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, , 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, , 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, , 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, , 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, , 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, , 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, , 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, , 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, , 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, , , 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, , , 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, , 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, , , 5, Authorised (updated) |
14/01/2021 |
Human medicines European public assessment report (EPAR): Mayzent, Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting, 13/01/2020, , 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, , , , 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, , 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, , 10, Authorised (updated) |
13/01/2021 |
Human medicines European public assessment report (EPAR): Phesgo, pertuzumab, trastuzumab, Breast Neoplasms, 21/12/2020, , 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, , , 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, , 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, , 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, , 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, , , 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, , 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, , , 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, , , , 8, Authorised (updated) |
07/01/2021 |
Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Multiple Myeloma, 18/12/2020, , 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, , 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, , , 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, , , 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, , , 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, , 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, , Authorised |
05/01/2021 |
Human medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa, 22/11/2018, , , 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, , 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, , , 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, , 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, , 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, , Authorised |
04/01/2021 |
Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 15/11/2017, , , 7, Authorised (updated) |
04/01/2021 |
Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Psoriasis, 25/04/2016, , 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, , 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, , , 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) |