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Date Content
19/01/2021 Veterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, 11/02/2014, 13, Authorised (updated)
19/01/2021 Periodic safety update single assessment: Gadopentetic acid: List of nationally authorised medicinal products - PSUSA/00001504/202004 (new)
19/01/2021 Periodic safety update single assessment: Mifepristone / misoprostol: List of nationally authorised medicinal products - PSUSA/00010378/202005 (new)
19/01/2021 Human medicines European public assessment report (EPAR): Recarbrio, imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections, 13/02/2020, Additional monitoring, 1, Authorised (updated)
19/01/2021 Human medicines European public assessment report (EPAR): Ryzodeg, insulin aspart, insulin degludec, Diabetes Mellitus, 21/01/2013, 12, Authorised (updated)
19/01/2021 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
19/01/2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 1 , Virtual event, from 22/02/2021 to 22/02/2021
19/01/2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 2 , Virtual event, from 04/03/2021 to 04/03/2021
19/01/2021 Periodic safety update single assessment: Amfepramone: List of nationally authorised medicinal products - PSUSA/00000138/202006 (new)
19/01/2021 Newsletter: News bulletin for small and medium-sized enterprises - Issue 51 (new)
19/01/2021 Human medicines European public assessment report (EPAR): Roteas, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/04/2017, Additional monitoring, 8, Authorised (updated)
19/01/2021 Agenda: Agenda - CAT agenda of the 20-22 January 2021 meeting (new)
19/01/2021 Agenda: Agenda - CVMP agenda of the 19-21 January 2021 meeting (new)
19/01/2021 News and press releases: Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines
19/01/2021 International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
19/01/2021 COVID-19: latest updates (updated)
19/01/2021 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, Patient safety, 32, Authorised (updated)
19/01/2021 Eligible patients and consumers organisations (updated)
18/01/2021 Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Gaucher Disease, 17/11/1997, 25, Authorised (updated)
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 (updated)
18/01/2021 Human medicines European public assessment report (EPAR): Incruse Ellipta (previously Incruse), umeclidinium bromide, Pulmonary Disease, Chronic Obstructive, 28/04/2014, Additional monitoring, 14, Authorised (updated)
18/01/2021 Periodic safety update single assessment: Simvastatin: List of nationally authorised medicinal products - PSUSA/00002709/202004 (new)
18/01/2021 Human medicines European public assessment report (EPAR): Yervoy, Ipilimumab, Melanoma, 12/07/2011, 35, Authorised (updated)
18/01/2021 Agenda: Agenda - COMP agenda of the 19-21 January 2021 meeting (new)
18/01/2021 Withdrawn application: Puldysa, idebenone, Date of withdrawal: 28/10/2020, Initial authorisation (updated)
18/01/2021 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: November 2020 (new)
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 (updated)
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 (updated)
18/01/2021 Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 12, Authorised (updated)
18/01/2021 Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Clostridium Infections, 05/12/2011, 13, Authorised (updated)
18/01/2021 Other: Organisation chart: Information Management (updated)
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 (new)
18/01/2021 Periodic safety update single assessment: Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025 (new)
18/01/2021 Periodic safety update single assessment: Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005 (new)
18/01/2021 Periodic safety update single assessment: Ivabradine / metoprolol : List of nationally authorised medicinal products - PSUSA/00010381/202004 (new)
18/01/2021 Periodic safety update single assessment: Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (new)
18/01/2021 Periodic safety update single assessment: Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (new)
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 (updated)
18/01/2021 Periodic safety update single assessment: Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/202004 (new)
18/01/2021 Human medicines European public assessment report (EPAR): Bortezomib Fresenius Kabi, bortezomib, Multiple Myeloma, 14/11/2019, Generic, 3, Authorised (updated)
18/01/2021 Periodic safety update single assessment: Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004 (new)
15/01/2021 Other: CHMP meeting dates 2019, 2020 and 2021 (updated)
15/01/2021 Human medicines European public assessment report (EPAR): Tyverb, lapatinib, Breast Neoplasms, 10/06/2008, 31, Authorised (updated)
15/01/2021 Transparency: exceptional measures for COVID-19 medicines (updated)
15/01/2021 Periodic safety update single assessment: Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005 (new)
15/01/2021 Committee meeting report: COMP meeting report on the review of applications for orphan designation: September 2020 (updated)
15/01/2021 Scientific publications (updated)
