21/04/2021 |
News and press releases: Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation |
21/04/2021 |
Human medicines European public assessment report (EPAR): Giotrif, afatinib, Carcinoma, Non-Small-Cell Lung, 25/09/2013, 14, Authorised (updated) |
21/04/2021 |
COVID-19: latest updates (updated) |
21/04/2021 |
Human medicines European public assessment report (EPAR): COVID-19 Vaccine Janssen, adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection, 11/03/2021, , , 1, Authorised (updated) |
21/04/2021 |
Human medicines European public assessment report (EPAR): Piqray, Alpelisib, Breast Neoplasms, 27/07/2020, , 3, Authorised (updated) |
21/04/2021 |
Agenda: Agenda - PDCO agenda of the 20-23 April 2021 meeting
|
21/04/2021 |
Veterinary Big Data stakeholder forum
, Virtual event, from 01/06/2021 to 02/06/2021 (updated) |
21/04/2021 |
Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib (s)-malate, Carcinoma, Renal Cell, 09/09/2016, , , 10, Authorised (updated) |
21/04/2021 |
Template or form: Application form for European Medicines Agency certificates of medicinal products
(updated) |
21/04/2021 |
Periodic safety update single assessment: Gadoxetic acid disodium: List of nationally authorised medicinal products - PSUSA/00001509/202004
|
21/04/2021 |
Periodic safety update single assessment: Epirubicin: List of nationally authorised medicinal products - PSUSA/00001234/202006
|
21/04/2021 |
Periodic safety update single assessment: Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/202005
|
21/04/2021 |
Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia, 25/06/2020, , , 1, Authorised (updated) |
21/04/2021 |
Periodic safety update single assessment: Oxcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/202008
|
21/04/2021 |
Periodic safety update single assessment: Modafinil : List of nationally authorised medicinal products - PSUSA/00010242/202008
|
21/04/2021 |
Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Urologic Neoplasms, 19/06/2015, 36, Authorised (updated) |
21/04/2021 |
Human medicines European public assessment report (EPAR): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human, 12/12/2018, , 7, Authorised (updated) |
21/04/2021 |
Periodic safety update single assessment: Gadoteridol: List of nationally authorised medicinal products - PSUSA/00001507/202004
|
21/04/2021 |
Human medicines European public assessment report (EPAR): Samsca, Tolvaptan, Inappropriate ADH Syndrome, 02/08/2009, 14, Authorised (updated) |
21/04/2021 |
Periodic safety update single assessment: Gadobenic acid: List of nationally authorised medicinal products - PSUSA/00001500/202004
|
21/04/2021 |
Periodic safety update single assessment: Fluorescein (systemic use): List of nationally authorised medicinal products - PSUSA/00009153/202004
|
21/04/2021 |
Human medicines European public assessment report (EPAR): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 46, Authorised (updated) |
21/04/2021 |
Periodic safety update single assessment: Gadoteric acid (IV and intravascular formulations): List of nationally authorised medicinal products - PSUSA/00001506/202004
|
21/04/2021 |
Human medicines European public assessment report (EPAR): Herceptin, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 28/08/2000, 39, Authorised (updated) |
21/04/2021 |
Periodic safety update single assessment: Porfimer: List of nationally authorised medicinal products - PSUSA/00010332/202004
|
21/04/2021 |
Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus,Dermatophagoides farinae, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/146/2011 (updated) |
20/04/2021 |
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, , , 5, Authorised (updated) |
20/04/2021 |
Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Conscious Sedation, 26/03/2021, , Authorised |
20/04/2021 |
Report: Minutes - PDCO minutes of the 23-26 February 2021 meeting
|
20/04/2021 |
News and press releases: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets |
20/04/2021 |
Periodic safety update single assessment: Dalteparin sodium: List of nationally authorised medicinal products - PSUSA/00000922/202008
|
20/04/2021 |
Agenda: Agenda - Veterinary Big Data Stakeholder Forum
|
20/04/2021 |
Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes
(updated) |
20/04/2021 |
Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Multiple Sclerosis, 30/01/2014, 21, Authorised (updated) |
20/04/2021 |
