What's new

RSS
Date Content
31/03/2020 News and press releases: Advancing regulatory science in the EU – new strategy adopted
31/03/2020 Regulatory and procedural guideline: EMA Regulatory Science to 2025 - Strategic reflection
31/03/2020 Regulatory science strategy
31/03/2020 News and press releases: Update on treatments and vaccines against COVID-19 under development
31/03/2020 Orphan designation: Autologous adult bone marrow-derived non-expanded CD133+ haematopoietic stem cells for the: Treatment of Asherman's syndrome, 20/04/2017, Positive
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate), PM: decision on the application for modification of an agreed PIP, P/0384/2019
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Rubidium (82Rb) chloride, PM: decision on the application for modification of an agreed PIP, P/0391/2019
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Otezla, apremilast, PM: decision on the application for modification of an agreed PIP, P/0389/2019
31/03/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 10-13 February 2020 PRAC meeting
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0382/2019
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Otezla, apremilast, PM: decision on the application for modification of an agreed PIP, P/0388/2019
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): 3-[5-[(1R,2S)-2-(2,2-difluoropropanoylamino)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)propoxy]indazol-1- yl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0402/2019
31/03/2020 Human medicines European public assessment report (EPAR): Prasugrel Mylan, prasugrel besilate, Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable, 15/05/2018, Generic, 5, Authorised
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide, PM: decision on the application for modification of an agreed PIP, P/0410/2019
31/03/2020 Human medicines European public assessment report (EPAR): Grasustek, pegfilgrastim, Neutropenia, 20/06/2019, Additional monitoring, Biosimilar, 1, Authorised
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0401/2019
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19), W: decision granting a waiver in all age groups for all conditions or indications, P/0433/2019
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, PM: decision on the application for modification of an agreed PIP, P/0408/2019
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Saxenda, liraglutide, PM: decision on the application for modification of an agreed PIP, P/0383/2019
31/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, Dalbavancin, PM: decision on the application for modification of an agreed PIP, P/0377/2019
31/03/2020 Human medicines European public assessment report (EPAR): Epclusa, Sofosbuvir, velpatasvir, Hepatitis C, Chronic, 06/07/2016, Accelerated assessment, Additional monitoring, 12, Authorised
30/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm, clopidogrel (as hydrogen sulfate), Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke, 18/02/2015, Generic, 9, Authorised
30/03/2020 Committee for Medicinal Products for Human Use (CHMP): 09-12 December 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 09/12/2019 to 12/12/2019
30/03/2020 Veterinary medicines European public assessment report (EPAR): Zulvac 1 Bovis, inactivated bluetongue virus, serotype 1, 05/08/2011, Accelerated assessment, 7, Withdrawn
30/03/2020 Minutes: CHMP ORGAM minutes for the meeting on 2 December 2019
30/03/2020 Agenda: CHMP ORGAM agenda for the meeting on 2 December 2019
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate (STS), PM: decision on the application for modification of an agreed PIP, P/0368/2019
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Pevonedistat, PM: decision on the application for modification of an agreed PIP, P/0386/2019
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): eflornithine (hydrochloride monohydrate),sulindac, RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0419/2019
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain B (Victoria lineage),Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0372/2019
30/03/2020 News and press releases: EMA to issue electronic certificates for medicines
30/03/2020 Certification of medicinal products
30/03/2020 Other: Information package for certificates of medicinal products issued by the European Medicines Agency
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate,glycopyrronium bromide (CHF 5993), PM: decision on the application for modification of an agreed PIP, P/0365/2019
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Xalkori, crizotinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0399/2019
30/03/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: March 2020
30/03/2020 Minutes: Minutes of the HMPC 23-25 September 2019 meeting
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, PM: decision on the application for modification of an agreed PIP, P/0374/2019
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Prevymis, Letermovir, PM: decision on the application for modification of an agreed PIP, P/0362/2019
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Latuda, Lurasidone hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0359/2019
