18473 results
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News: Annual report 2020 published (new)
Last updated: 14/06/2021 -
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Annual reports and work programmes (updated)
Last updated: 14/06/2021 -
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EMA regular press briefing on COVID-19 (new)
Virtual meeting, 17/06/2021, Last updated: 14/06/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia (updated)
Date of first decision: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Human medicine European public assessment report (EPAR): Efmody (updated)
hydrocortisone, Adrenal Hyperplasia, Congenital
Date of authorisation: 27/05/2021,
, Authorised, Last updated: 14/06/2021
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Risk management information day 2021 (updated)
Virtual meeting, 15/06/2021, Last updated: 14/06/2021 -
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Deferasirox product-specific bioequivalence guidance (updated)
Last updated: 14/06/2021 -
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Referral: Zynteglo (updated)
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: Under evaluation, Last updated: 11/06/2021 -
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Committee for Orphan Medicinal Products (COMP): 13-15 April 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 13/04/2021 to 15/04/2021, Last updated: 11/06/2021 -
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News: COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality (new)
Last updated: 11/06/2021 -
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COVID-19: latest updates (updated)
Last updated: 11/06/2021 -
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Article 5(3) opinions (updated)
Last updated: 11/06/2021 -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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
Date of authorisation: 06/01/2021,, 
, Revision: 5, Authorised, Last updated: 11/06/2021
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News: Additional manufacturing capacity for Moderna’s COVID-19 vaccine (new)
CHMP, Last updated: 11/06/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021 (new)
PRAC, Last updated: 11/06/2021 -
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News: COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis (new)
PRAC, Last updated: 11/06/2021 -
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News: Vaxzevria: EMA advises against use in people with history of capillary leak syndrome (new)
PRAC, Last updated: 11/06/2021 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development (updated)
Last updated: 11/06/2021 -
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Human medicine European public assessment report (EPAR): Neparvis (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,, Revision: 12, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Entresto (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 19/11/2015, Revision: 13, Authorised, Last updated: 11/06/2021 -
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Human medicine European public assessment report (EPAR): Skyrizi (updated)
Risankizumab, Psoriasis
Date of authorisation: 26/04/2019,, Revision: 5, Authorised, Last updated: 11/06/2021
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Veterinary Big Data stakeholder forum (updated)
Virtual event, from 01/06/2021 to 02/06/2021, Last updated: 11/06/2021 -
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International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
Last updated: 11/06/2021 -
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, 
, Revision: 13, Authorised, Last updated: 11/06/2021
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Committee for Orphan Medicinal Products (COMP): 15-17 June 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 15/06/2021 to 17/06/2021, Last updated: 11/06/2021