Timetable: Type II variation and worksharing application assessment - ATMP
Submitted by Anonymous (not verified) on 23 October 2024 - 15:16
Timetable: Type II variation and worksharing application assessment - ATMP
Timetable: Type IB variation requiring linguistic review
Submitted by Anonymous (not verified) on 23 October 2024 - 15:15
Timetable: Type IB variation requiring linguistic review
Presentation - Product Management Service (PMS) Product UI training (access and navigation)
Submitted by Anonymous (not verified) on 23 October 2024 - 14:50
Presentation - Product Management Service (PMS) Product UI training (access and navigation)
Human medicines European public assessment report (EPAR): Memantine LEK, memantine, Date of authorisation: 21/04/2013, Date of refusal: 21/02/2013, Revision: 5, Status: Withdrawn (authorisation)
Submitted by Anonymous (not verified) on 23 October 2024 - 11:20
Human medicines European public assessment report (EPAR): Memantine LEK, memantine, Date of authorisation: 21/04/2013, Date of refusal: 21/02/2013, Revision: 5, Status: Withdrawn (authorisation)
List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Submitted by Anonymous (not verified) on 23 October 2024 - 9:35
List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Orphan designation: milademetan tosilate monohydrate Treatment of soft tissue sarcoma, 20/03/2017 Positive
Submitted by Anonymous (not verified) on 23 October 2024 - 9:00
Orphan designation: milademetan tosilate monohydrate Treatment of soft tissue sarcoma, 20/03/2017 Positive
Orphan designation: Recombinant adeno-associated viral vector serotype 9 containing the human N-alpha-acetylglucosaminidase gene Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 12/01/2017 Positive
Submitted by Anonymous (not verified) on 23 October 2024 - 8:57
Orphan designation: Recombinant adeno-associated viral vector serotype 9 containing the human N-alpha-acetylglucosaminidase gene Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 12/01/2017 Positive
Orphan designation: ganglioside GM1 Treatment of amyotrophic lateral sclerosis, 13/04/2021 Positive
Submitted by Anonymous (not verified) on 23 October 2024 - 8:56
Orphan designation: ganglioside GM1 Treatment of amyotrophic lateral sclerosis, 13/04/2021 Positive
Orphan designation: Rilonacept Treatment of idiopathic pericarditis, 06/01/2021 Positive
Submitted by Anonymous (not verified) on 23 October 2024 - 8:41
Orphan designation: Rilonacept Treatment of idiopathic pericarditis, 06/01/2021 Positive
Orphan designation: Soticlestat Treatment of Lennox-Gastaut syndrome, 12/11/2021 Positive
Submitted by Anonymous (not verified) on 23 October 2024 - 8:35
Orphan designation: Soticlestat Treatment of Lennox-Gastaut syndrome, 12/11/2021 Positive