30/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Daklinza, Daclatasvir, W: decision granting a waiver in all age groups for all conditions or indications, P/0367/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, Avatrombopag (maleate), PM: decision on the application for modification of an agreed PIP, P/0373/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Plegridy, peginterferon beta-1a, PM: decision on the application for modification of an agreed PIP, P/0371/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Volibris, ambrisentan, PM: decision on the application for modification of an agreed PIP, P/0370/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Lubiprostone, PM: decision on the application for modification of an agreed PIP, P/0363/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Selpercatinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0369/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Remimazolam (as besylate), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0364/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ganaxolone, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0361/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ilaris, Canakinumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0366/2019
27/03/2020 News and press releases: EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic
27/03/2020 EudraVigilance: how to register
27/03/2020 Other: Vendor registration in the EudraVigilance external compliance testing environment (XCOMP) - Registration procedure
27/03/2020 News and press releases: No change to product information for breast cancer medicine Tyverb following re-assessment of data
27/03/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)
27/03/2020 Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 2-4 March 2020
27/03/2020 Minutes: Minutes of the COMP meeting 3-5 December 2019
27/03/2020 News and press releases: Restrictions in use of cyproterone due to meningioma risk
27/03/2020 News and press releases: Recommendations to restrict use of fosfomycin antibiotics
27/03/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 9-12 March 2020
27/03/2020 News and press releases: No change is needed in use of direct oral anticoagulants following EMA-funded study
27/03/2020 Report: Medicinal products for human use: monthly figures - February 2020
27/03/2020 News and press releases: Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Onasemnogenum abeparvovecum, PM: decision on the application for modification of an agreed PIP, P/0315/2019
27/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, PM: decision on the application for modification of an agreed PIP, P/0337/2019
27/03/2020 Veterinary medicines European public assessment report (EPAR): Aftovaxpur DOE, Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063., 15/07/2013, 16/05/2013, 8, Authorised
27/03/2020 Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, 31/08/2018, Additional monitoring, 1, Authorised
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Odevixibat, PM: decision on the application for modification of an agreed PIP, P/0316/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin) of strain A (H1N1),influenza virus surface antigens (haemagglutinin) of strain A (H3N2),influenza virus surface antigens (haemagglutinin) of strain B  (Victoria lineage),influenza virus surface antigens (haemagglutinin) of strain B (Yamagata lineage), W: decision granting a waiver in all age groups for all conditions or indications, P/0340/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Larotrectinib, PM: decision on the application for modification of an agreed PIP, P/0318/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Dovato, lamivudine,dolutegravir, PM: decision on the application for modification of an agreed PIP, P/0319/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): 2-hydroxypropyl-ß-cyclodextrin (HP-ß-CD), PM: decision on the application for modification of an agreed PIP, P/0348/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm. f. (fresh fruit),Paullinia cupana Kunth,Theobroma cacao L., PM: decision on the application for modification of an agreed PIP, P/0321/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib, PM: decision on the application for modification of an agreed PIP, P/0322/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel, PM: decision on the application for modification of an agreed PIP, P/0323/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Finerenone, PM: decision on the application for modification of an agreed PIP, P/0324/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide, PM: decision on the application for modification of an agreed PIP, P/0326/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Etrolizumab, PM: decision on the application for modification of an agreed PIP, P/0327/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Cotellic, Cobimetinib, PM: decision on the application for modification of an agreed PIP, P/0306/2019
26/03/2020 Orphan designation: 2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide (namodenoson) for the: Treatment of hepatocellular carcinoma, 09/10/2015, Positive
26/03/2020 Human medicines European public assessment report (EPAR): Lysodren, Mitotane, Adrenal Cortex Neoplasms, 28/04/2004, 15, Authorised
26/03/2020 Orphan designation: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor for the: Treatment of haemophilia A, 22/02/2018, Withdrawn
