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31/03/2020 Regulatory science strategy
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 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 Other: Organisation chart: Human Medicines
31/03/2020 Human Medicines
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 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 Human medicines European public assessment report (EPAR): Grasustek, pegfilgrastim, Neutropenia, 20/06/2019, Additional monitoring, Biosimilar, 1, Authorised
31/03/2020 Human medicines European public assessment report (EPAR): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/xxxxx (H3N2)-like strain (reassortant used)/ A/xxxxx H1N1- like strain (reassortant used)/ B/xxxxx (Yamagata Lineage) – like strain (reassortant used)/ B/xxxxx (Victoria Lineage) – like strain (reassortant used), Influenza, Human, 12/12/2018, Additional monitoring, 4, Authorised
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): Atripla, efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 13/12/2007, 33, Authorised
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 Opinions and letters of support on the qualification of novel methodologies for medicine development
30/03/2020 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm, clopidogrel hydrogen sulphate, Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke, 18/02/2015, Generic, 9, Authorised
30/03/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCP, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), 23/02/2005, 13, Authorised
30/03/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains) / attenuated Chlamydophila felis (905 strain) / attenuated feline panleucopenia virus (PLI IV), 22/02/2005, 13, 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): Avacopan, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0360/2019
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 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh FeLV, Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 23/02/2005, 11, Authorised
30/03/2020 Veterinary medicines European public assessment report (EPAR): Eurican Herpes 205, Canine herpesvirus (F205 strain) antigens, 26/03/2001, 10, Authorised
30/03/2020 Veterinary medicines European public assessment report (EPAR): Purevax RCP FeLV, Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline Calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 23/02/2005, 11, Authorised
30/03/2020 Veterinary medicines European public assessment report (EPAR): Purevax FeLV, feline leukaemia virus recombinant canarypox virus (vCP97), 13/04/2000, 8, Authorised
30/03/2020 Veterinary medicines European public assessment report (EPAR): Purevax RC, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) / inactivated feline calicivirosis antigens (FCV 431 and G1 strains), 23/02/2005, 12, Authorised
30/03/2020 Human medicines European public assessment report (EPAR): Tasigna, nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 19/11/2007, 36, Authorised
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 Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers on 'Information on nitrosamines for marketing authorisation holders'
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 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration
27/03/2020 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms
27/03/2020 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations
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 Summary of opinion: Intelence, etravirine, 26/03/2020, Positive
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 Summary of opinion: Ruconest, conestat alfa, 26/03/2020, Positive
27/03/2020 Minutes: Minutes of the COMP meeting 3-5 December 2019
27/03/2020 Withdrawn application: Doxorubicin Hydrochloride Tillomed, doxorubicin, Date of withdrawal: 02/03/2020, Initial authorisation
27/03/2020 News and press releases: Restrictions in use of cyproterone due to meningioma risk
27/03/2020 Summary of opinion: Cosentyx, secukinumab, 26/03/2020, Positive
27/03/2020 News and press releases: Recommendations to restrict use of fosfomycin antibiotics
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 Human medicines European public assessment report (EPAR): Briviact (in Italy: Nubriveo), Brivaracetam, Epilepsy, 13/01/2016, Additional monitoring, 8, Authorised
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 Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), PM: decision on the application for modification of an agreed PIP, P/0349/2019
27/03/2020 Summary of opinion: Pretomanid FGK, pretomanid, 26/03/2020, Positive
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 Human medicines European public assessment report (EPAR): Prevenar 13, pneumococcal polysaccharide serotype 1 / pneumococcal polysaccharide serotype 14 / pneumococcal polysaccharide serotype 18C / pneumococcal polysaccharide serotype 19A, pneumococcal polysaccharide serotype 19F / pneumococcal polysaccharide serotype 23F / pneumococcal polysaccharide serotype 3 / pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6A, pneumococcal polysaccharide serotype 6B / pneumococcal polysaccharide serotype 7F / pneumococcal polysaccharide serotype 9V protein, Pneumococcal Infections, Immunization, 09/12/2009, 37, Authorised
26/03/2020 Opinion/decision on a Paediatric investigation plan (PIP): Anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0305/2019
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 Opinion/decision on a Paediatric investigation plan (PIP): Fevipiprant, PM: decision on the application for modification of an agreed PIP, P/0341/2019
