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29/01/2021 COVID-19 treatments: authorised
29/01/2021 News and press releases: EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
29/01/2021 Human medicines European public assessment report (EPAR): Bosulif, bosutinib (as monohydrate), Leukemia, Myeloid, 27/03/2013, Additional monitoring, Conditional approval, 20, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Lacosamide UCB, lacosamide, Epilepsies, Partial, 26/08/2019, 1, Authorised
29/01/2021 Press briefing on EU recommendation for COVID-19 Vaccine AstraZeneca , Virtual meeting, from 29/01/2021 to 29/01/2021
29/01/2021 Provision of field efficacy studies in support of marketing authorisation applications for immunological veterinary medicinal products and on indications for veterinary vaccines
29/01/2021 Scientific guideline: Draft concept paper on the provision of field efficacy studies in support of marketing authorisation applications for immunological veterinary medicinal products and on indications for veterinary vaccines
29/01/2021 Data requirements for multi-strain dossiers for Inactivated vaccines against avian influenza (AI), blue tongue (BT) and foot-and-mouth disease (FMD)
29/01/2021 Scientific guideline: Draft concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD)
29/01/2021 Scientific guideline: Draft concept paper for the development of a guideline on data requirements for vaccine platform technology master files (PTMF)
29/01/2021 Data requirements for vaccine platform technology master files (PTMF)
29/01/2021 Scientific guideline: Draft concept paper for the development of a guideline on data requirements for vaccine antigen master files (VAMF)
29/01/2021 Data requirements for for vaccine antigen master files (VAMF)
29/01/2021 Data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances
29/01/2021 Scientific guideline: Draft concept paper for the development of a guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances
29/01/2021 Human medicines European public assessment report (EPAR): Gazyvaro, Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, 22/07/2014, Orphan, Additional monitoring, 11, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Halimatoz, adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 8, Withdrawn
29/01/2021 Human medicines European public assessment report (EPAR): Imatinib Teva, imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma, 07/01/2013, Generic, 15, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Entecavir Accord, Entecavir, Hepatitis B, Chronic, 25/09/2017, Generic, 3, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Yttriga, yttrium (90Y) chloride, Radionuclide Imaging, 19/01/2006, 10, Authorised
29/01/2021 Human medicines European public assessment report (EPAR): Potactasol, topotecan, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 06/01/2011, Generic, 8, Authorised
29/01/2021 ICH Q3D Elemental impurities
29/01/2021 Overview of comments: Overview of comments received on ICH guideline Q3D(R2) on elemental impurities (EMA/CHMP/ICH/353369/2013)
29/01/2021 Agenda: CHMP ORGAM minutes for the meeting on 15 June 2020
29/01/2021 Template or form: Confidentiality undertaking for observers
29/01/2021 News and press releases: First COVID-19 vaccine safety update published
29/01/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 28 January 2021
29/01/2021 Data Monitoring Committees issues
28/01/2021 Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, 18/10/2013, Orphan, Additional monitoring, Exceptional circumstances, 13, Authorised
28/01/2021 Orphan designation: Clofazimine for the: Treatment of nontuberculous mycobacterial lung disease, 21/08/2019, Positive
28/01/2021 Veterinary medicines European public assessment report (EPAR): Advocate, imidacloprid, moxidectin, 02/04/2003, 22, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Zynteglo, Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia, 29/05/2019, Orphan, Accelerated assessment, Additional monitoring, Conditional approval, 3, Authorised
28/01/2021 News and press releases: Clarification of Comirnaty dosage interval
28/01/2021 Human medicines European public assessment report (EPAR): Relistor, methylnaltrexone bromide, Opioid-Related Disorders, Constipation, 01/07/2008, 17, Authorised