15/01/2021 Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 31, Authorised (updated)
15/01/2021 Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Diabetes Mellitus, 20/01/2013, 14, Authorised (updated)
15/01/2021 News and press releases: Cyberattack on EMA - update 5 (updated)
15/01/2021 Agenda: Agenda - HMPC agenda of the 11-13 January 2021 meeting (new)
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 (updated)
15/01/2021 Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi, busulfan, Hematopoietic Stem Cell Transplantation, 22/09/2014, Generic, 8, Authorised (updated)
15/01/2021 Human medicines European public assessment report (EPAR): INOmax, Nitric oxide, Hypertension, Pulmonary, Respiratory Insufficiency, 01/08/2001, 22, Authorised (updated)
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 (updated)
15/01/2021 Minutes: Minutes of the CHMP meeting 14-17 September 2020 (updated)
15/01/2021 Orphan designation: dimethyl fumarate for the: Adjunctive treatment in haematopoietic cell transplantation, 21/03/2018, Positive (updated)
15/01/2021 Human medicines European public assessment report (EPAR): Lenvima, lenvatinib mesilate, Thyroid Neoplasms, 28/05/2015, Accelerated assessment, Additional monitoring, 14, Authorised (updated)
15/01/2021 Other: Questions and answers on signal management (updated)
15/01/2021 Template or form: Application / re-evaluation form for the involvement of healthcare professionals’ organisations in the activities of the European Medicines Agency (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Sebivo, telbivudine, Hepatitis B, Chronic, 24/04/2007, 20, Withdrawn (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia, Cancer, 22/08/2002, 35, Authorised (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Nexium Control, esomeprazole, Gastroesophageal Reflux, 26/08/2013, 14, Authorised (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Accelerated assessment, Additional monitoring, 12, Authorised (updated)
14/01/2021 Referral: Ulipristal acetate 5mg medicinal products , Ulipristal acetate , Article 31 referrals, European Commission final decision, 12/11/2020, 11/01/2021, 14/01/2021 (updated)
14/01/2021 Coronavirus disease (COVID-19) (updated)
14/01/2021 Treatments and vaccines for COVID-19 (updated)
14/01/2021 National competent authorities (human) (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Zonisamide Mylan, zonisamide, Epilepsy, 31/03/2016, Generic, 5, Authorised (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Zonegran, zonisamide, Epilepsies, Partial, 10/03/2005, 32, Authorised (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 11/05/1998, 40, Authorised (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia, 03/12/1998, 38, Authorised (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/06/2015, 13, Authorised (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Rubraca, rucaparib camsylate, Ovarian Neoplasms, 23/05/2018, Additional monitoring, Conditional approval, 5, Authorised (updated)
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 (updated)
14/01/2021 Veterinary medicines European public assessment report (EPAR): Osurnia, betamethasone acetate, terbinafine, florfenicol, 31/07/2014, 10, Authorised (updated)
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 (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Valdoxan, Agomelatine, Depressive Disorder, Major, 19/02/2009, 22, Authorised (updated)
14/01/2021 Human medicines European public assessment report (EPAR): Thymanax, Agomelatine, Depressive Disorder, Major, 19/02/2009, 18/11/2006, 22, Authorised (updated)
14/01/2021 Medicines for use outside the European Union (updated)
14/01/2021 Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union (updated)
14/01/2021 Leaflet: EU-M4all - Promoting parallel application for EU-M4all opinion and centralised marketing authorisation procedure (new)
14/01/2021 Regulatory and procedural guideline: Guidance - Parallel application for EU-M4all (Article 58) opinion and centralised marketing authorisation procedure (new)
14/01/2021 EPAR - All authorised presentations: Sebivo : EPAR - All Authorised presentations (updated)
14/01/2021 EPAR - Scientific Discussion: Sebivo : EPAR - Scientific Discussion (updated)
14/01/2021 EPAR - Procedural steps taken before authorisation: Sebivo : EPAR - Procedural steps taken before authorisation (updated)
13/01/2021 Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 23/09/2009, Generic, 15, Authorised (updated)
13/01/2021 Human medicines European public assessment report (EPAR): Hexyon, diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 23, Authorised (updated)
13/01/2021 Human medicines European public assessment report (EPAR): Foclivia, influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks, 18/10/2009, Exceptional circumstances, 10, Authorised (updated)
13/01/2021 Human medicines European public assessment report (EPAR): Phesgo, pertuzumab, trastuzumab, Breast Neoplasms, 21/12/2020, Additional monitoring, Authorised
13/01/2021 Human medicines European public assessment report (EPAR): Fycompa, perampanel, Epilepsies, Partial, 23/07/2012, 19, Authorised (updated)
