020 (318) Jul 2020 (263) Aug 2020 (228) Sep 2020 (196) Oct 2020 (306) Nov 2020 (349) Dec 2020 (368) Jan 2021 (379) Feb 2021 (554) Mar 2021 (237)
Date Content
05/03/2021 Report: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive - 2020 (new)
05/03/2021 Referrals document: Eli Lilly and Company Limited antibody combination (bamlanivimab / etesevimab - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring (new)
05/03/2021 COVID-19: latest updates (updated)
05/03/2021 COVID-19 treatments: Article 5(3) reviews (updated)
05/03/2021 News and press releases: EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)
05/03/2021 Human medicines European public assessment report (EPAR): Onbevzi, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 11/01/2021, Additional monitoring, Biosimilar, Authorised
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Palovarotene, PM: decision on the application for modification of an agreed PIP, P/0144/2020 (updated)
05/03/2021 Veterinary medicines European public assessment report (EPAR): Purevax FeLV, feline leukaemia virus recombinant canarypox virus (vCP97), 13/04/2000, 12, Authorised (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat, PM: decision on the application for modification of an agreed PIP, P/0160/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide, PM: decision on the application for modification of an agreed PIP, P/0137/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Etrolizumab, PM: decision on the application for modification of an agreed PIP, P/0168/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): hydrocortisone,benzocaine, W: decision granting a waiver in all age groups for all conditions or indications, P/0181/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): rosuvastatin calcium,fenofibrate, W: decision granting a waiver in all age groups for all conditions or indications, P/0170/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): 18-(p-[131I]-iodophenyl)octadecyl phosphocholine, W: decision granting a waiver in all age groups for all conditions or indications, P/0169/2020
05/03/2021 Human medicines European public assessment report (EPAR): Vizarsin, sildenafil, Erectile Dysfunction, 21/09/2009, Generic, 16, Authorised (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Stivarga, regorafenib, PM: decision on the application for modification of an agreed PIP, P/0141/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Pneumococcal Polyssacharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0159/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Constella, linaclotide, PM: decision on the application for modification of an agreed PIP, P/0135/2020 (updated)
05/03/2021 Workshop on the General Data Protection Regulation (GDPR) and secondary use of data for medicines and public health purposes , Virtual meeting, from 29/09/2020 to 29/09/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Difelikefalin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0172/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): imatinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0171/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Cyclophosphamide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0191/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Tiragolumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0186/2020
05/03/2021 Clinical Trials Information System (CTIS): training programme (updated)
05/03/2021 Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma, 20/09/2017, Additional monitoring, 13, Authorised (updated)
05/03/2021 Availability of medicines (updated)
05/03/2021 Applying for marketing authorisation: orphan medicines (updated)
05/03/2021 Other: Pilot project ‘Market Launch Intentions of Centrally Authorised Products’ - practical questions and answers (new)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Ravagalimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0241/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Atropine (sulfate), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0237/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human RPGR gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0229/2020
05/03/2021 News and press releases: EMA website briefly unavailable on 8 March 2021
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Gepotidacin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0212/2020
05/03/2021 Real world research on medicines: contribution of the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) , Virtual event, from 08/03/2021 to 08/03/2021 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Gepotidacin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0213/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): fidanacogene elaparvovec, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0222/2020
05/03/2021 Human medicines European public assessment report (EPAR): Iressa, gefitinib, Carcinoma, Non-Small-Cell Lung, 24/06/2009, 14, Authorised (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo], PM: decision on the application for modification of an agreed PIP, P/0138/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Victrelis, Boceprevir, W: decision granting a waiver in all age groups for all conditions or indications, P/0156/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib, PM: decision on the application for modification of an agreed PIP, P/0165/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Sodium alginate oligosaccharide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0235/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab, PM: decision on the application for modification of an agreed PIP, P/0143/2020 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0353/2018 (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Bis-choline tetrathiomolybdate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0234/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): 4-[4-({4-[({2-[(3S)-2,6-dioxopiperidin-3-yl]-1-oxo-2,3-dihydro-1H-isoindol-4-yl}oxy)methyl]phenyl}methyl)piperazin-1-yl]-3-fluorobenzonitrile, W: decision granting a waiver in all age groups for all conditions or indications, P/0153/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Pneumococcal polysaccharides individually biotinylated and complexed with a carrier protein (recombinant fusion construct of rhizavidin and Streptococcus pneumoniae derived proteins), 24-valent, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0146/2020
