Presentation - SME info day - Session 4 - EMA activities on medical devices
Submitted by Anonymous (not verified) on 25 November 2024 - 10:20
Presentation - SME info day - Session 4 - EMA activities on medical devices
Clinical Data Publication (Policy 0070) webinar - Step 2, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 November 2024, 15:00 (CET) to 14 November 2024, 16:00 (CET)
Submitted by Anonymous (not verified) on 25 November 2024 - 9:24
Clinical Data Publication (Policy 0070) webinar - Step 2, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 November 2024, 15:00 (CET) to 14 November 2024, 16:00 (CET)
PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC meeting
Submitted by Anonymous (not verified) on 25 November 2024 - 9:20
PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC meeting
New fee regulation: General questions and answers - Annex III
Submitted by Anonymous (not verified) on 22 November 2024 - 15:13
New fee regulation: General questions and answers - Annex III
New fee regulation: General questions and answers - Annex II
Submitted by Anonymous (not verified) on 22 November 2024 - 15:12
New fee regulation: General questions and answers - Annex II
Human medicines European public assessment report (EPAR): Pombiliti, cipaglucosidase alfa, Date of authorisation: 20/03/2023, Revision: 1, Status: Authorised
Submitted by Anonymous (not verified) on 22 November 2024 - 15:08
Human medicines European public assessment report (EPAR): Pombiliti, cipaglucosidase alfa, Date of authorisation: 20/03/2023, Revision: 1, Status: Authorised
Meeting Summary of the Medicine Shortages (SPOC) Working Party meeting 7-8 October 2024
Submitted by Anonymous (not verified) on 22 November 2024 - 13:34
Meeting Summary of the Medicine Shortages (SPOC) Working Party meeting 7-8 October 2024
Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
Submitted by Anonymous (not verified) on 22 November 2024 - 13:31
Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
QRD statements for metered dose inhalers containing fluorinated greenhouse gases
Submitted by Anonymous (not verified) on 22 November 2024 - 13:29
QRD statements for metered dose inhalers containing fluorinated greenhouse gases
Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0417/2023
Submitted by Anonymous (not verified) on 22 November 2024 - 13:19
Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0417/2023