28/01/2021 Newsletter: Veterinary Medicines Regulation highlights - Issue 3
28/01/2021 Herbal medicinal product: Caryophylii floris aetheroleum, Caryophylii floris aetheroleum, F: Assessment finalised
28/01/2021 Human medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency, 26/05/2016, Orphan, Additional monitoring, 5, Authorised
28/01/2021 Human medicines European public assessment report (EPAR): Telmisartan Teva Pharma, telmisartan, Hypertension, 03/10/2011, Generic, 9, Authorised
28/01/2021
28/01/2021 Periodic safety update single assessment: Diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed): List of nationally authorised medicinal products - PSUSA/00001128/202005
28/01/2021 Periodic safety update single assessment: ciprofloxacin hydrochloride / dexamethasone acetate (ear drops, suspension): List of nationally authorised medicinal products - PSUSA/00010012/202004
28/01/2021 Regulatory and procedural guideline: Dossier requirements for nationally authorised porducts (referral, PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device
28/01/2021 Agenda: CHMP ORGAM agenda for the meeting on 15 June 2020
28/01/2021 Other: Information Technology Directors Group - List of nominated members (alphabetically by country)
27/01/2021 Human medicines European public assessment report (EPAR): Darunavir Krka, darunavir, HIV Infections, 26/01/2018, Generic, 6, Authorised
27/01/2021 Periodic safety update single assessment: Clarithromycin: List of nationally authorised medicinal products - PSUSA/00000788/202004
27/01/2021 Periodic safety update single assessment: Clarithromycin: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000788/202004
27/01/2021 Periodic safety update single assessment: Piroxicam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002438/202004
27/01/2021 Periodic safety update single assessment: Piroxicam: List of nationally authorised medicinal products - PSUSA/00002438/202004
27/01/2021 Human medicines European public assessment report (EPAR): Ibandronic Acid Teva, ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, Osteoporosis, Postmenopausal, 17/09/2010, Generic, 10, Authorised
27/01/2021 Direct healthcare professional communication (DHPC): Shortage of Nucala (mepolizumab) Pre-Filled Pen (EU/1/15/1043/003, EU/1/15/1043/004), Active substance: Mepolizumab, DHPC type: Medicine shortage, Last updated: 27/01/2021
27/01/2021 Human medicines European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan, acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome, Myocardial Infarction, 09/01/2020, Generic, 2, Authorised
27/01/2021 Overview of comments: Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082 - Overview of comments
27/01/2021 Human medicines European public assessment report (EPAR): Zostavax, varicella-zoster virus (live, attenuated), Herpes Zoster, Immunization, 19/05/2006, 29, Authorised
27/01/2021 Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, 22/11/2018, Additional monitoring, 5, Authorised
27/01/2021 Committee for Medicinal Products for Human Use (CHMP): 25-28 May 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 25/05/2020 to 28/05/2020
27/01/2021 Minutes: CHMP ORGAM minutes for the meeting on 18 May 2020
27/01/2021 Human medicines European public assessment report (EPAR): Lojuxta, Lomitapide, Hypercholesterolemia, 31/07/2013, Additional monitoring, Exceptional circumstances, 13, Authorised
27/01/2021 Agenda: Agenda - PDCO agenda of the 26-29 January 2021 meeting
27/01/2021 Agenda: CHMP ORGAM agenda for the meeting on 18 May 2020
27/01/2021 Agenda: CHMP ORGAM agenda for the meeting on 20 April 2020
27/01/2021 Minutes: CHMP ORGAM minutes for the meeting on 20 April 2020
27/01/2021 Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan, hydrochlorothiazide, Essential Hypertension, 13/03/2013, Generic, 12, Authorised
27/01/2021 Report: Meeting summary - PCWP/HCPWP meeting with all eligible organisations: COVID-19 pandemic update
27/01/2021 Minutes: CHMP ORGAM minutes for the meeting on 16 March 2020
27/01/2021 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, Additional monitoring, 4, Authorised