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0211/2020
05/03/2021 Human medicines European public assessment report (EPAR): Trizivir, abacavir (as sulfate), lamivudine, zidovudine, HIV Infections, 27/12/2000, 36, Authorised (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): temozolomide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0147/2020
05/03/2021 Veterinary medicines European public assessment report (EPAR): Gumbohatch, live attenuated infectious bursal disease virus (IBDV), strain 1052, 12/11/2019, 2, Authorised (updated)
05/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5- fluorobenzonitrile, W: decision granting a waiver in all age groups for all conditions or indications, P/0154/2020
05/03/2021 Human medicines European public assessment report (EPAR): Pemetrexed Accord, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 18/01/2016, Generic, 6, Authorised (updated)
05/03/2021 Human medicines European public assessment report (EPAR): Integrilin, eptifibatide, Angina, Unstable, Myocardial Infarction, 01/07/1999, 25, Authorised (updated)
05/03/2021 Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Prostatic Neoplasms, 21/06/2013, 26/04/2013, 16, Authorised (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): isoflurane, PM: decision on the application for modification of an agreed PIP, P/0190/2020 (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Idasanutlin, PM: decision on the application for modification of an agreed PIP, P/0196/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Arfolitixorin, W: decision granting a waiver in all age groups for all conditions or indications, P/0182/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Livoletide, W: decision granting a waiver in all age groups for all conditions or indications, P/0176/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Spesolimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0195/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Setmelanotide, PM: decision on the application for modification of an agreed PIP, P/0179/2020 (updated)
04/03/2021 Other: Article 57 product data (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, PM: decision on the application for modification of an agreed PIP, P/0197/2020 (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate), PM: decision on the application for modification of an agreed PIP, P/0173/2020 (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Alicaforsen, PM: decision on the application for modification of an agreed PIP, P/0180/2020 (updated)
04/03/2021 Human medicines European public assessment report (EPAR): Azomyr, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 45, Authorised (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Avalglucosidase alfa, PM: decision on the application for modification of an agreed PIP, P/0174/2020 (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen, PM: decision on the application for modification of an agreed PIP, P/0185/2020 (updated)
04/03/2021 Human medicines European public assessment report (EPAR): Vipdomet, alogliptin benzoate, metformin hydrochloride, Diabetes Mellitus, Type 2, 18/09/2013, 7, Authorised (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0210/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Varuby, rolapitant, W: decision granting a waiver in all age groups for all conditions or indications, P/0194/2020 (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), PM: decision on the application for modification of an agreed PIP, P/0188/2020 (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride, W: decision granting a waiver in all age groups for all conditions or indications, P/0216/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor,ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0193/2020 (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0219/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Giotrif, afatinib, PM: decision on the application for modification of an agreed PIP, P/0184/2020 (updated)
04/03/2021 CHMP opinions on consultation procedures (updated)
04/03/2021 Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021 , Virtual meeting, from 25/01/2021 to 29/01/2021 (updated)
04/03/2021 Other: Origio - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: Steen solution - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: Irvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: Gems Medium Suite - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: IVF Media G5 - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: COOK IVF cell culture media - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Other: FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation (updated)
04/03/2021 Minutes: Minutes of the CHMP meeting 25-29 January 2021 (new)
04/03/2021 Report: List of products granted eligibility to PRIME (updated)
04/03/2021 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 22-25 February 2021 (new)
04/03/2021 Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone, Neoplasm Metastasis, 13/07/2011, 21, Authorised (updated)
04/03/2021 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, 3, Authorised (updated)
04/03/2021 Human medicines European public assessment report (EPAR): COVID-19 Vaccine Moderna, CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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, 06/01/2021, Additional monitoring, Conditional approval, Authorised (updated)