Extraordinary Management Board meeting on CTIS audit
, European Medicines Agency, Amsterdam, the Netherlands, from 21/04/2021 to 21/04/2021 |
20/04/2021 |
Human medicines European public assessment report (EPAR): Vfend, voriconazole, Candidiasis, Mycoses, Aspergillosis, 19/03/2002, 48, Authorised (updated) |
20/04/2021 |
Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, , 14, Authorised (updated) |
20/04/2021 |
Human medicines European public assessment report (EPAR): Exforge, valsartan, amlodipine (as amlodipine besilate), Hypertension, 16/01/2007, 27, Authorised (updated) |
20/04/2021 |
Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021
, Virtual meeting, from 20/04/2021 to 20/04/2021 |
20/04/2021 |
Veterinary medicines European public assessment report (EPAR): NexGard Combo, eprinomectin, esafoxolaner, praziquantel, 06/01/2021, Authorised |
20/04/2021 |
Human medicines European public assessment report (EPAR): Vipidia, alogliptin, Diabetes Mellitus, Type 2, 18/09/2013, 6, Authorised (updated) |
19/04/2021 |
Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Muscular Atrophy, Spinal, 18/05/2020, , , , 2, Authorised (updated) |
19/04/2021 |
Newsletter: News bulletin for small and medium-sized enterprises - Issue 52
|
19/04/2021 |
Renewal and annual re-assessment of marketing authorisation (updated) |
19/04/2021 |
Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib mesilate, Melanoma, 26/08/2013, 24, Authorised (updated) |
19/04/2021 |
Human medicines European public assessment report (EPAR): Lonquex, lipegfilgrastim, Neutropenia, 25/07/2013, 20, Authorised (updated) |
19/04/2021 |
Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 21, Authorised (updated) |
19/04/2021 |
Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia, 03/12/1998, 39, Authorised (updated) |
19/04/2021 |
Periodic safety update single assessment: Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00001307/202007
|
19/04/2021 |
Human medicines European public assessment report (EPAR): Equidacent, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, 24/09/2020, , , 2, Authorised (updated) |
19/04/2021 |
Periodic safety update single assessment: Hexoprenaline sulfate: List of nationally authorised medicinal products - PSUSA/00003170/202008
|
19/04/2021 |
Other: Stakeholder engagement highlights 2020
|
19/04/2021 |
Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits : Imidacloprid
|
19/04/2021 |
Maximum Residue Limits - Report: Imidacloprid (fin fish): Summary report - Committee for Veterinary Medicinal Products
|
19/04/2021 |
Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, , 8, Authorised (updated) |
19/04/2021 |
Scientific recommendations on classification of advanced therapy medicinal products (updated) |
19/04/2021 |
Other: Scientific recommendations on classification of advanced therapy medicinal products
|
19/04/2021 |
Human medicines European public assessment report (EPAR): MenQuadfi, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 18/11/2020, , 1, Authorised (updated) |
19/04/2021 |
Other: Timetable: Informed consent and multiple application
(updated) |
19/04/2021 |
Report: Medicinal products for human use: monthly figures - March 2021
|
19/04/2021 |
Agenda: Agenda - CHMP agenda of the 19-22 April 2021 meeting
|
16/04/2021 |
Human medicines European public assessment report (EPAR): Onglyza, Saxagliptin, Diabetes Mellitus, Type 2, 30/09/2009, 19, Authorised (updated) |
16/04/2021 |
Human medicines European public assessment report (EPAR): Jinarc, Tolvaptan, Polycystic Kidney, Autosomal Dominant, 27/05/2015, , 15, Authorised (updated) |
16/04/2021 |
Press briefing on PRAC conclusions on signal of thromboembolic events with COVID-19 Vaccine Janssen
, Virtual meeting, from 20/04/2021 to 20/04/2021 |
16/04/2021 |
Veterinary medicines European public assessment report (EPAR): Prevexxion RN, Live recombinant Marek’s disease (MD) virus, serotype 1, strain RN1250, 20/07/2020, Authorised |
16/04/2021 |
Supply shortage: Shortage of Vfend (voriconazole) supply shortage
|
16/04/2021 |
Human medicines European public assessment report (EPAR): Kesimpta, ofatumumab, Multiple Sclerosis, Relapsing-Remitting, 26/03/2021, , Authorised |
16/04/2021 |
EPAR - Product Information: Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Product information
(updated) |
16/04/2021 |
Withdrawn application: Tibsovo, ivosidenib, Date of withdrawal: 13/10/2020, Initial authorisation (updated) |
