Guidance and template for industry on implementing Shortage Prevention Plans (SPP)
Guidance and template for industry on implementing Shortage Prevention Plans (SPP)
Guidance and template for industry on implementing Shortage Prevention Plans (SPP)
Timetable: Companion diagnostic follow-up consultation
Timetable: Companion diagnostic follow-up consultation - ATMP
Timetable: Companion diagnostic initial consultation
Timetable: Companion diagnostic initial consultation - ATMP
Timetable: Type II variation and worksharing application monthly assessment
Human medicines European public assessment report (EPAR): Arexvy, Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted), Date of authorisation: 06/06/2023, Revision: 12, Status: Authorised
Human medicines European public assessment report (EPAR): Kesimpta, ofatumumab, Date of authorisation: 26/03/2021, Revision: 16, Status: Authorised
Human medicines European public assessment report (EPAR): Ryeqo, relugolix,estradiol,norethisterone acetate, Date of authorisation: 16/07/2021, Revision: 9, Status: Authorised
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