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus,dermatophagoides farinae allergen extract, PM: decision on the application for modification of an agreed PIP, P/0328/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Afstyla, lonoctocog alfa, PM: decision on the application for modification of an agreed PIP, P/0329/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Cinqaero, Reslizumab, PM: decision on the application for modification of an agreed PIP, P/0284/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Feraccru, ferric maltol, PM: decision on the application for modification of an agreed PIP, P/0330/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Evarrest, human fibrinogen,human thrombin, PM: decision on the application for modification of an agreed PIP, P/0339/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib, PM: decision on the application for modification of an agreed PIP, P/0331/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin, PM: decision on the application for modification of an agreed PIP, P/0345/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Votrient, pazopanib, PM: decision on the application for modification of an agreed PIP, P/0333/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Betmiga, Mirabegron, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0350/2017
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril,valsartan, PM: decision on the application for modification of an agreed PIP, P/0344/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Bexsero, recombinant Neisseria meningitidis group B NHBA fusion protein,recombinant Neisseria meningitidis group B NadA protein,recombinant Neisseria meningitidis group B fHbp fusion protein,Outer Membrane Vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4, PM: decision on the application for modification of an agreed PIP, P/0334/2019
26/03/2020 International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren, PM: decision on the application for modification of an agreed PIP, P/0335/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / N. meningitidis,serogroup C polysaccharide conjugated to tetanus toxoid / N. meningitidis serogroup Y polysaccharide,conjugated to tetanus toxoid / N. meningitidis serogroup W polysaccharide conjugated to tetanus,toxoid (MenACYW), PM: decision on the application for modification of an agreed PIP, P/0169/2019
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Januvia, sitagliptin, PM: decision on the application for modification of an agreed PIP, P/0358/2019
26/03/2020 Human medicines European public assessment report (EPAR): Sifrol, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 13/10/1997, 33, Authorised
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): 2-(3-(1-carboxy-5-[(6-[18F]fluoropyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid, W: decision granting a waiver in all age groups for all conditions or indications, P/0357/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor (CAR) for B-cell maturation antigen (BCMA) (JNJ-68284528), W: decision granting a waiver in all age groups for all conditions or indications, P/0353/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ecopipam (hydrochloride), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0351/2019
25/03/2020 Periodic safety update single assessment: Fosfomycin (IV formulation): List of nationally authorised medicinal products - PSUSA/00010336/201907
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Botulinum toxin type A, W: decision granting a waiver in all age groups for all conditions or indications, P/0307/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): 7-(2-Methoxy-3,5-dimethylpyridin-4-yl)-1-[(3S)-tetrahydrofuran-3-yl]-1,5-dihydro-4H-pyrazolo[4,3-c]quinolin-4-one maleate, W: decision granting a waiver in all age groups for all conditions or indications, P/0354/2019
25/03/2020 Scientific guideline: Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
25/03/2020 Biostatistics
25/03/2020 Agenda: Agenda - PDCO agenda of the 24-27 March 2020 meeting
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): aprocitentan, W: decision granting a waiver in all age groups for all conditions or indications, P/0356/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Infigratinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0301/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Fexapotide (friflutate), W: decision granting a waiver in all age groups for all conditions or indications, P/0346/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): zofenopril,nebivolol, W: decision granting a waiver in all age groups for all conditions or indications, P/0308/2019
25/03/2020 Clinical trials in human medicines
25/03/2020 Human medicines European public assessment report (EPAR): Lojuxta, Lomitapide, Hypercholesterolemia, 31/07/2013, Additional monitoring, Exceptional circumstances, 12, Authorised
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Atropine (sulphate) / Obidoxime (chloride), W: decision granting a waiver in all age groups for all conditions or indications, P/0309/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): human fibrinogen, W: decision granting a waiver in all age groups for all conditions or indications, P/0352/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,Ramipril, W: decision granting a waiver in all age groups for all conditions or indications, P/0343/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,Ramipril, W: decision granting a waiver in all age groups for all conditions or indications, P/0343/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): levonorgestrel, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0302/2019