16/04/2021 |
News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021 |
16/04/2021 |
Overview of comments: Allergen for therapy: Dermatophagoides pteronyssinus / Dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure): List of nationally authorised medicinal products - PSUSA/00010582/202009
|
16/04/2021 |
Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 24, Authorised (updated) |
16/04/2021 |
Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), ChAdOx1-SARS-COV-2, COVID-19 virus infection, 29/01/2021, , , 5, Authorised (updated) |
16/04/2021 |
Pre-authorisation guidance (updated) |
16/04/2021 |
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
(updated) |
16/04/2021 |
Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
(updated) |
16/04/2021 |
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes
(updated) |
16/04/2021 |
Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
(updated) |
16/04/2021 |
Changing the labelling and package leaflet (Article 61(3) notifications) (updated) |
16/04/2021 |
Transfer of marketing authorisation: questions and answers (updated) |
16/04/2021 |
Periodic safety update reports (PSURs) (updated) |
16/04/2021 |
Post-authorisation measures: questions and answers (updated) |
16/04/2021 |
COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 April 2021
|
16/04/2021 |
COVID-19 vaccines: authorised (updated) |
16/04/2021 |
COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 14 April 2021
|
16/04/2021 |
Herbal medicinal product: Hyperici herba, Hyperici herba, P: Draft published
(updated) |
16/04/2021 |
Grouping of variations: questions and answers (updated) |
16/04/2021 |
Worksharing: questions and answers (updated) |
16/04/2021 |
Extensions of marketing authorisations: questions and answers (updated) |
16/04/2021 |
Type-II variations: questions and answers (updated) |
16/04/2021 |
Type-IA variations: questions and answers (updated) |
16/04/2021 |
Type-IB variations: questions and answers (updated) |
16/04/2021 |
Post-authorisation safety studies (PASS) (updated) |
16/04/2021 |
COVID-19 vaccine safety update: COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 April 2021
|
16/04/2021 |
Herbal – European Union herbal monograph: Draft European Union herbal monograph on Trigonella foenum-graecum L., semen - Revision 1
|
16/04/2021 |
Herbal - HMPC assessment report: Draft Assessment report on Trigonella foenum-graecum L., semen - Revision 1
|
16/04/2021 |
Herbal medicinal product: Trigonellae foenugraeci semen, Trigonellae foenugraeci semen, F: Assessment finalised
(updated) |
15/04/2021 |
Veterinary medicines European public assessment report (EPAR): Prevexxion RN+HVT+IBD, Live recombinant Marek’s disease virus, serotype 1, strain RN1250; Live recombinant turkey herpesvirus, expressing the VP2 protein of infectious bursal disease virus, strain vHVT013-69, 20/07/2020, Authorised |
15/04/2021 |
Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 16, Authorised (updated) |
15/04/2021 |
Regulatory and procedural guideline: IRIS guide to registration
(updated) |
15/04/2021 |
Periodic safety update single assessment: Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/202008
|
15/04/2021 |
COVID-19 vaccines: Article 5(3) reviews (updated) |
15/04/2021 |
Human medicines European public assessment report (EPAR): Zometa, zoledronic acid, zoledronic acid monohydrate, Cancer, Fractures, Bone, 20/03/2001, 35, Authorised (updated) |
15/04/2021 |
Periodic safety update single assessment: Ethinylestradiol / etonogestrel: List of nationally authorised medicinal products - PSUSA/00001307/202007
|
15/04/2021 |
Periodic safety update single assessment: Ethinylestradiol / etonogestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001307/202007
|
15/04/2021 |
Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 22, Authorised (updated) |
15/04/2021 |
Human medicines European public assessment report (EPAR): Oyavas, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 26/03/2021, , , Authorised |
15/04/2021 |
Orphan designation: Somapacitan
for the: Treatment of growth hormone deficiency, 24/08/2018, Positive (updated) |
15/04/2021 |
Human medicines European public assessment report (EPAR): Sogroya, Somapacitan, Growth, 31/03/2021, , Authorised |
15/04/2021 |
News and press releases: EMA starts review of VIR-7831 for treating patients with COVID-19 |
15/04/2021 |