13/01/2021 Human medicines European public assessment report (EPAR): Stelara, Ustekinumab, Psoriasis, Arthritis, Psoriatic, Crohn Disease, 15/01/2009, 33, Authorised (updated)
13/01/2021 Eligible healthcare professionals' organisations (updated)
13/01/2021 Healthcare Professionals' Working Party (updated)
13/01/2021 Other: Decision of the Executive Director on rules governing the secondment of national experts to the EMA (updated)
13/01/2021 Agenda: Agenda - European Medicines Agency and European Healthcare Distribution Association (GIRP) bilateral meeting (new)
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 Dose review and adjustment of established veterinary antibiotics in the context summary of product characteristic (SPC) harmonisation (updated)
13/01/2021 Scientific guideline: Reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC harmonisation - First version (new)
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" (new)
13/01/2021 Report: Highlight report - Fifth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines (new)
13/01/2021 Newsletter: Human medicines highlights - January 2021 (new)
13/01/2021 Pre-authorisation guidance (updated)
13/01/2021 Generic and hybrid applications (updated)
13/01/2021 Risk management plan (RMP): questions and answers (updated)
13/01/2021 Post-authorisation efficacy studies: questions and answers (updated)
13/01/2021 Extensions of marketing authorisations: questions and answers (updated)
13/01/2021 Type-II variations: questions and answers (updated)
13/01/2021 Risk management (updated)
13/01/2021 Template or form: Marketing status reporting (updated)
13/01/2021 Template or form: Template to be used to notify the European Medcines Agency and concerned Member States of 'withdrawn products' (updated)
13/01/2021 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
13/01/2021 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
13/01/2021 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
13/01/2021 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
13/01/2021 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
13/01/2021 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
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 (updated)
12/01/2021 Regulatory and procedural guideline: Member states contact points for translations review (updated)
12/01/2021 EudraVigilance access policy for medicines for veterinary use (updated)
12/01/2021 Regulatory and procedural guideline: EudraVigilance access policy for medicines for veterinary use - Revision 2 (new)
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 (updated)
12/01/2021 Human medicines European public assessment report (EPAR): Amyvid, florbetapir (18F), Radionuclide Imaging, 14/01/2013, 13, Authorised (updated)
12/01/2021 Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Psoriasis, Arthritis, Rheumatoid, 02/02/2000, 63, Authorised (updated)
12/01/2021 Human medicines European public assessment report (EPAR): Comirnaty, Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection, 21/12/2020, Additional monitoring, Conditional approval, 1, Authorised (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
11/01/2021 Human medicines European public assessment report (EPAR): Ocrevus, ocrelizumab, Multiple Sclerosis, 08/01/2018, Additional monitoring, 8, Authorised (updated)
11/01/2021 Veterinary medicines European public assessment report (EPAR): Sileo, dexmedetomidine hydrochloride, 10/06/2015, 8, Authorised (updated)
11/01/2021 Agenda: Agenda - PRAC draft agenda of meeting 11-14 January 2021 (new)
11/01/2021 Other: Records of data processing activity relating to Slido’s audience interaction tool (public) (new)
11/01/2021 Human medicines European public assessment report (EPAR): Axumin, Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging, 21/05/2017, Additional monitoring, 10, Authorised (updated)
11/01/2021 Human medicines European public assessment report (EPAR): Panretin, alitretinoin, Sarcoma, Kaposi, 11/10/2000, 17, Withdrawn (updated)
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 (new)
11/01/2021 Periodic safety update single assessment: Flucloxacillin: List of nationally authorised medicinal products - PSUSA/00001402/202003 (new)
11/01/2021 Orphan designation: Tetrahydrobiopterin for the: Treatment of hyperphenylalaninaemia, 08/06/2004, Withdrawn (updated)
11/01/2021 Report: Applications for new human medicines under evaluation by the CHMP: January 2021 (new)
11/01/2021 Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Diabetes Mellitus, 08/02/2018, Additional monitoring, 4, Authorised (updated)
11/01/2021 Human medicines European public assessment report (EPAR): Orfadin, nitisinone, Tyrosinemias, 20/02/2005, 19, Authorised (updated)
11/01/2021 Human medicines European public assessment report (EPAR): BeneFIX, Nonacog alfa, Hemophilia B, 27/08/1997, 40, Authorised (updated)
08/01/2021 Other: European Medicines Agency’s privacy statement for the use of audience interaction tool Slido (new)
08/01/2021 Minutes: Minutes of the PRAC meeting 26-29 October 2020 (new)
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 (updated)