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): MabThera, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, 02/06/1998, 50, Authorised
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 Human medicines European public assessment report (EPAR): Prevymis, Letermovir, Cytomegalovirus Infections, 08/01/2018, Orphan, Additional monitoring, 6, Authorised
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 Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, Orphan, Accelerated assessment, Additional monitoring, 2, Authorised
25/03/2020 Report: 10-year annual report on MUMS/limited market scheme for veterinary medicines
25/03/2020 Requesting a minor use / minor species (MUMS) / limited market classification
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 Minor use / minor species and limited markets
25/03/2020 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight, 26/03/2015, Additional monitoring, 15, Authorised
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): Vaxelis, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus, Poliomyelitis, Tetanus, Diphtheria, Whooping Cough, Hepatitis B, 15/02/2016, Additional monitoring, 7, Authorised
25/03/2020 Veterinary medicines European public assessment report (EPAR): Credelio, lotilaner, 23/04/2017, 4, Authorised
25/03/2020 Human medicines European public assessment report (EPAR): Fasturtec, rasburicase, Hyperuricemia, 23/02/2001, 25, Authorised
25/03/2020 Human medicines European public assessment report (EPAR): Xeristar, duloxetine, Anxiety Disorders, Depressive Disorder, Major, Diabetic Neuropathies, 17/12/2004, 29, Authorised
25/03/2020 Human medicines European public assessment report (EPAR): Ecalta, anidulafungin, Candidiasis, 20/09/2007, 21, 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): Cuprymina, copper (64Cu) chloride, Radionuclide Imaging, 23/08/2012, 7, Authorised
24/03/2020 Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone, Neoplasm Metastasis, 13/07/2011, 19, Authorised
24/03/2020 Human medicines European public assessment report (EPAR): Rezolsta, darunavir, cobicistat, HIV Infections, 19/11/2014, 10, Authorised
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): Suliqua, insulin glargine, lixisenatide, Diabetes Mellitus, Type 2, 11/01/2017, Additional monitoring, 5, Authorised
24/03/2020 Paediatric investigation plans: questions and answers
24/03/2020 Regulatory and procedural guideline: Guidance on paediatric submissions
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): Aripiprazole Accord, aripiprazole, Schizophrenia, Bipolar Disorder, 15/11/2015, Generic, 9, 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
24/03/2020 Human medicines European public assessment report (EPAR): BiResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 9, Authorised
24/03/2020 Human medicines European public assessment report (EPAR): Votrient, pazopanib, Carcinoma, Renal Cell, 14/06/2010, 23, 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): Cubicin, daptomycin, Gram-Positive Bacterial Infections, Bacteremia, Soft Tissue Infections, Endocarditis, Bacterial, 19/01/2006, 32, Authorised
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): recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0310/2019
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
23/03/2020 Human medicines European public assessment report (EPAR): Tracleer, bosentan monohydrate, Scleroderma, Systemic, Hypertension, Pulmonary, 14/05/2002, 38, Authorised
23/03/2020 Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, Orphan, Additional monitoring, 8, Authorised
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 Human medicines European public assessment report (EPAR): Imraldi, adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Arthritis, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic, 24/08/2017, Additional monitoring, Biosimilar, 11, Authorised
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 Summary of opinion: Lydaxx, tulathromycin, 18/03/2020, Positive
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 Human medicines European public assessment report (EPAR): Zavicefta, Ceftazidime, avibactam, Pneumonia, Bacterial, Soft Tissue Infections, Pneumonia, Urinary Tract Infections, Gram-Negative Bacterial Infections, 23/06/2016, Additional monitoring, 9, Authorised
20/03/2020 News and press releases: EMA Management Board – highlights of March 2020 meeting
20/03/2020 Clinical Trial Regulation
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 Human medicines European public assessment report (EPAR): Skyrizi, Risankizumab, Psoriasis, 26/04/2019, Additional monitoring, 2, Authorised
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): Cinacalcet Mylan, cinacalcet hydrochloride, Hyperparathyroidism, Secondary, Hypercalcemia, 19/11/2015, Generic, 6, Authorised
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 Human medicines European public assessment report (EPAR): Spinraza, nusinersen sodium, Muscular Atrophy, Spinal, 30/05/2017, Orphan, Accelerated assessment, Additional monitoring, 9, Authorised
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 Human medicines European public assessment report (EPAR): Liprolog, insulin lispro, Diabetes Mellitus, 01/08/2001, 27, Authorised
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): Humalog, insulin lispro, Diabetes Mellitus, 30/04/1996, 31, Authorised
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 Human medicines European public assessment report (EPAR): Colobreathe, Colistimethate sodium, Cystic Fibrosis, 13/02/2012, 11, Authorised
18/03/2020 Periodic safety update single assessment: Mitoxantrone: List of nationally authorised medicinal products - PSUSA/00002076/201906