Periodic safety update single assessment: Octreotide: List of nationally authorised medicinal products - PSUSA/00002201/202006
|
15/04/2021 |
Periodic safety update single assessment: Octreotide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002201/202006
|
15/04/2021 |
Joint HMA/EMA workshop on artificial intelligence in medicines regulation
, Virtual event, from 19/04/2021 to 20/04/2021 (updated) |
15/04/2021 |
Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, 17/03/2011, 19, Authorised (updated) |
15/04/2021 |
Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, , 13, Authorised (updated) |
15/04/2021 |
Direct healthcare professional communication (DHPC): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe, Active substance: aflibercept, DHPC type: Adverse event, Last updated: 15/04/2021 |
15/04/2021 |
Periodic safety update single assessment: Nifedipine: List of nationally authorised medicinal products - PSUSA/00002156/202008
|
15/04/2021 |
Report: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive
|
15/04/2021 |
Paediatric investigation plans (updated) |
15/04/2021 |
Other: Common Commentary - EMA/FDA: Common issues requested for discussion by the respective agency (EMA/PDCO and FDA) concerning paediatric oncology development plans (Paediatric Investigation Plans [PIPs] and initial Pediatric Study Plans [iPSPs])
|
14/04/2021 |
European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021
, Virtual meeting, from 25/03/2021 to 25/03/2021 (updated) |
14/04/2021 |
Human medicines European public assessment report (EPAR): Vazkepa, Icosapent ethyl, Dyslipidemias, 26/03/2021, Authorised |
14/04/2021 |
Agenda: Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course (2021)
(updated) |
14/04/2021 |
Human medicines European public assessment report (EPAR): Yondelis, trabectedin, Ovarian Neoplasms, Sarcoma, 17/09/2007, 26, Authorised (updated) |
14/04/2021 |
Referrals document: Letter from Commissioner Kyriakides asking EMA to follow up on Vaxzevria opinion after Council discussion
|
14/04/2021 |
News and press releases: AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets |
14/04/2021 |
COVID-19 vaccines (updated) |
14/04/2021 |
Article 5(3) opinions (updated) |
14/04/2021 |
Other: Article 57 product data
(updated) |
14/04/2021 |
Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 28, Authorised (updated) |
14/04/2021 |
Periodic safety update single assessment: Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/202008
|
14/04/2021 |
Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms, Stomach Neoplasms, 27/07/2020, , , 3, Authorised (updated) |
14/04/2021 |
Human medicines European public assessment report (EPAR): PecFent, fentanyl, Pain, Cancer, 31/08/2010, 20, Authorised (updated) |
14/04/2021 |
Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, , 9, Authorised (updated) |
14/04/2021 |
News and press releases: COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues |
14/04/2021 |
Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, , 5, Authorised (updated) |
14/04/2021 |
News and press releases: IT systems intermittently unavailable from 16 to 18 April 2021 |
14/04/2021 |
Veterinary medicines European public assessment report (EPAR): Enteroporc Coli, Inactivated fimbrial adhesins of Escherichia coli F4ab, Inactivated fimbrial adhesins of Escherichia coli F4ac, Inactivated fimbrial adhesins of Escherichia coli F5, Inactivated fimbrial adhesins of Escherichia coli F6, 06/01/2021, Authorised |
14/04/2021 |
Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2021
|
14/04/2021 |
Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
(updated) |
14/04/2021 |
Periodic safety update single assessment: Pefloxacin: List of nationally authorised medicinal products - PSUSA/00002322/202008
|
14/04/2021 |
Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 13/02/2020, , 1, Authorised (updated) |
14/04/2021 |
Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain, Cancer, 04/04/2008, 23, Authorised (updated) |
14/04/2021 |
Human medicines European public assessment report (EPAR): BroPair Spiromax, salmeterol xinafoate, fluticasone propionate, Asthma, 26/03/2021, Authorised |
14/04/2021 |
Overview of comments: Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’
|
14/04/2021 |
Agenda: Agenda - CAT agenda of the 14-16 April 2021 meeting
|
14/04/2021 |
Agenda: Programme and registration form - Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System
(updated) |
14/04/2021 |
