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Last updated about 19 hours ago
Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 1 (veterinary)
about 19 hours ago
Template - Application for transfer of marketing authorisation from transferor to transferee...
Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Date of authorisation: 26/07/2018, Revision: 10, Status: Authorised
about 21 hours ago
Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Date of authorisation...
Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda
about 22 hours ago
Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA...
List of medicinal products under additional monitoring
about 22 hours ago
List of medicinal products under additional monitoring
List of medicines under additional monitoring
about 22 hours ago
List of medicines under additional monitoring
List of medicinal products under additional monitoring
about 22 hours ago
List of medicinal products under additional monitoring
List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
about 22 hours ago
List of European Union reference dates (EURD) and frequency of submission of...
Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Date of authorisation: 30/06/2026, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Itvisma, onasemnogene abeparvovec, Date of...
Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 35, Status: Withdrawn
1 day ago
Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation...
Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised
3 days ago
Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of...
Human medicines European public assessment report (EPAR): Macitentan AccordPharma, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised
3 days ago
Human medicines European public assessment report (EPAR): Macitentan AccordPharma, macitentan, Date of...
Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Date of authorisation: 19/01/2007, Revision: 33, Status: Authorised
3 days ago
Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop)...