26/01/2021 Funding
26/01/2021 Agenda: Agenda - CHMP agenda of the 25-29 January 2021 meeting
26/01/2021 Other: Assent / Informed consent guidance for paediatric clinical trials with medicinal products in Europe
26/01/2021 Human medicines European public assessment report (EPAR): Darzalex, Daratumumab, Multiple Myeloma, 20/05/2016, Orphan, Accelerated assessment, Additional monitoring, 15, Authorised
26/01/2021 Human medicines European public assessment report (EPAR): Invanz, ertapenem sodium, Community-Acquired Infections, Streptococcal Infections, Staphylococcal Infections, Gram-Negative Bacterial Infections, Surgical Wound Infection, Pneumonia, Bacterial, 18/04/2002, 23, Authorised
26/01/2021 Veterinary medicines European public assessment report (EPAR): Onsior, robenacoxib, 16/12/2008, 14, Authorised
25/01/2021 Periodic safety update single assessment: Nicergoline: List of nationally authorised medicinal products - PSUSA/00002150/202005
25/01/2021 Periodic safety update single assessment: Chlorpromazine: List of nationally authorised medicinal products - PSUSA/00000715/202005
25/01/2021 Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, Orphan, Accelerated assessment, Additional monitoring, 4, Authorised
25/01/2021 Human medicines European public assessment report (EPAR): Ocaliva, Obeticholic acid, Liver Cirrhosis, Biliary, 12/12/2016, Orphan, Additional monitoring, Conditional approval, 8, Authorised
25/01/2021 Orphan designation: 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) for the: Treatment of mantle cell lymphoma, 13/11/2019, Positive
25/01/2021 Human medicines European public assessment report (EPAR): Tecartus, 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, Lymphoma, Mantle-Cell, 14/12/2020, Orphan, Additional monitoring, Conditional approval, Authorised
25/01/2021 News and press releases: Cyberattack on EMA - update 6
25/01/2021 Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein for the: Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive
25/01/2021 Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, 07/01/2021, Orphan, Additional monitoring, Exceptional circumstances, Authorised
25/01/2021 Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 18/12/2018, 3, Authorised
25/01/2021 Template or form: Innovation Task Force (ITF) briefing meeting request form
25/01/2021 Report: Medicinal products for human use: monthly figures - December 2020
25/01/2021 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm GmbH, clopidogrel, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke, 28/07/2009, Generic, 12, Withdrawn
25/01/2021 Other: European Medicines Agency’s privacy statement for user research for the design of the Union Product Database
25/01/2021 Other: Records of data processing activity for user research for the design of the Union Product Database
25/01/2021 Other: Timetable accelerated assessment request for initial marketing authorisation applications
25/01/2021 Paediatric Committee (PDCO): 10-13 November 2020 , Virtual meeting, from 10/11/2020 to 13/11/2020
25/01/2021 Minutes: Minutes - PDCO minutes of the 10-13 November 2020 meeting
25/01/2021 Work programme: CVMP work plan 2021
25/01/2021 Periodic safety update single assessment: Ketobemidone: List of nationally authorised medicinal products - PSUSA/0001807/202005
25/01/2021 Orphan designation: Oxytocin for the: Treatment of Prader-Willi syndrome, 29/07/2014, Positive
25/01/2021 Veterinary medicines European public assessment report (EPAR): Velactis, cabergoline, 09/12/2015, 1, Withdrawn
25/01/2021 Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, 18/02/2016, 10, Authorised
25/01/2021 Report: European Medicines Agency budget for 2021
25/01/2021 Veterinary medicines European public assessment report (EPAR): Profender, emodepside, praziquantel, 27/07/2005, 19, Authorised
22/01/2021 Report: Summary report - EU big data stakeholder virtual forum
22/01/2021 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 8-11 December 2020
22/01/2021 Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic, 27/09/2017, Additional monitoring, 9, Authorised
22/01/2021 Periodic safety update single assessment: Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004
