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Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)
18 April 2024
Timetable: Initial (full) marketing authorisation application accelerated assessment timetables
18 April 2024
Timetable accelerated assessment request for initial marketing authorisation applications
18 April 2024
Human medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan, sitagliptin hydrochloride monohydrate,metformin hydrochloride, Date of authorisation: 16/02/2022, Revision: 3, Status: Authorised
18 April 2024
Timetable: Companion diagnostic initial consultation - ATMP
18 April 2024
Human medicines European public assessment report (EPAR): Inflectra, infliximab, Date of authorisation: 10/09/2013, Revision: 30, Status: Authorised
18 April 2024
Human medicines European public assessment report (EPAR): Lenvima, lenvatinib, Date of authorisation: 28/05/2015, Revision: 21, Status: Authorised
18 April 2024
Human medicines European public assessment report (EPAR): Cystagon, mercaptamine bitartrate, Date of authorisation: 23/06/1997, Revision: 18, Status: Authorised
18 April 2024