20654 results
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ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Scientific guideline (updated)
Last updated: 06/10/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
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News: EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants (new)
Last updated: 06/06/2023 -
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Webinar on Nationally Authorised Products (NAPs) release on Product Lifecycle Management (PLM) Portal electronic Application Forms (eAFs) (updated)
Online, 10:00 - 11:30 Amsterdam time (CEST), 08/06/2023, Last updated: 06/06/2023 -
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Union Product Database: release notes (updated)
Last updated: 06/06/2023 -
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PRIME: priority medicines (updated)
Last updated: 06/06/2023 -
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COVID-19: latest updates (updated)
Last updated: 05/06/2023 -
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,
, Revision: 20, Authorised, Last updated: 05/06/2023
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Orphan designation: Citric acid monohydrate for: Treatment of acute liver failure (updated)
Date of designation: 27/06/2016, Positive, Last updated: 05/06/2023 -
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Orphan designation: 4,7,10,13,16,19-docosahexaenoic acid for: Treatment of retinitis pigmentosa (updated)
Date of designation: 04/11/2006, Positive, Last updated: 05/06/2023 -
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Orphan designation: 5'-ASCSASTSCSASGSTSCSTSGSASUSASASGSCSTSA-3' (lademirsen) for: Treatment of Alport syndrome (updated)
Date of designation: 19/03/2015, Withdrawn, Last updated: 05/06/2023 -
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Human medicine European public assessment report (EPAR): SonoVue (updated)
sulphur hexafluoride, Ultrasonography; Echocardiography
Date of authorisation: 26/03/2001, Revision: 20, Authorised, Last updated: 05/06/2023 -
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Human medicine European public assessment report (EPAR): Tezspire (updated)
tezepelumab, Asthma
Date of authorisation: 19/09/2022,
, Revision: 4, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 5, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Xerava (updated)
eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018,, Revision: 7, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Lacosamide Adroiq (updated)
lacosamide, Epilepsy
Date of authorisation: 31/05/2023,
, Authorised, Last updated: 05/06/2023
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PRAC recommendations on safety signals (updated)
Last updated: 05/06/2023 -
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Pharmaceutical industry (updated)
Last updated: 02/06/2023 -
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Academia (updated)
Last updated: 02/06/2023 -
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, 
, , Revision: 11, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Adynovi (updated)
rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018,, Revision: 9, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,
, , Revision: 15, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Oxervate (updated)
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,, , , Revision: 2, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Cosentyx (updated)
Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing
Date of authorisation: 14/01/2015, Revision: 32, Authorised, Last updated: 02/06/2023 -
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European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting (updated)
Amsterdam, 28/06/2023, Last updated: 02/06/2023