What's new

RSS
Date Content
12/11/2019 Report: Annual Activity Report 2018
12/11/2019 Human medicines European public assessment report (EPAR): Rebetol, Ribavirin, Hepatitis C, Chronic, 06/05/1999, 36, Authorised
12/11/2019 News and press releases: Regulators’ advice can make a difference for faster patient access to highly innovative therapies
12/11/2019 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, 8, Authorised
12/11/2019 Standard Operating Procedure - SOP: Standard operating procedure for review of orphan designation at the time of granting/varying a marketing authorisation
12/11/2019 Agenda: Agenda - PDCO agenda of the 12-15 November 2019 meeting
12/11/2019 Human medicines European public assessment report (EPAR): Wakix, pitolisant, Narcolepsy, 31/03/2016, Orphan, Additional monitoring, 7, Authorised
11/11/2019 Human medicines European public assessment report (EPAR): Temozolomide Teva, temozolomide, Glioma, Glioblastoma, 28/01/2010, Generic, 18, Authorised
11/11/2019 Human medicines European public assessment report (EPAR): Pantoloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 17, Authorised
11/11/2019 Human medicines European public assessment report (EPAR): Moventig, naloxegol oxalate, Constipation, Opioid-Related Disorders, 07/12/2014, 11, Authorised
11/11/2019 Human medicines European public assessment report (EPAR): Rilutek, Riluzole, Amyotrophic Lateral Sclerosis, 10/06/1996, 27, Authorised
11/11/2019 Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Hemophilia A, 04/01/2017, Additional monitoring, 6, Authorised
11/11/2019 Human medicines European public assessment report (EPAR): Aflunov, influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human, Immunization, Disease Outbreaks, 28/11/2010, 12, Authorised
11/11/2019 News and press releases: ‘Regulatory science to 2025’: live broadcast of post-consultation workshop
11/11/2019 Paediatric Committee (PDCO): 15-18 October 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 15/10/2019 to 18/10/2019
11/11/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 15-18 October 2019
11/11/2019 Agenda: CHMP ORGAM agenda for the meeting on 7 October 2019
11/11/2019 Agenda: Agenda - CHMP agenda of the 11-14 November 2019 meeting
08/11/2019 Medicine QA: Responses to questions raised at the Bravecto petition hand over
08/11/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 November 2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Momelotinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0249/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0234/2019
08/11/2019 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated, adjuvanted) : List of nationally authorised medicinal products - PSUSA/00010300/201903
08/11/2019 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/201903
08/11/2019 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated, prepared in cell cultures) : List of nationally authorised medicinal products - PSUSA/00010299/201903
08/11/2019 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/201903
08/11/2019 Human medicines European public assessment report (EPAR): Trulicity, dulaglutide, Diabetes Mellitus, Type 2, 21/11/2014, Additional monitoring, 11, Authorised
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype) / Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype) / Recombinant Influenza Hemagglutinin-strain B (Victoria lineage) / Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4), PM: decision on the application for modification of an agreed PIP, P/0219/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab, PM: decision on the application for modification of an agreed PIP, P/0206/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, palbociclib, PM: decision on the application for modification of an agreed PIP, P/0203/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (JCAR017, lisocabtagene maraleucel), PM: decision on the application for modification of an agreed PIP, P/0198/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): ravulizumab, PM: decision on the application for modification of an agreed PIP, P/0199/2019
08/11/2019 Human medicines European public assessment report (EPAR): Xospata, gilteritinib fumarate, Leukemia, Myeloid, Acute, 24/10/2019, Orphan, Additional monitoring, Authorised
08/11/2019 Orphan designation: Gilteritinib for the: Treatment of acute myeloid leukaemia, 17/01/2018, Positive
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tecentriq, atezolizumab, PM: decision on the application for modification of an agreed PIP, P/0207/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humanised anti-IL-6 receptor (IL-6R) monoclonal antibody, PM: decision on the application for modification of an agreed PIP, P/0220/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, PM: decision on the application for modification of an agreed PIP, P/0197/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib, PM: decision on the application for modification of an agreed PIP, P/0201/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid, PM: decision on the application for modification of an agreed PIP, P/0204/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Terbinafine hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0221/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Lenvatinib, PM: decision on the application for modification of an agreed PIP, P/0209/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Noxafil, posaconazole, PM: decision on the application for modification of an agreed PIP, P/0223/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel, PM: decision on the application for modification of an agreed PIP, P/0217/2019
08/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Edurant, Rilpivirine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0205/2019
07/11/2019 Agenda: Agenda - CAT agenda of the 6-8 November 2019 meeting
07/11/2019 Human medicines European public assessment report (EPAR): PecFent, fentanyl, Pain, Cancer, 31/08/2010, 19, Authorised
07/11/2019 Human medicines European public assessment report (EPAR): Telmisartan Teva Pharma, telmisartan, Hypertension, 03/10/2011, Generic, 8, Authorised
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): capivasertib, W: decision granting a waiver in all age groups for all conditions or indications, P/0214/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): sutimlimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0211/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): emiplacel, W: decision granting a waiver in all age groups for all conditions or indications, P/0200/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ramipril,bisoprolol, W: decision granting a waiver in all age groups for all conditions or indications, P/0212/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): tisotumab vedotin, W: decision granting a waiver in all age groups for all conditions or indications, P/0216/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): 2-(2-(3-Butoxy-phenyl)-ethylamino)-N,N-dimethyl-acetamide hydrochloride, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0215/2019