08/01/2021 Human medicines European public assessment report (EPAR): Daurismo, Glasdegib maleate, Leukemia, Myeloid, Acute, 26/06/2020, Orphan, Additional monitoring, 1, Authorised (updated)
08/01/2021 Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial, 22/03/2017, Generic, 9, Authorised (updated)
08/01/2021 Periodic safety update single assessment: Ethosuximide: List of nationally authorised medicinal products - PSUSA/00001316/202003 (new)
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 (new)
08/01/2021 Other: Comirnaty - Product Information as approved by the CHMP on 8 January 2021, pending endorsement by the European Commission (new)
08/01/2021 News and press releases: Extra dose from vials of Comirnaty COVID-19 vaccine
08/01/2021 Treatments and vaccines for COVID-19: research and development (updated)
08/01/2021 Treatments and vaccines for COVID-19: medicines under evaluation (updated)
08/01/2021 Treatments and vaccines for COVID-19: authorised medicines (updated)
08/01/2021 Treatments and vaccines for COVID-19: post-authorisation (updated)
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 (updated)
08/01/2021 Human medicines European public assessment report (EPAR): Xyrem, sodium oxybate, Cataplexy, Narcolepsy, 13/10/2005, 31, Authorised (updated)
08/01/2021 Human medicines European public assessment report (EPAR): Ninlaro, ixazomib citrate, Multiple Myeloma, 21/11/2016, Orphan, Additional monitoring, Conditional approval, 8, Authorised (updated)
07/01/2021 Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Multiple Myeloma, 18/12/2020, Generic, Authorised
07/01/2021 Human medicines European public assessment report (EPAR): Somavert, Pegvisomant, Acromegaly, 12/11/2002, 24, Authorised (updated)
07/01/2021 Veterinary medicines European public assessment report (EPAR): Rabitec, attenuated live rabies vaccine virus, strain SPBN GASGAS, 01/12/2017, 3, Authorised (updated)
07/01/2021 Minutes: Minutes of the CVMP meeting of 3-5 November 2020 (new)
07/01/2021 Minutes: Minutes of the CHMP meeting 9-12 November 2020 (new)
07/01/2021 Agenda: Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course (2021) (updated)
07/01/2021 Veterinary medicines European public assessment report (EPAR): Meloxidolor, meloxicam, 22/04/2013, Generic, 8, Authorised (updated)
07/01/2021 Human medicines European public assessment report (EPAR): Blitzima, rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 13/07/2017, Additional monitoring, Biosimilar, 9, Authorised (updated)
07/01/2021 Human medicines European public assessment report (EPAR): Rapamune, Sirolimus, Graft Rejection, Kidney Transplantation, 13/03/2001, 40, Authorised (updated)
07/01/2021 Human medicines European public assessment report (EPAR): Livogiva, teriparatide, Osteoporosis, 27/08/2020, Additional monitoring, Biosimilar, 1, Authorised (updated)
07/01/2021 Human medicines European public assessment report (EPAR): Rebif, interferon beta-1a, Multiple Sclerosis, 03/05/1998, 39, Authorised (updated)
07/01/2021 Orphan designation: adeno-associated viral vector serotype 2 containing the human REP1 gene (timrepigene emparvovec) for the: Treatment of spinal muscular atrophy, 24/08/2018, Withdrawn (updated)
07/01/2021 Human medicines European public assessment report (EPAR): Zirabev, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 14/02/2019, Additional monitoring, Biosimilar, 7, Authorised (updated)
06/01/2021 Summary of opinion: COVID-19 Vaccine Moderna, COVID-19 mRNA Vaccine (nucleoside modified), 06/01/2021, Positive
06/01/2021 EPAR - Risk-management-plan summary: COVID-19 Vaccine Moderna - Risk-management-plan (new)
06/01/2021 Human medicines European public assessment report (EPAR): Gliolan, 5-aminolevulinic acid hydrochloride, Glioma, 07/09/2007, 5, Authorised (updated)
06/01/2021 Human medicines European public assessment report (EPAR): Xoterna Breezhaler, indacaterol, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 18/09/2013, 15, Authorised (updated)
06/01/2021 COVID-19 vaccines: key facts (updated)
06/01/2021 News and press releases: EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU (updated)
06/01/2021 Veterinary medicines European public assessment report (EPAR): Bravecto Plus, fluralaner, moxidectin, 08/05/2018, 5, Authorised (updated)
06/01/2021 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC (new)
06/01/2021 Other: List of signals discussed at PRAC since September 2012 (updated)
06/01/2021 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC meeting (new)
06/01/2021 Human medicines European public assessment report (EPAR): Leqvio, inclisiran, Hypercholesterolemia, Dyslipidemias, 09/12/2020, Additional monitoring, Authorised
06/01/2021 Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
06/01/2021 Regulatory and procedural guideline: Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medi... (updated)
06/01/2021 Pharmacovigilance fees: questions and answers (updated)
06/01/2021 Other: Pharmacovigilance fees: questions and answers (updated)
06/01/2021 Minutes: Minutes of the CHMP meeting 12-15 October 2020 (new)
05/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0003/2021
05/01/2021 Minutes: Minutes of the COMP meeting 6-8 October 2020 (new)
