What's new

What's new

Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)

Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)

18 April 2024

Timetable: Extension application

Timetable: Extension application

18 April 2024

Timetable: Initial (full) marketing authorisation application accelerated assessment timetables

Timetable: Initial (full) marketing authorisation application accelerated assessment timetables

18 April 2024

Timetable accelerated assessment request for initial marketing authorisation applications

Timetable accelerated assessment request for initial marketing authorisation applications

18 April 2024

Timetable: Extension application - ATMP

Timetable: Extension application - ATMP

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

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

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

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

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

Human medicines European public assessment report (EPAR): Cystagon, mercaptamine bitartrate, Date of authorisation: 23/06/1997, Revision: 18, Status: Authorised

18 April 2024