07/11/2019 Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Angina Pectoris, Heart Failure, 08/09/2015, 5, Authorised
07/11/2019 Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, 26/08/2010, Orphan, Accelerated assessment, 12, Authorised
07/11/2019 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 5 containing a B-domain deleted variant of human coagulation factor VIII gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0218/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Glu-NH-CO-NH-Lys-(Ahx)-[N,N9-bis[2-hydroxy-5-(carboxyethyl) benzyl]ethylenediamine-N,N9-diacetic acid (PSMA11-HBED-CC) (HBED Trasis), (EMEA-002503-PIP01-18), W: decision granting a waiver in all age groups for all conditions or indications, P/0208/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): dexamethasone, RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0210/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lentiviral vector containing the human ABCA4 gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0213/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, W: decision granting a waiver in all age groups for all conditions or indications, P/0202/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): tilsotolimod, W: decision granting a waiver in all age groups for all conditions or indications, P/0222/2019
07/11/2019 Periodic safety update single assessment: Enoxaparin (except for biosimilars) : List of nationally authorised medicinal products - PSUSA/00010560/201904
07/11/2019 Newsletter: Human medicines highlights - November 2019
07/11/2019 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
07/11/2019 Medicines under additional monitoring: Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Isatuximab, PM: decision on the application for modification of an agreed PIP, P/0193/2019
07/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fc- and CDR-modified humanised monoclonal antibody against C5 (ravulizumab), PM: decision on the application for modification of an agreed PIP, P/0166/2019
07/11/2019 Human medicines European public assessment report (EPAR): Victoza, liraglutide, Diabetes Mellitus, Type 2, 30/06/2009, 20, Authorised
06/11/2019 Human medicines European public assessment report (EPAR): Brintellix, Vortioxetine, Depressive Disorder, Major, 18/12/2013, 13, Authorised
06/11/2019 Human medicines European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals), split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human, Immunization, Disease Outbreaks, 10/10/2009, Exceptional circumstances, 10, Authorised
06/11/2019 Agenda: Meeting summary - EMA, Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA)
06/11/2019 Tripartite meeting held between the EMA, Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) to discuss regulatory approaches for the evaluation of antibacterial agents , Tokyo, Japan, from 24/09/2019 to 25/09/2019
06/11/2019 EPAR - Procedural steps taken and scientific information after authorisation: Olazax : EPAR - Procedural steps taken and scientific information after authorisation
06/11/2019 Human medicines European public assessment report (EPAR): Olazax, olanzapine, Schizophrenia, Bipolar Disorder, 11/12/2009, Generic, 11, Authorised
06/11/2019 Other: List of eligible industry stakeholder organisations
06/11/2019 Report: Applications for new human medicines under evaluation by the CHMP: November 2019
06/11/2019 Minutes: Minutes of CHMP written procedure 19-22 August 2019
06/11/2019 Human medicines European public assessment report (EPAR): Temozolomide Accord, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 18, Authorised
05/11/2019 Human medicines European public assessment report (EPAR): Axura, memantine hydrochloride, Alzheimer Disease, 17/05/2002, 25, Authorised
05/11/2019 Human medicines European public assessment report (EPAR): Memantine Merz, memantine hydrochloride, Alzheimer Disease, 22/11/2012, 6, Authorised
05/11/2019 Periodic safety update single assessment: Nicorandil : List of nationally authorised medicinal products - PSUSA-00002152-201902
05/11/2019 Agenda: Agenda - CVMP agenda of the 5-7 November 2019 meeting
05/11/2019 Other: CHMP meeting dates 2019, 2020 and 2021
05/11/2019 Periodic safety update single assessment: Allergen for therapy: Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010693/201904
05/11/2019 Human medicines European public assessment report (EPAR): Blincyto, blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 23/11/2015, Orphan, Additional monitoring, 10, Authorised
04/11/2019 Agenda: Agenda - COMP agenda of the 05-07 November 2019 meeting
04/11/2019 Periodic safety update single assessment: Alprazolam : List of nationally authorised medicinal products - PSUSA/00000109/201903
04/11/2019 Agenda: Agenda - Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features
04/11/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: August-September 2019
04/11/2019 eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Lyon) , Lyon, France, from 05/12/2019 to 06/12/2019
04/11/2019 Agenda: Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Lyon)
04/11/2019 ISO/ICH E2B(R3) Individual case safety reporting in the EU: Hands-on training course using the EudraVigilance system , Lyon, France, from 02/12/2019 to 04/12/2019
04/11/2019 Other: Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of substance information
04/11/2019 Regulatory and procedural guideline: EudraVigilance release notes v.1.22
04/11/2019 Human medicines European public assessment report (EPAR): Bavencio, avelumab, Neuroendocrine Tumors, 18/09/2017, Additional monitoring, Conditional approval, 5, Authorised
04/11/2019 European Medicines Agency (EMA) Patients' and Consumers' Working Party meeting (PCWP) , European Medicines Agency, Amsterdam, the Netherlands, from 24/09/2019 to 24/09/2019
04/11/2019 European Medicines Agency (EMA) Healthcare Professionals' Working Party (HCPWP) meeting , European Medicines Agency, Amsterdam, the Netherlands, from 24/09/2019 to 24/09/2019
04/11/2019 European Medicines Agency (EMA) Joint Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) meeting , European Medicines Agency, Amsterdam, the Netherlands, from 25/09/2019 to 25/09/2019
  •