Fludarabine supply shortage
Fludarabine supply shortage
Fludarabine supply shortage
Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0421/2019
EMEA-001312-PIP02-19
EMEA-001312-PIP03-19
Human medicines European public assessment report (EPAR): Zalasta, olanzapine, Date of authorisation: 27/09/2007, Revision: 21, Status: Authorised
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024
Liposomal amphotericin B product-specific bioequivalence guidance
Note on the HORIZON-JU-IHI-2024-06-two-stage funding call: Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence
EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance
EudraVigilance Form A