05/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Allergen extracts of Dermatophagoides farinae and Dermatophagoides pteronyssinus (each 50%), PM: decision on the application for modification of an agreed PIP, P/0280/2015 (updated)
05/01/2021 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Pollen from Betula pendula - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (new)
05/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Anthoxhantum odoratum (16 %) and Secale cereale (20%), PM: decision on the application for modification of an agreed PIP, P/0279/2015 (updated)
05/01/2021 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Pollen from Dactylis glomarata(16%), Lolium perenne(16%), Phleum pratense(16%), Poa pratensis(16%), Anthoxhantum odoratum(16%), Secale cereale(20%) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (new)
05/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Betula pendula, PM: decision on the application for modification of an agreed PIP, P/0278/2015 (updated)
05/01/2021 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Allergen extracts of Dermatophagoides farinae and Dermatophagoides pteronyssinus (each 50%) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (new)
05/01/2021 Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Betula pendula (33%), Corylus avellana (33%) and Alnus glutinosa (33%), PM: decision on the application for modification of an agreed PIP, P/0277/2015 (updated)
05/01/2021 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Pollen from Betula pendula (33%), Corylus avellana (33%) and Alnus glutinosa (33%) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (new)
05/01/2021 Human medicines European public assessment report (EPAR): Trixeo Aerosphere, formoterol fumarate dihydrate, glycopyrronium bromide, budesonide, Pulmonary Disease, Chronic Obstructive, 09/12/2020, Authorised
05/01/2021 Human medicines European public assessment report (EPAR): Simulect, basiliximab, Graft Rejection, Kidney Transplantation, 09/10/1998, 25, Authorised (updated)
05/01/2021 Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 29/11/2009, 16, Authorised (updated)
05/01/2021 Human medicines European public assessment report (EPAR): Vocabria, Cabotegavir sodium, Cabotegravir, HIV Infections, 17/12/2020, Additional monitoring, Authorised
05/01/2021 Human medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa, 22/11/2018, Orphan, Additional monitoring, 3, Authorised (updated)
05/01/2021 Other: Nullification ICSRs received by EudraVigilance (updated)
05/01/2021 Referral: Ranitidine-containing medicinal products , ranitidine , Article 31 referrals, European Commission final decision, 17/09/2020, 24/11/2020, 05/01/2021 (updated)
05/01/2021 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC meeting (updated)
05/01/2021 Human medicines European public assessment report (EPAR): Telmisartan Actavis, telmisartan, Hypertension, 29/09/2010, Generic, 10, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Erelzi, etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing, 23/06/2017, Additional monitoring, Biosimilar, 8, Authorised (updated)
04/01/2021 Minutes: Minutes - PDCO minutes of the 1-4 September 2020 meeting (new)
04/01/2021 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Accelerated assessment, 16, Authorised (updated)
04/01/2021 Dapivirine Vaginal Ring 25 mg H-W-2168 (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Combivir, lamivudine, zidovudine, HIV Infections, 18/03/1998, 31, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Hexacima, hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 22, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Bondronat, ibandronic acid, Hypercalcemia, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, 25/06/1996, 30, Authorised (updated)
04/01/2021 Information Management (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Rinvoq, Upadacitinib, Arthritis, Rheumatoid, 16/12/2019, Additional monitoring, 2, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid, 08/09/2003, 80, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Rekambys, rilpivirine, HIV Infections, 17/12/2020, Additional monitoring, Authorised
04/01/2021 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 15/11/2017, Additional monitoring, Biosimilar, 7, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Psoriasis, 25/04/2016, Additional monitoring, 11, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate), clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke, 27/07/2009, Generic, 15, Authorised (updated)
04/01/2021 Direct healthcare professional communication (DHPC): Kaletra (lopinavir/ritonavir) oral solution, 2 bottle pack containing 2-ml oral dosing syringes: Presence of amide particles in 2-ml oral dosing syringes, Active substance: lopinavir, ritonavir, DHPC type: Quality defect, Last updated: 04/01/2021
04/01/2021 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 6, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders, Polycythemia Vera, 23/08/2012, 22, Authorised (updated)
04/01/2021 Human medicines European public assessment report (EPAR): Lonsurf, trifluridine, tipiracil hydrochloride, Colorectal Neoplasms, 25/04/2016, 6, Authorised (updated)