25/03/2020 Report: 10-year annual report on MUMS/limited market scheme for veterinary medicines
25/03/2020 News and press releases: Ten years of MUMS: 22 new veterinary medicines authorised for minor uses and minor species
25/03/2020 EudraVigilance
25/03/2020 Other: EudraVigilance Operational Plan - Milestones 2020 to 2022
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): belantamab mafodotin, W: decision granting a waiver in all age groups for all conditions or indications, P/0347/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): dostarlimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0303/2019
25/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): PEGylated-fibroblast growth factor 21 (BMS-986036), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0336/2019
25/03/2020 Human medicines European public assessment report (EPAR): Mirapexin, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome, Parkinson Disease, 23/02/1998, 36, Authorised
25/03/2020 Human medicines European public assessment report (EPAR): Ameluz, 5-aminolevulinic acid hydrochloride, Keratosis, Actinic, Carcinoma, Basal Cell, 13/12/2011, 15, Authorised
25/03/2020 Public Statement: Public statement on Kromeya: Withdrawal of the marketing authorisation in the European Union
25/03/2020 Periodic safety update single assessment: Fosfomycin (oral formulation): List of nationally authorised medicinal products - PSUSA/00010326/201907
25/03/2020 Human medicines European public assessment report (EPAR): Kromeya, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, 02/04/2019, Additional monitoring, Biosimilar, 4, Withdrawn
25/03/2020 Human medicines European public assessment report (EPAR): Zalasta, olanzapine, Schizophrenia, Bipolar Disorder, 27/09/2007, Generic, 17, Authorised
25/03/2020 Human medicines European public assessment report (EPAR): Fasturtec, rasburicase, Hyperuricemia, 23/02/2001, 25, Authorised
24/03/2020 Human medicines European public assessment report (EPAR): Cuprymina, copper (64Cu) chloride, Radionuclide Imaging, 23/08/2012, 7, Authorised
24/03/2020 News and press releases: Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
24/03/2020 Human medicines European public assessment report (EPAR): Rotarix, human rotavirus, live attenuated, Immunization, Rotavirus Infections, 21/02/2006, 35, Authorised
24/03/2020 News and press releases: COVID-19: Beware of falsified medicines from unregistered websites
24/03/2020 Buying medicines online
24/03/2020 Human medicines European public assessment report (EPAR): Levetiracetam Actavis, levetiracetam, Epilepsy, 03/10/2011, Generic, 15, Authorised
24/03/2020 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, 25, Authorised
24/03/2020 Human medicines European public assessment report (EPAR): Insulin lispro Sanofi, insulin lispro, Diabetes Mellitus, 18/07/2017, Additional monitoring, Biosimilar, 5, Authorised
24/03/2020 Human medicines European public assessment report (EPAR): DuoResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 9, Authorised
23/03/2020 Human medicines European public assessment report (EPAR): Zypadhera, olanzapine pamoate, Schizophrenia, 19/11/2008, 19, Authorised
23/03/2020 Direct healthcare professional communication (DHPC): Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk, Active substance: uliprista acetate 5mg, DHPC type: Interim measures, Last updated: 23/03/2020
23/03/2020 Human medicines European public assessment report (EPAR): Gardasil, human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization, 20/09/2006, 42, Authorised
23/03/2020 Direct healthcare professional communication: Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk
23/03/2020 Paediatric Committee (PDCO): 12-15 November 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 12/11/2019 to 15/11/2019
23/03/2020 Minutes: Minutes - PDCO minutes of the 12-15 November 2019 meeting
23/03/2020 Agenda: Agenda - CHMP agenda of the 23-26 March 2020 meeting
23/03/2020 Human medicines European public assessment report (EPAR): Atriance, nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, 22/08/2007, Additional monitoring, Exceptional circumstances, 23, Authorised
23/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0304/2019
23/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Baloxavir marboxil, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0300/2019
23/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Tirzepatide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0311/2019
23/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): liposomal ciclosporin A (L-CsA), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0312/2019
23/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib (tosylate monohydrate), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0313/2019
23/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Eptinezumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0314/2019
23/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant Hepatitis B vaccine, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0342/2019
20/03/2020 Human medicines European public assessment report (EPAR): Ambrisentan Mylan, ambrisentan, Hypertension, Pulmonary, 20/06/2019, Generic, 1, Authorised
20/03/2020 Agenda: Agenda - COMP agenda of the 17-19 March 2020 meeting