Agenda: Agenda - Technical workshop on real-world metadata for regulatory purposes
(updated) |
14/04/2021 |
Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU
, Virtual meeting, 13:00 - 15:15 (CET), from 26/03/2021 to 26/03/2021 (updated) |
14/04/2021 |
Newsletter: Human medicines highlights - April 2021
|
13/04/2021 |
Human medicines European public assessment report (EPAR): Seffalair Spiromax, fluticasone propionate, salmeterol xinafoate, Asthma, 26/03/2021, Authorised |
13/04/2021 |
Human medicines European public assessment report (EPAR): Ontozry, cenobamate, Epilepsy, 26/03/2021, , Authorised |
13/04/2021 |
Human medicines European public assessment report (EPAR): Rukobia, fostemsavir trometamol, HIV Infections, 04/02/2021, , 1, Authorised (updated) |
13/04/2021 |
Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), Tobramycin, Respiratory Tract Infections, Cystic Fibrosis, 18/02/2019, 3, Authorised (updated) |
13/04/2021 |
Template or form: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based data collection form
(updated) |
13/04/2021 |
Other: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based sales and and animal population data collection protocol
(updated) |
13/04/2021 |
European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated) |
13/04/2021 |
PRAC recommendation on signal: Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant]) – Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (Other viral vaccines)
|
13/04/2021 |
Committee for Orphan Medicinal Products (COMP): 13-15 April 2021
, European Medicines Agency, Amsterdam, the Netherlands, from 13/04/2021 to 15/04/2021 (updated) |
13/04/2021 |
Agenda: Agenda - COMP agenda of the 13-15 April 2021 meeting
|
13/04/2021 |
Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia, Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021 |
13/04/2021 |
Agenda: Agenda - CVMP agenda of the 13-15 March 2021 meeting
|
13/04/2021 |
Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload, beta-Thalassemia, 26/09/2019, , 4, Authorised (updated) |
13/04/2021 |
Human medicines European public assessment report (EPAR): Beromun, tasonermin, Sarcoma, 12/04/1999, 14, Authorised (updated) |
13/04/2021 |
Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 42, Authorised (updated) |
12/04/2021 |
Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 21, Authorised (updated) |
12/04/2021 |
Work programme: Nitrosamine Implementation Oversight Group Terms of Reference
|
12/04/2021 |
Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
, from 31/03/2021 to 31/03/2021 (updated) |
12/04/2021 |
Nitrosamine Implementation Oversight Group (NIOG) - Kick-off meeting
, from 10/03/2021 to 10/03/2021 |
12/04/2021 |
Nitrosamine impurities (updated) |
12/04/2021 |
Orphan designation: Ribavirin
for the: Treatment of Lassa fever, 21/02/2018, Positive (updated) |
12/04/2021 |
Orphan designation: Ribavirin
for the: Treatment of Crimean-Congo haemorrhagic fever, 21/03/2018, Positive (updated) |
12/04/2021 |
Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, 14/01/2019, , 3, Authorised (updated) |
12/04/2021 |
Clinical Trials Information System (CTIS): training programme (updated) |
12/04/2021 |
Human medicines European public assessment report (EPAR): Ixiaro, Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese, Immunization, 31/03/2009, 17, Authorised (updated) |
12/04/2021 |
Veterinary medicines European public assessment report (EPAR): Leucofeligen FeLV/RCP, purified p45 feline leukaemia virus envelope antigen, live feline calicivirus (strain F9), live feline viral rhinotracheitis virus (strain F2), live feline panleucopenia virus, 24/06/2009, 8, Authorised (updated) |
09/04/2021 |
Compliance: Overview (updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, , 9, Authorised (updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Zoledronic acid Mylan, zoledronic acid, Fractures, Bone, 23/08/2012, , 11, Authorised (updated) |
09/04/2021 |
Orphan designation: Ixazomib
for the: Treatment of systemic light chain amyloidosis, 08/11/2012, Withdrawn (updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Jentadueto, linagliptin, metformin, Diabetes Mellitus, Type 2, 19/07/2012, 19, Authorised (updated) |
09/04/2021 |
Webinar on reporting suspected side effects following administration of veterinary medicines
, Virtual meeting, from 30/03/2021 to 30/03/2021 (updated) |
09/04/2021 |