04/03/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Moderna: March 2021 (new)
04/03/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: March 2021 (new)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Polymyxin B, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0157/2020
04/03/2021 Human medicines European public assessment report (EPAR): Nimenrix, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 20/04/2012, 32, Authorised (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Bintrafusp alfa, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0150/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): N-(3-{6-Amino-5-[2-(N-methylprop-2-enamido)ethoxy]pyrimidin-4-yl}-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0158/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Pracinostat, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0126/2020
04/03/2021 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2021 (new)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): elbasvir, PM: decision on the application for modification of an agreed PIP, P/0313/2015 (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Lebrikizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0151/2020
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): grazoprevir, PM: decision on the application for modification of an agreed PIP, P/0312/2015 (updated)
04/03/2021 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (new)
04/03/2021 Human medicines European public assessment report (EPAR): Glubrava, metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/12/2007, 17, Authorised (updated)
04/03/2021 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Bupivacaine (new)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Ibrexafungerp, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0164/2020
04/03/2021 Human medicines European public assessment report (EPAR): Competact, pioglitazone, metformin hydrochloride, Diabetes Mellitus, Type 2, 28/07/2006, 18, Authorised (updated)
04/03/2021 COVID-19 vaccines: under evaluation (updated)
04/03/2021 COVID-19 vaccines (updated)
04/03/2021 News and press releases: EMA starts rolling review of the Sputnik V COVID-19 vaccine
04/03/2021 Human medicines European public assessment report (EPAR): Actos, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 13/10/2000, 27, Authorised (updated)
04/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): glycerol,urea, W: decision granting a waiver in all age groups for all conditions or indications, P/0128/2020
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Dihomo-y-linolenic acid, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0129/2020
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): 2-[[2-ethyl-6-[4-[2-(3-hydroxyazetidin-1-yl)-2-oxoethyl]piperazin-1-yl]-8-methylimidazo[1,2-a]pyridin-3-yl](methyl)amino]-4-(4-fluorophenyl)-1,3-thiazole-5-carbonitrile, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0148/2020
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): (S)-(2-(5-chloro-4-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(4-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone hydrochloride (daridorexant), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0131/2020
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): leriglitazone, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0152/2020
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): lenadogene nolparvovec, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0166/2020
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, lanadelumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0140/2020
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Propan-2-yl 2-[5-( acryloylamino )-4-{ [2-( dimethylamino )ethyl] ( methyl)amino }-2-methoxyanilino ]-4- ( 1 methyl-1 H-indol-3-yl)pyrimidine-5-carboxylate, W: decision granting a waiver in all age groups for all conditions or indications, P/0161/2020
03/03/2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 2 , Virtual event, from 04/03/2021 to 04/03/2021 (updated)
03/03/2021 Other: Speaker bios - SME and Academia Clinical Trials Information System (CTIS) two-part training webinar (updated)
03/03/2021 Human medicines European public assessment report (EPAR): Ninlaro, ixazomib citrate, Multiple Myeloma, 21/11/2016, Orphan, Additional monitoring, Conditional approval, 9, Authorised (updated)
03/03/2021 Joint HMA/EMA workshop on artificial intelligence in medicines regulation , Virtual event, from 19/04/2021 to 20/04/2021
03/03/2021 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 (updated)
03/03/2021 Report: Annual report on the use of the special contribution for orphan medicinal products - 2020 (new)
03/03/2021 Human medicines European public assessment report (EPAR): Maviret, glecaprevir, pibrentasvir, Hepatitis C, Chronic, 26/07/2017, Accelerated assessment, Additional monitoring, 11, Authorised (updated)
03/03/2021 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
03/03/2021 Agenda: Agenda - HMPC agenda of the 1-3 March 2021 meeting (new)
03/03/2021 Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for the: Treatment of post-polycythaemia vera myelofibrosis, 26/11/2010, Positive (updated)
03/03/2021 Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for the: Treatment of post-essential thrombocythaemia myelofibrosis, 26/11/2010, Positive (updated)
03/03/2021 Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for the: Treatment of primary myelofibrosis, 01/10/2010, Positive (updated)
03/03/2021 Human medicines European public assessment report (EPAR): Inrebic, fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders, Primary Myelofibrosis, 08/02/2021, Orphan, Additional monitoring, Authorised
03/03/2021 Human medicines European public assessment report (EPAR): Nexium Control, esomeprazole, Gastroesophageal Reflux, 26/08/2013, 15, Authorised (updated)