20/03/2020 Report: Summary of transfers of appropriations in budget 2019 - Issues for consideration - Management Board meeting of 19 March 2020
20/03/2020 Regulatory and procedural guideline: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2020
20/03/2020 Other: Outcome of written procedures finalised during the period from 23 November 2019 to 20 February 2020
20/03/2020 Report: 2019 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission - Reporting period: 1 January to 31 December 2019
20/03/2020 News and press releases: Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
20/03/2020 Agenda: Agenda - Third European Medicines Agency-Medicines for Europe bilateral meeting
20/03/2020 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020
20/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): pegvorhyaluronidase alpha, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0320/2019
20/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): fosmetpantotenate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0317/2019
20/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Trifarotene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0325/2019
20/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): birch bark extract, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0338/2019
20/03/2020 News and press releases: EMA Management Board – highlights of March 2020 meeting
19/03/2020 Withdrawn application: Keytruda, pembrolizumab, Date of withdrawal: 10/12/2019, Post-authorisation
19/03/2020 Other: Revised rules of procedure of the Management Board
19/03/2020 Periodic safety update single assessment: Amsacrine: List of nationally authorised medicinal products - PSUSA/00000199/201906
19/03/2020 Regulatory and procedural guideline: Notice to stakeholders - Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products
19/03/2020 Regulatory and procedural guideline: Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
19/03/2020 Brexit-related guidance for companies
19/03/2020 Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group, levetiracetam, Epilepsy, 04/12/2011, Generic, 13, Authorised
19/03/2020 Other: Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19
19/03/2020 Minutes: Minutes - PDCO minutes of the 15-18 October 2019 meeting
19/03/2020 Human medicines European public assessment report (EPAR): Deferiprone Lipomed, Deferiprone, Iron Overload, beta-Thalassemia, 19/09/2018, Generic, 2, Authorised
19/03/2020 Periodic safety update single assessment: Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201905
19/03/2020 Periodic safety update single assessment: Allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure): List of nationally authorised medicinal products - PSUSA/00010475/201907
19/03/2020 News and press releases: Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
19/03/2020 Agenda: Agenda for the 107th meeting of the Management Board
19/03/2020 Agenda: Agenda - CAT agenda of the 18-20 March 2020 meeting
18/03/2020 News and press releases: First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
18/03/2020 Template or form: Template letter of intent for request of qualification of novel methodologies to the Scientific Advice Working Party
18/03/2020 Periodic safety update single assessment: Human coagulation factor viii / human von willebrand factor : List of nationally authorised medicinal products - PSUSA/00001621/201810
18/03/2020 Periodic safety update single assessment: Bromocriptine : List of nationally authorised medicinal products - PSUSA/00000438/201810
18/03/2020 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 3, Authorised
18/03/2020 Periodic safety update single assessment: Nimodipine: List of nationally authorised medicinal products - PSUSA/00002166/201811
18/03/2020 Periodic safety update single assessment: Mitoxantrone: List of nationally authorised medicinal products - PSUSA/00002076/201906
18/03/2020 News and press releases: EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19
18/03/2020 Human medicines European public assessment report (EPAR): Edarbi, Azilsartan medoxomil, Hypertension, 07/12/2011, 8, Authorised
17/03/2020 Human medicines European public assessment report (EPAR): Hulio, adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic, 16/09/2018, Additional monitoring, Biosimilar, 4, Authorised
17/03/2020 Periodic safety update single assessment: Human coagulation factor IX: List of nationally authorised medicinal products - PSUSA/00001617/201907
17/03/2020 Agenda: Agenda - CVMP agenda of the 17-18 March 2020 meeting
17/03/2020 Periodic safety update single assessment: Methadone: List of nationally authorised medicinal products - PSUSA/00002004/201905
17/03/2020 Periodic safety update single assessment: Methadone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002004/201905
17/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate), clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke, 27/07/2009, Generic, 14, Authorised
17/03/2020 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 08/02/2018, Generic, 4, Authorised
17/03/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Madrid , Madrid, Spain, from 25/03/2020 to 27/03/2020
17/03/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Bucharest , Bucharest, Romania, from 01/04/2020 to 03/04/2020
17/03/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Prague , Prague, Czechia, from 22/04/2020 to 24/04/2020