22/01/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021
22/01/2021 Periodic safety update single assessment: Deoxycholic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/202004
22/01/2021 Periodic safety update single assessment: Deoxycholic acid: List of nationally authorised medicinal products - PSUSA/00010525/202004
22/01/2021 Human medicines European public assessment report (EPAR): Xofluza, Baloxavir marboxil, Influenza, Human, 07/01/2021, Additional monitoring, Authorised
22/01/2021 Pharmaceutical industry
22/01/2021 Report: European Medicines Agency’s interaction with industry stakeholders - Biennial report 2018-19
22/01/2021 Human medicines European public assessment report (EPAR): ViraferonPeg, peginterferon alfa-2b, Hepatitis C, Chronic, 28/05/2000, 36, Withdrawn
22/01/2021 Periodic safety update single assessment: Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202005
22/01/2021 Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Psoriasis, 10/11/2017, Additional monitoring, 5, Authorised
22/01/2021 Periodic safety update single assessment: Formoterol : List of nationally authorised medicinal products - PSUSA/00001469/202005
22/01/2021 Human medicines European public assessment report (EPAR): Symkevi, tezacaftor, ivacaftor, Cystic Fibrosis, 31/10/2018, Orphan, Additional monitoring, 7, Authorised
21/01/2021 Periodic safety update single assessment: Mometasone: List of nationally authorised medicinal products - PSUSA/00002085/202005
21/01/2021 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight, 26/03/2015, Additional monitoring, 18, Authorised
21/01/2021 Agenda: Agenda - Fourth EMA-Medicines for Europe bilateral meeting
21/01/2021 European Medicines Agency and Medicines for Europe fourth bilateral meeting , Virtual meeting, from 26/01/2021 to 26/01/2021
21/01/2021 Other: Policy 78: EMA environmental policy
21/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Brazikumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0397/2017
21/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0321/2018
21/01/2021 Periodic safety update single assessment: Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/202006
21/01/2021 Periodic safety update single assessment: Dexpanthenol xylometazoline: List of nationally authorised medicinal products - PSUSA/00010030/202005
21/01/2021 Periodic safety update single assessment: Peppermint oil: List of nationally authorised medicinal products - PSUSA/00010436/202005
21/01/2021 Human medicines European public assessment report (EPAR): Roclanda, Latanoprost, Netarsudil mesilate, Glaucoma, Open-Angle, Ocular Hypertension, 07/01/2021, Additional monitoring, Authorised
21/01/2021 Fifth industry stakeholder platform on research and development support , Virtual meeting, from 16/11/2020 to 16/11/2020
21/01/2021 News and press releases: Veterinary medicines: highlights of 2020
21/01/2021 Report: Veterinary medicines highlights 2020
21/01/2021 Report: Human medicines highlights 2020
21/01/2021 News and press releases: Human medicines: highlights of 2020
21/01/2021 Periodic safety update single assessment: Gadoteric acid (intra articular formulation): List of nationally authorised medicinal products - PSUSA/00001505/202004
20/01/2021 News and press releases: Extra dose from vials of Comirnaty COVID-19 vaccine
20/01/2021 Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 16, Authorised
20/01/2021 Periodic safety update single assessment: Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/202005
20/01/2021 Periodic safety update single assessment: Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/202005
20/01/2021 Other: Timetable: Annual renewal application of conditional marketing authorisation
20/01/2021 Other: Timetable: Annual reassessment
20/01/2021 Other: Timetable: Annual renewal application of conditional marketing authorisation - ATMP
20/01/2021 Other: Timetable: Marketing authorisation renewal application - ATMP
20/01/2021 Other: Timetable: Annual reassessment - ATMP
20/01/2021 Other: Timetable: Marketing authorisation renewal application
20/01/2021 Periodic safety update single assessment: Ticlopidine: List of nationally authorised medicinal products - PSUSA/00002952/202005