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): lazertinib (mesilate), W: decision granting a waiver in all age groups for all conditions or indications, P/0127/2020
03/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): alpha1-proteinase inhibitor (human), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0134/2020
03/03/2021 United States (updated)
02/03/2021 Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 11 March 2021 , Virtual meeting, from 11/03/2020 to 11/03/2020
02/03/2021 Other: LifeGlobal Media - Procedural steps and scientific information after initial consultation (new)
02/03/2021 Other: Nullification ICSRs received by EudraVigilance (updated)
02/03/2021 Report: Medicinal products for human use: monthly figures - January 2021 (new)
02/03/2021 Orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide) for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours, 14/12/2015, Positive (updated)
02/03/2021 Orphan designation: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea (netazepide) for the: Treatment of gastric carcinoid, 14/06/2007, Positive (updated)
02/03/2021 Human medicines European public assessment report (EPAR): Tandemact, pioglitazone, glimepiride, Diabetes Mellitus, Type 2, 08/01/2007, 18, Authorised (updated)
02/03/2021 Human medicines European public assessment report (EPAR): Glustin, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/10/2000, 26, Authorised (updated)
02/03/2021 Management Board meeting: 16-17 December 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 16/12/2020 to 17/12/2020 (updated)
02/03/2021 Minutes: Minutes of the 110th meeting of the Management Board: 16-17 December 2020 (new)
02/03/2021 Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Amyloidosis, 16/11/2011, Orphan, Additional monitoring, Exceptional circumstances, 18, Authorised (updated)
02/03/2021 News and press releases: EMA review of regdanvimab for COVID-19 to support national decisions on early use
02/03/2021 Human medicines European public assessment report (EPAR): Neupro, rotigotine, Restless Legs Syndrome, Parkinson Disease, 15/02/2006, 30, Authorised (updated)
02/03/2021 Human medicines European public assessment report (EPAR): Avamys, fluticasone furoate, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, 11/01/2008, 21, Authorised (updated)
02/03/2021 Orphan designation: N-(4-(1-cyanocyclopentyl)phenyl)-2-(4-pyridinylmethyl)amino-3-pyridinecarboxamide methanesulfonate for the: Treatment of gastric cancer, 27/02/2017, Positive (updated)
02/03/2021 Orphan designation: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene for the: Treatment of congenital alpha-1 antitrypsin deficiency, 31/07/2018, Positive (updated)
02/03/2021 Veterinary Big Data stakeholder forum , Virtual event, from 01/06/2021 to 02/06/2021
02/03/2021 Agenda: Programme - Veterinary Big Data Stakeholder Forum (new)
02/03/2021 COVID-19 vaccines: authorised (updated)
02/03/2021 News and press releases: EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
02/03/2021 Recruitment: Careers at EMA user-guide (updated)
02/03/2021 Veterinary medicines European public assessment report (EPAR): Equisolon, Prednisolone, 12/03/2014, 7, Authorised (updated)
02/03/2021 Other: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA) (updated)
02/03/2021 Human medicines European public assessment report (EPAR): DaTSCAN, ioflupane (123l), Tomography, Emission-Computed, Single-Photon, Lewy Body Disease, Parkinson Disease, Alzheimer Disease, 27/07/2000, 22, Authorised (updated)
02/03/2021 Herbal medicinal product: Ginseng radix, Ginseng radix, F: Assessment finalised (updated)
02/03/2021 Herbal medicinal product: Juglandis folium, Juglandis folium, F: Assessment finalised (updated)
02/03/2021 Herbal medicinal product: Levistici radix, Levistici radix, F: Assessment finalised (updated)
02/03/2021 Herbal medicinal product: Grindeliae herba , Grindeliae herba, F: Assessment finalised (updated)
02/03/2021 Herbal medicinal product: Eucalypti aetheroleum, Eucalypti aetheroleum, F: Assessment finalised (updated)
02/03/2021 Herbal medicinal product: Eucalypti folium, Eucalypti folium, F: Assessment finalised (updated)
02/03/2021 Herbal medicinal product: Hippocastani cortex, Hippocastani cortex, F: Assessment finalised (updated)
02/03/2021 Herbal medicinal product: Fraxini folium, Fraxini folium, F: Assessment finalised (updated)
02/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Eucalypti aetheroleum (new)
02/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Eucalypti folium (new)
02/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Fraxini folium (new)
02/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Ginseng radix (new)
02/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Grindeliae herba (new)
02/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Hippocastani cortex (new)
02/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Juglandis folium (new)
02/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Levistici radix (new)
02/03/2021 Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome, 24/04/2008, 26, Authorised (updated)
02/03/2021 Minutes: Minutes of the CHMP meeting 7-10 December 2020 (new)
02/03/2021 Minutes: Minutes of the CVMP meeting of 19-20 January 2021 (new)
02/03/2021 Dapivirine Vaginal Ring 25 mg H-W-2168 (updated)
02/03/2021 Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group , valsartan, candesartan, irbesartan, losartan and olmesartan , Article 31 referrals, European Commission final decision, 12/11/2020, 19/02/2021, 02/03/2021 (updated)
02/03/2021 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections, Skin Diseases, Infectious, Pneumonia, 22/08/2012, 24, Authorised (updated)
02/03/2021 EPAR - Assessment report - Variation: Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines in human medicinal products on the Opinion adopted pursuant to Article 31 of Directive 2001/83/EC (new)
