Human medicines European public assessment report (EPAR): Imreplys, sargramostim, Date of authorisation: 21/08/2025, Status: Authorised
Severe cutaneous adverse reactions - standard template wording for product information
EMEA-002554-PIP02-19
EMEA-003521-PIP01-23
Human medicines European public assessment report (EPAR): Anagrelide Viatris (previously Anagrelide Mylan), anagrelide, Date of authorisation: 15/02/2018, Revision: 12, Status: Authorised
Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Date of authorisation: 26/04/2019, Revision: 20, Status: Authorised
Incident management plan
Human medicines European public assessment report (EPAR): Ranivisio, ranibizumab, Date of authorisation: 25/08/2022, Revision: 7, Status: Authorised
PMS Product user interface (PUI) Training: Product data submission & bulk edit made easy, Online, European Medicines Agency, Amsterdam, the Netherlands, from 6 October 2025, 10:00 (CEST) to 6 October 2025, 12:00 (CEST)
Human medicines European public assessment report (EPAR): Kizfizo, temozolomide, Date of refusal: 02/05/2025, Status: Refused