16/03/2020 Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Gaucher Disease, 17/11/1997, 24, Authorised
16/03/2020 Paediatric Committee (PDCO)
16/03/2020 Work programme: PDCO work plan 2020
16/03/2020 Report: European Medicines Agency budget for 2020
16/03/2020 Report: Applications for new human medicines under evaluation by the CHMP: March 2020
16/03/2020 Human medicines European public assessment report (EPAR): Rixubis, nonacog gamma, Hemophilia B, 19/12/2014, 8, Authorised
13/03/2020 Template or form: Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product
13/03/2020 News and press releases: COVID-19: developers of medicines or vaccines to benefit from free scientific advice
13/03/2020 Other: CAT work plan 2020
13/03/2020 News and press releases: Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk
13/03/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020
13/03/2020 Other: European Medicines Agency’s privacy statement for the Information Centre
13/03/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2020
13/03/2020 Other: Records of data processing activity for managing the loaning of Information Centre material (public)
12/03/2020 Periodic safety update single assessment: Zaleplon: List of nationally authorised medicinal products - PSUSA/00003140/201907
12/03/2020 Periodic safety update single assessment: Levomethadone: List of nationally authorised medicinal products - PSUSA/00001855/201905
12/03/2020 Periodic safety update single assessment: Levomethadone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001855/201905
12/03/2020 Human medicines European public assessment report (EPAR): Zyprexa, olanzapine, Schizophrenia, Bipolar Disorder, 27/09/1996, 40, Authorised
12/03/2020 Human medicines European public assessment report (EPAR): Levetiracetam Hospira, levetiracetam, Epilepsy, 07/01/2014, Generic, 14, Authorised
12/03/2020 Human medicines European public assessment report (EPAR): Zyprexa Velotab, olanzapine, Schizophrenia, Bipolar Disorder, 03/02/2000, 29, Authorised
12/03/2020 Human medicines European public assessment report (EPAR): Amgevita, adalimumab, Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 21/03/2017, Additional monitoring, Biosimilar, 8, Authorised
11/03/2020 Veterinary medicines European public assessment report (EPAR): Zulvac SBV, Inactivated Schmallenberg virus, strain BH80/11-4, 06/02/2015, 3, Authorised
11/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya), clopidogrel (as hydrochloride), 20/09/2009, Generic, 11, Authorised
11/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel BGR (previously Zylagren), clopidogrel (as hydrogen sulphate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 21/09/2009, Generic, 17, Authorised
11/03/2020 News and press releases: COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020
11/03/2020 Newsletter: Human medicines highlights - March 2020
11/03/2020 Work programme: PRAC work plan 2020
11/03/2020 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, 33, Authorised
11/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 14, Authorised
11/03/2020 Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Clostridium Infections, 05/12/2011, 12, Authorised
11/03/2020 Agenda: Agenda - PRAC draft agenda of meeting 9-12 March 2020
11/03/2020 Human medicines European public assessment report (EPAR): Xagrid, Anagrelide, Thrombocythemia, Essential, 15/11/2004, 35, Authorised
11/03/2020 Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Prostatic Neoplasms, 21/06/2013, 26/04/2013, 15, Authorised
11/03/2020 Periodic safety update single assessment: Tolperisone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002991/201906
11/03/2020 Periodic safety update single assessment: Tolperisone: List of nationally authorised medicinal products - PSUSA/00002991/201906
10/03/2020 Periodic safety update single assessment: Moxifloxacin (systemic use): CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009231/201905
10/03/2020 Human medicines European public assessment report (EPAR): Zyllt, clopidogrel (as hydrogen sulphate), Peripheral Vascular Diseases, Stroke, Acute Coronary Syndrome, Myocardial Infarction, 28/09/2009, Generic, 13, Authorised
10/03/2020 Periodic safety update single assessment: Moxifloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00009231/201905
10/03/2020 Human medicines European public assessment report (EPAR): Cholestagel, colesevelam (as hydrochloride), Hypercholesterolemia, 09/03/2004, 21, Authorised
10/03/2020 Human medicines European public assessment report (EPAR): Azomyr, desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal, 15/01/2001, 43, Authorised
10/03/2020 Other: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive - 2019
10/03/2020 Human medicines European public assessment report (EPAR): Yargesa, miglustat, Gaucher Disease, 22/03/2017, Generic, 3, Authorised
10/03/2020 Minutes: Minutes of the CAT meeting 22-24 January 2020
10/03/2020 Human medicines European public assessment report (EPAR): Envarsus, tacrolimus, Graft Rejection, 18/07/2014, 7, Authorised
10/03/2020 Third European Medicines Agency-Medicines for Europe bilateral meeting , European Medicines Agency, Amsterdam, the Netherlands, from 23/03/2020 to 23/03/2020
10/03/2020 Minutes: Minutes of the CAT meeting 4-6 December 2019
10/03/2020 Committee for Advanced Therapies (CAT): 6-8 November 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 06/11/2019 to 08/11/2019