01/03/2021 Plasma master file certificates (updated)
01/03/2021 Antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products (updated)
01/03/2021 Overview of comments: Overview of comments received on the 'Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - First version' (new)
01/03/2021 Scientific guideline: Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - First version (new)
01/03/2021 Human medicines European public assessment report (EPAR): Leganto, rotigotine, Restless Legs Syndrome, Parkinson Disease, 16/06/2011, 19, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, 09/06/2000, 36, Authorised (updated)
01/03/2021 Minutes: Minutes - PDCO minutes of the 8-11 December 2020 meeting (new)
01/03/2021 Maximum Residue Limits - Report: Lidocaine (bovine): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use (new)
01/03/2021 Veterinary medicines European public assessment report (EPAR): Coliprotec F4/F18, Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac), 09/01/2017, 3, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Bortezomib Sun, bortezomib, Multiple Myeloma, 22/07/2016, Generic, 10, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial, 22/03/2017, Generic, 10, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Nucala, Mepolizumab, Asthma, 01/12/2015, 14, Authorised (updated)
01/03/2021 Overview of comments: Overview of comments received on 'Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version' (new)
01/03/2021 Human medicines European public assessment report (EPAR): Velcade, bortezomib, Multiple Myeloma, 26/04/2004, 44, Authorised (updated)
01/03/2021 Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version (new)
01/03/2021 Use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health (updated)
01/03/2021 Agenda: Programme -European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021 (updated)
01/03/2021 European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021 , Virtual meeting, from 25/03/2021 to 25/03/2021 (updated)
01/03/2021 Supply shortage: Nucala (mepolizumab) pre-filled pen supply shortage (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Flixabi, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis, 26/05/2016, Additional monitoring, Biosimilar, 16, Authorised (updated)
01/03/2021 Supply shortage: Respreeza (human alpha1-proteinase inhibitor) supply shortage (updated)
01/03/2021 Maximum residue limits (MRL) (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Qutenza, capsaicin, Neuralgia, 15/05/2009, 15, Authorised (updated)
01/03/2021 Veterinary medicines European public assessment report (EPAR): Draxxin, tulathromycin, 11/11/2003, 24, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Karvezide, irbesartan, hydrochlorothiazide, Hypertension, 16/10/1998, 40, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Topotecan Hospira, topotecan, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 09/06/2010, 16, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 11, Authorised (updated)
01/03/2021 Committee for Orphan Medicinal Products (COMP): 16-18 February 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 16/02/2021 to 18/02/2021 (updated)
01/03/2021 Committee meeting report: COMP meeting report on the review of applications for orphan designation: February 2021 (new)
01/03/2021 Human medicines European public assessment report (EPAR): Heplisav B, hepatitis B surface antigen, Hepatitis B, 18/02/2021, Additional monitoring, Authorised
01/03/2021 Human medicines European public assessment report (EPAR): Stelara, Ustekinumab, Psoriasis, Arthritis, Psoriatic, Crohn Disease, 15/01/2009, 34, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Orfadin, nitisinone, Tyrosinemias, 20/02/2005, 20, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic, 19/09/2019, Orphan, 5, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Repatha, Evolocumab, Dyslipidemias, Hypercholesterolemia, 17/07/2015, 16, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Pioglitazone Teva, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 26/03/2012, Generic, 11, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Braftovi, Encorafenib, Melanoma, Colorectal Neoplasms, 19/09/2018, Additional monitoring, 5, Authorised (updated)
01/03/2021 Maximum Residue Limits - Report: Bupivacaine (bovine species): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use (new)
01/03/2021 Human medicines European public assessment report (EPAR): Gencebok, Caffeine citrate, Apnea, 19/08/2020, 2, Authorised (updated)
01/03/2021 Veterinary medicines European public assessment report (EPAR): Exzolt, fluralaner, 18/08/2017, 2, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 17, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Eylea, aflibercept, Wet Macular Degeneration, Macular Edema, Diabetes Complications, 21/11/2012, 20, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Drug-Related Side Effects and Adverse Reactions, 26/04/2019, Additional monitoring, Conditional approval, 8, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 40, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Glivec, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, 07/11/2001, Additional monitoring, 40, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 41, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Byetta, exenatide, Diabetes Mellitus, Type 2, 20/11/2006, 24, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, 16, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 21, Authorised (updated)
01/03/2021 Other: European Medicines Agency practical guidance on the application form for centralised type IA and IB variations (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 42, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Tadalafil Lilly, tadalafil, Erectile Dysfunction, 22/03/2017, 3, Authorised (updated)
01/03/2021 Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 29, Authorised (updated)