Report: Hearing with the Association of the European Self-Medication Industry (AESGP) during the HMPC November 2020 meeting
|
09/04/2021 |
Interested Parties to the HMPC (updated) |
09/04/2021 |
Agenda: Programme and registration form - Risk management information day 2021
|
09/04/2021 |
Risk management information day 2021
, Virtual meeting, from 15/06/2021 to 15/06/2021 |
09/04/2021 |
Other: Nullification ICSRs received by EudraVigilance
(updated) |
09/04/2021 |
Technical workshop on real-world metadata for regulatory purposes
, Virtual meeting, from 12/04/2021 to 12/04/2021 (updated) |
09/04/2021 |
Other: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)
(updated) |
09/04/2021 |
News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021 |
09/04/2021 |
Human medicines European public assessment report (EPAR): Coagadex, Human coagulation factor X, Factor X Deficiency, 16/03/2016, , , , 7, Authorised (updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Opsumit, Macitentan, Hypertension, Pulmonary, 20/12/2013, , 17, Authorised (updated) |
09/04/2021 |
Orphan designation: Adeno-associated viral vector serotype 9 containing the human cardiac calsequestrin gene
for the: Treatment of catecholaminergic polymorphic ventricular tachycardia, 29/07/2014, Positive (updated) |
09/04/2021 |
Herbal medicinal product: Cinnamomi cortex, Cinnamomi cortex, F: Assessment finalised
(updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Trimbow, Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 17/07/2017, 5, Authorised (updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Dovprela (previously Pretomanid FGK), Pretomanid, Tuberculosis, Multidrug-Resistant, 31/07/2020, , , , 3, Authorised (updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 12/12/2018, , , 6, Authorised (updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, 13, Authorised (updated) |
09/04/2021 |
Orphan designation: Radio-iodinated (131I) anti-CD45 murine monoclonal antibody
for the: Treatment in haematopoietic stem cell transplantation, 14/10/2016, Positive (updated) |
09/04/2021 |
Human medicines European public assessment report (EPAR): Rubraca, rucaparib camsylate, Ovarian Neoplasms, 23/05/2018, , , 6, Authorised (updated) |
08/04/2021 |
Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia, Bipolar Disorder, 12/12/2007, , 28, Authorised (updated) |
08/04/2021 |
Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, 30/05/2017, , , , , 5, Authorised (updated) |
08/04/2021 |
Human medicines European public assessment report (EPAR): Xromi, hydroxycarbamide, Anemia, Sickle Cell, 01/07/2019, Authorised (updated) |
08/04/2021 |
Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 08/02/2018, , 6, Authorised (updated) |
08/04/2021 |
Plasma master file certificates (updated) |
08/04/2021 |
Orphan designation: Chimeric monoclonal antibody against claudin 6
for the: Treatment of ovarian cancer, 24/01/2013, Withdrawn (updated) |
08/04/2021 |
Human medicines European public assessment report (EPAR): Pegasys, peginterferon alfa-2a, Hepatitis C, Chronic, Hepatitis B, Chronic, 20/06/2002, 42, Authorised (updated) |
08/04/2021 |
Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy, Anxiety Disorders, Neuralgia, 05/07/2004, 49, Authorised (updated) |
08/04/2021 |
Human medicines European public assessment report (EPAR): Cubicin, daptomycin, Gram-Positive Bacterial Infections, Bacteremia, Soft Tissue Infections, Endocarditis, Bacterial, 19/01/2006, 35, Authorised (updated) |
08/04/2021 |
Veterinary medicines European public assessment report (EPAR): Syvazul BTV, Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004, Inactivated bluetongue virus, serotype 8, strain BEL2006/01, 09/01/2019, 2, Authorised (updated) |
08/04/2021 |
Other: HMPC: overview of assessment work - priority list
(updated) |
07/04/2021 |
Human medicines European public assessment report (EPAR): Doptelet, avatrombopag maleate, Thrombocytopenia, 20/06/2019, , 4, Authorised (updated) |
07/04/2021 |
Periodic safety update single assessment: Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/202007
|
07/04/2021 |
Periodic safety update single assessment: Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010390/202007
|
07/04/2021 |
Human medicines European public assessment report (EPAR): Kymriah, tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, 22/08/2018, , , 4, Authorised (updated) |
07/04/2021 |
Periodic safety update single assessment: Primidone: List of nationally authorised medicinal products - PSUSA/00002525/202006
