|
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,  , 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,  ,  , 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, , 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,  , , 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, , 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, , 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, , 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, , 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, ,  , 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,  , , 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, , , , 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, , 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, , , 4, Withdrawn |
|
25/03/2020 |
Human medicines European public assessment report (EPAR): Zalasta, olanzapine, Schizophrenia, Bipolar Disorder, 27/09/2007, , 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, , 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, , 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, , 15, Authorised |
|
24/03/2020 |
Human medicines European public assessment report (EPAR): Aripiprazole Accord, aripiprazole, Schizophrenia, Bipolar Disorder, 15/11/2015, , 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, , , 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, , , 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, , , 8, Authorised |
|
20/03/2020 |
Human medicines European public assessment report (EPAR): Ambrisentan Mylan, ambrisentan, Hypertension, Pulmonary, 20/06/2019, , 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, , , 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, , 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, , 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, , 6, Authorised |
|
19/03/2020 |
Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group, levetiracetam, Epilepsy, 04/12/2011, , 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, , 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, , , , 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, , , 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
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