19792 results
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Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings (new)
Last updated: 14/06/2030 -
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Reporting safety information on clinical trials (updated)
Last updated: 29/03/2025 -
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Assessment templates and guidance (veterinary medicines) (new)
Last updated: 10/03/2025 -
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Crisis preparedness and management (updated)
Last updated: 13/02/2025 -
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Medicines Shortages Single Point of Contact (SPOC) Working Party (new)
Last updated: 26/09/2024 -
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Human medicine European public assessment report (EPAR): Caprelsa (updated)
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,
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, Revision: 22, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Xelevia (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 34, Authorised, Last updated: 30/06/2022 -
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Public consultation: Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides in food of animal origin (new)
Last updated: 30/06/2022 -
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Human medicine European public assessment report (EPAR): Januvia (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 20/03/2007, Revision: 30, Authorised, Last updated: 30/06/2022 -
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News: Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU (new)
CVMP, Last updated: 30/06/2022 -
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Clinical Trials Information System (CTIS) webinar: Six months of CTIS and looking forward (updated)
Online, 09:30-13:30 Amsterdam time (CEST), 01/07/2021, Last updated: 30/06/2022 -
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Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,
, Revision: 2, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Rapiscan (updated)
regadenoson, Myocardial Perfusion Imaging
Date of authorisation: 06/09/2010, Revision: 14, Authorised, Last updated: 30/06/2022 -
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Human medicine European public assessment report (EPAR): Velmetia (updated)
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/07/2008, Revision: 32, Authorised, Last updated: 30/06/2022 -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 14, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Tesavel (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 10/01/2008, Revision: 26, Authorised, Last updated: 30/06/2022 -
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Human medicine European public assessment report (EPAR): Memantine ratiopharm (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 12/06/2013,, Revision: 8, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): HyQvia (updated)
Human normal immunoglobulin, Immunologic Deficiency Syndromes
Date of authorisation: 16/05/2013,, Revision: 18, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, 
, , Revision: 13, Authorised, Last updated: 30/06/2022
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Orphan designation: Rezafungin acetate for: Treatment of invasive candidiasis (updated)
Date of designation: 06/01/2021, Positive, Last updated: 30/06/2022 -
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Orphan designation: Recombinant human monoclonal antibody to insulin receptor for: Treatment of congenital hyperinsulinism (updated)
Date of designation: 14/07/2016, Positive, Last updated: 30/06/2022 -
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Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm (new)
Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 30/06/2022 -
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Procurement activities 2021 (new)
Last updated: 30/06/2022 -
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Human medicine European public assessment report (EPAR): Saxenda (updated)
liraglutide, Obesity; Overweight
Date of authorisation: 23/03/2015, Revision: 12, Authorised, Last updated: 29/06/2022 -
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Orphan designation: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate (enasidenib) for: Treatment of acute myeloid leukaemia (updated)
Date of designation: 28/04/2016, Positive, Last updated: 29/06/2022