20/01/2021 Leaflet: Info-card for patients: Reporting suspected side effects of medicines in patients with COVID-19
20/01/2021 Periodic safety update single assessment: valsartan, hydrochlorothiazide / valsartan: List of nationally authorised medicinal products - PSUSA/00010396/202004
20/01/2021 Periodic safety update single assessment: Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/202005
19/01/2021 Periodic safety update single assessment: Mifepristone / misoprostol: List of nationally authorised medicinal products - PSUSA/00010378/202005
19/01/2021 Periodic safety update single assessment: Gadopentetic acid: List of nationally authorised medicinal products - PSUSA/00001504/202004
19/01/2021 Human medicines European public assessment report (EPAR): Ryzodeg, insulin aspart, insulin degludec, Diabetes Mellitus, 21/01/2013, 12, Authorised
19/01/2021 Periodic safety update single assessment: Amfepramone: List of nationally authorised medicinal products - PSUSA/00000138/202006
19/01/2021 Newsletter: News bulletin for small and medium-sized enterprises - Issue 51
19/01/2021 Human medicines European public assessment report (EPAR): Roteas, edoxaban tosilate, Stroke, Venous Thromboembolism, 19/04/2017, Additional monitoring, 8, Authorised
19/01/2021 Agenda: Agenda - CAT agenda of the 20-22 January 2021 meeting
19/01/2021 Agenda: Agenda - CVMP agenda of the 19-21 January 2021 meeting
19/01/2021 News and press releases: Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines
18/01/2021 Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Gaucher Disease, 17/11/1997, 25, Authorised
18/01/2021 Human medicines European public assessment report (EPAR): Qutavina, teriparatide, Osteoporosis, 27/08/2020, Biosimilar, Withdrawn
18/01/2021 Human medicines European public assessment report (EPAR): Ovitrelle, choriogonadotropin alfa, Anovulation, Reproductive Techniques, Assisted, Infertility, Female, 02/02/2001, 20, Authorised
18/01/2021 Periodic safety update single assessment: Simvastatin: List of nationally authorised medicinal products - PSUSA/00002709/202004
18/01/2021 Agenda: Agenda - COMP agenda of the 19-21 January 2021 meeting
18/01/2021 Withdrawn application: Puldysa, idebenone, Date of withdrawal: 28/10/2020, Initial authorisation
18/01/2021 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: November 2020
18/01/2021 Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2020 , Virtual meeting, from 03/11/2020 to 05/11/2020
18/01/2021 Fifth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines , Virtual meeting, from 03/12/2020 to 03/12/2020
18/01/2021 Periodic safety update single assessment: Teicoplanin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0025
18/01/2021 Other: Organisation chart: Information Management
18/01/2021 Periodic safety update single assessment: Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025
18/01/2021 Periodic safety update single assessment: Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005
18/01/2021 Periodic safety update single assessment: Ivabradine / metoprolol : List of nationally authorised medicinal products - PSUSA/00010381/202004
18/01/2021 Periodic safety update single assessment: Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004
18/01/2021 Periodic safety update single assessment: Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004
18/01/2021 Human medicines European public assessment report (EPAR): Clopidogrel TAD, clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 12, Authorised
18/01/2021 Periodic safety update single assessment: Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/202004
18/01/2021 Periodic safety update single assessment: Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004
16/01/2021 Human medicines European public assessment report (EPAR): Jetrea, ocriplasmin, Retinal Diseases, 13/03/2013, 15, Authorised
15/01/2021 Human medicines European public assessment report (EPAR): Tyverb, lapatinib, Breast Neoplasms, 10/06/2008, 31, Authorised
15/01/2021 Periodic safety update single assessment: Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005
15/01/2021 Committee meeting report: COMP meeting report on the review of applications for orphan designation: September 2020