|
07/04/2021 |
Periodic safety update single assessment: Primidone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002525/202006
|
07/04/2021 |
Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, , , 6, Authorised (updated) |
07/04/2021 |
News and press releases: AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets |
07/04/2021 |
Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, 14/01/2015, , 11, Authorised (updated) |
07/04/2021 |
Human medicines European public assessment report (EPAR): Vaxchora, vibrio cholerae, strain cvd 103-hgr, live, Cholera, 01/04/2020, , 2, Authorised (updated) |
07/04/2021 |
Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 30, Authorised (updated) |
07/04/2021 |
Orphan designation: Recombinant human glutamate oxaloacetate transaminase 1
for the: Treatment of glioma, 12/02/2015, Withdrawn (updated) |
07/04/2021 |
Human medicines European public assessment report (EPAR): Competact, pioglitazone, metformin hydrochloride, Diabetes Mellitus, Type 2, 28/07/2006, 19, Authorised (updated) |
07/04/2021 |
Other: Records of data processing activity for the handling the contribution towards commuting costs (public)
|
07/04/2021 |
Orphan designation: Allogeneic multi-virus specific T lymphocytes targeting BK virus, cytomegalovirus, human herpesvirus-6, Epstein Barr virus and adenovirus
for the: Treatment in haematopoietic stem cell transplantation, 24/03/2020, Positive (updated) |
07/04/2021 |
Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol, Mometasone furoate, Asthma, 30/05/2020, 1, Authorised (updated) |
07/04/2021 |
Change management for the EudraVigilance system (updated) |
07/04/2021 |
Regulatory and procedural guideline: European Union individual case safety report (ICSR) implementation guide
(updated) |
07/04/2021 |
Regulatory and procedural guideline: EU reference instances (EDQM revision)
|
07/04/2021 |
Regulatory and procedural guideline: EU E2B (R3) testing files (EDQM revision)
|
07/04/2021 |
Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, , , 13, Authorised (updated) |
07/04/2021 |
Press briefing on the conclusion of the assessment of the Pharmacovigilance Risk Assessment Committee (PRAC) of Vaxzevria (previously COVID-19 Vaccine AstraZeneca) and thromboembolic events
, Virtual meeting, from 07/04/2021 to 07/04/2021 |
07/04/2021 |
Herbal medicinal product: Tiliae flos , Tiliae flos, C: ongoing call for scientific data
(updated) |
07/04/2021 |
Herbal medicinal product: Salviae miltiorrhizae rhizoma, Salviae miltiorrhizae rhizoma, F: Assessment finalised
(updated) |
07/04/2021 |
Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations
(updated) |
07/04/2021 |
Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms
(updated) |
07/04/2021 |
Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances
(updated) |
07/04/2021 |
Herbal medicinal product: Origani dictamni herba, Origani dictamni herba, C: ongoing call for scientific data
(updated) |
07/04/2021 |
Herbal medicinal product: Paulliniae semen, Paulliniae semen, C: ongoing call for scientific data
(updated) |
07/04/2021 |
Herbal medicinal product: Rhodiolae roseae rhizoma et radix, Rhodiolae roseae rhizoma et radix, C: ongoing call for scientific data
(updated) |
07/04/2021 |
Herbal medicinal product: Urticae radix, Urticae radix, C: ongoing call for scientific data
(updated) |
07/04/2021 |
Herbal medicinal product: Liquiritiae radix, Liquiritiae radix, C: ongoing call for scientific data
(updated) |
07/04/2021 |
Herbal medicinal product: Lichen islandicus, Lichen islandicus, C: ongoing call for scientific data
(updated) |
07/04/2021 |
Herbal medicinal product: Millefolii herba, Millefolii herba, F: Assessment finalised
(updated) |
07/04/2021 |
Herbal medicinal product: Aloysiae folium, Aloysiae citriodorae folium, F: Assessment finalised
(updated) |
07/04/2021 |
Herbal medicinal product: Menthae piperitae aetheroleum, Menthae piperitae aetheroleum, F: Assessment finalised
(updated) |
07/04/2021 |
Herbal medicinal product: Menthae piperitae folium, Menthae piperitae folium, F: Assessment finalised
(updated) |
07/04/2021 |
Herbal medicinal product: Marrubii herba, Marrubii herba, C: ongoing call for scientific data
(updated) |
07/04/2021 |
Orphan designation: Synthetic 12 amino acid peptide designed after subcommissural organ-spondin
for the: Treatment of spinal cord injury, 13/11/2013, Positive (updated) |