15/01/2021 Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 31, Authorised
15/01/2021 Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Diabetes Mellitus, 20/01/2013, 14, Authorised
15/01/2021 News and press releases: Cyberattack on EMA - update 5
15/01/2021 Agenda: Agenda - HMPC agenda of the 11-13 January 2021 meeting
15/01/2021 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
15/01/2021 Human medicines European public assessment report (EPAR): Brintellix, Vortioxetine, Depressive Disorder, Major, 18/12/2013, 16, Authorised
15/01/2021 Human medicines European public assessment report (EPAR): INOmax, Nitric oxide, Hypertension, Pulmonary, Respiratory Insufficiency, 01/08/2001, 22, Authorised
15/01/2021 Human medicines European public assessment report (EPAR): Grepid, clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 27/07/2009, Generic, 21, Authorised
15/01/2021 Minutes: Minutes of the CHMP meeting 14-17 September 2020
15/01/2021 Orphan designation: dimethyl fumarate for the: Adjunctive treatment in haematopoietic cell transplantation, 21/03/2018, Positive
15/01/2021 Other: Questions and answers on signal management
15/01/2021 Template or form: Application form for the involvement of healthcare professionals’ organisations in the activities of the European Medicines Agency
14/01/2021 Human medicines European public assessment report (EPAR): Sebivo, telbivudine, Hepatitis B, Chronic, 24/04/2007, 20, Withdrawn
14/01/2021 Coronavirus disease (COVID-19)
14/01/2021 Treatments and vaccines for COVID-19
14/01/2021 National competent authorities (human)
14/01/2021 Human medicines European public assessment report (EPAR): Mayzent, Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting, 13/01/2020, Additional monitoring, 4, Authorised
14/01/2021 Veterinary medicines European public assessment report (EPAR): Osurnia, betamethasone acetate, terbinafine, florfenicol, 31/07/2014, 10, Authorised
14/01/2021 Human medicines European public assessment report (EPAR): Holoclar, ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases, 17/02/2015, Orphan, Additional monitoring, Conditional approval, 7, Authorised
14/01/2021 Human medicines European public assessment report (EPAR): Valdoxan, Agomelatine, Depressive Disorder, Major, 19/02/2009, 22, Authorised
14/01/2021 Human medicines European public assessment report (EPAR): Thymanax, Agomelatine, Depressive Disorder, Major, 19/02/2009, 18/11/2006, 22, Authorised
14/01/2021 Obtaining an EU marketing authorisation, step-by-step
14/01/2021 Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union
14/01/2021 Leaflet: EU-M4all - Promoting parallel application for EU-M4all opinion and centralised marketing authorisation procedure
14/01/2021 Regulatory and procedural guideline: Draft guidance - Parallel application for EU-M4all (Article 58) opinion and centralised marketing authorisation procedure
14/01/2021 EPAR - Procedural steps taken before authorisation: Sebivo : EPAR - Procedural steps taken before authorisation
14/01/2021 EPAR - All authorised presentations: Sebivo : EPAR - All Authorised presentations
14/01/2021 EPAR - Scientific Discussion: Sebivo : EPAR - Scientific Discussion
13/01/2021 Human medicines European public assessment report (EPAR): Phesgo, pertuzumab, trastuzumab, Breast Neoplasms, 21/12/2020, Additional monitoring, Authorised
13/01/2021 Healthcare Professionals' Working Party
13/01/2021 Agenda: Agenda - European Medicines Agency and European Healthcare Distribution Association (GIRP) bilateral meeting
13/01/2021 European Medicines Agency and European Healthcare Distribution Association (GIRP) bilateral meeting , Virtual meeting, from 18/01/2021 to 18/01/2021
13/01/2021 Other: Decision of the Executive Director on rules governing the secondment of national experts to the EMA
13/01/2021 Dose review and adjustment of established veterinary antibiotics in the context summary of product characteristic (SPC) harmonisation
13/01/2021 Scientific guideline: Reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC harmonisation - First version
13/01/2021 Overview of comments: Overview of comments received on ''Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation"
13/01/2021 Report: Highlight report - Fifth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines
13/01/2021 Newsletter: Human medicines highlights - January 2021
13/01/2021 Generic and hybrid applications
13/01/2021 Risk management plans (RMP) in post-authorisation phase: questions and answers
13/01/2021 Post-authorisation efficacy studies: questions and answers
13/01/2021 Risk management
13/01/2021 Template or form: Marketing status reporting
13/01/2021 Template or form: Template to be used to notify the European Medcines Agency and concerned Member States of 'withdrawn products'
13/01/2021 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications
13/01/2021 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
13/01/2021 Template or form: Summary of main efficacy results - Module 5.3.5 of the dossier administrative validation checklist for initial marketing authorisation applications by applicants
12/01/2021 Regulatory and procedural guideline: Draft EudraVigilance access policy for medicines for veterinary use - Revision 2
12/01/2021 Public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU , Virtual meeting, 13:00-15:15 CET, from 08/01/2021 to 08/01/2021
12/01/2021 News and press releases: Cyberattack on EMA - update 4
12/01/2021 Orphan designation: rasagiline for the: Treatment of Duchenne muscular dystrophy, 28/06/2019, Withdrawn
12/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0094/2014
12/01/2021 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
12/01/2021 News and press releases: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
11/01/2021 Regulatory and procedural guideline: Recommended submission dates for veterinary medicinal products
11/01/2021 Veterinary medicines European public assessment report (EPAR): Sileo, dexmedetomidine hydrochloride, 10/06/2015, 8, Authorised
11/01/2021 Agenda: Agenda - PRAC draft agenda of meeting 11-14 January 2021
11/01/2021 Other: Records of data processing activity relating to Slido’s audience interaction tool (public)
11/01/2021 Human medicines European public assessment report (EPAR): Panretin, alitretinoin, Sarcoma, Kaposi, 11/10/2000, 17, Withdrawn
11/01/2021 Periodic safety update single assessment: Flucloxacillin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001402/202003
11/01/2021 Periodic safety update single assessment: Flucloxacillin: List of nationally authorised medicinal products - PSUSA/00001402/202003
11/01/2021 Orphan designation: Tetrahydrobiopterin for the: Treatment of hyperphenylalaninaemia, 08/06/2004, Withdrawn
11/01/2021 Report: Applications for new human medicines under evaluation by the CHMP: January 2021
11/01/2021 Human medicines European public assessment report (EPAR): BeneFIX, Nonacog alfa, Hemophilia B, 27/08/1997, 40, Authorised
08/01/2021 Other: European Medicines Agency’s privacy statement for the use of audience interaction tool Slido
08/01/2021 Minutes: Minutes of the PRAC meeting 26-29 October 2020
08/01/2021 Human medicines European public assessment report (EPAR): Prevenar 13, Pneumococcal polysaccharide serotype 1, 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, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections, Immunization, 09/12/2009, 40, Authorised
08/01/2021 Periodic safety update single assessment: Ethosuximide: List of nationally authorised medicinal products - PSUSA/00001316/202003
08/01/2021 Periodic safety update single assessment: Ethosuximide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00001316/202003
08/01/2021 Other: Comirnaty - Product Information as approved by the CHMP on 8 January 2021, pending endorsement by the European Commission
08/01/2021 Human medicines European public assessment report (EPAR): Fintepla, Fenfluramine hydrochloride, Epilepsies, Myoclonic, 18/12/2020, Orphan, Additional monitoring, Authorised
08/01/2021 Orphan designation: Fenfluramine hydrochloride for the: Treatment of Dravet syndrome, 18/12/2013, Positive
07/01/2021 Veterinary medicines European public assessment report (EPAR): Rabitec, attenuated live rabies vaccine virus, strain SPBN GASGAS, 01/12/2017, 3, Authorised
07/01/2021 Minutes: Minutes of the CVMP meeting of 3-5 November 2020
07/01/2021 Minutes: Minutes of the CHMP meeting 9-12 November 2020