Agenda of the CVMP meeting 16-18 July 2024
Submitted by Anonymous (not verified) on 15 July 2024 - 14:29
Agenda of the CVMP meeting 16-18 July 2024
Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
Submitted by Anonymous (not verified) on 15 July 2024 - 10:59
Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
Applications for new human medicines under evaluation: July 2024
Submitted by Anonymous (not verified) on 15 July 2024 - 10:29
Applications for new human medicines under evaluation: July 2024
Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 22 May 2024, 10:00 (CEST) to 22 May 2024, 13:30 (CEST)
Submitted by Anonymous (not verified) on 15 July 2024 - 10:26
Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 22 May 2024, 10:00 (CEST) to 22 May 2024, 13:30 (CEST)
Meeting summary - Medicine Shortages SPOC Working Party meeting on 22 May 2024
Submitted by Anonymous (not verified) on 15 July 2024 - 10:25
Meeting summary - Medicine Shortages SPOC Working Party meeting on 22 May 2024
Opinion/decision on a Paediatric investigation plan (PIP): Sotyktu, Deucravacitinib, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P
Submitted by Anonymous (not verified) on 12 July 2024 - 16:20
Opinion/decision on a Paediatric investigation plan (PIP): Sotyktu, Deucravacitinib, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0250/2023
Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/02
Submitted by Anonymous (not verified) on 12 July 2024 - 16:16
Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0282/2023
List of industry subject matter experts and list of planned calls for industry subject matter experts
Submitted by Anonymous (not verified) on 12 July 2024 - 15:35
List of industry subject matter experts and list of planned calls for industry subject matter experts
Herbal medicinal product: Pelargonii radixArray,Array, F: Assessment finalised
Submitted by Anonymous (not verified) on 12 July 2024 - 15:20
Herbal medicinal product: Pelargonii radixArray,Array, F: Assessment finalised
Public webinar on pack size submissions: from XEVMPD to product management service (PMS), Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 July 2024, 10:00 (CEST) to 11 July 2024, 11:30 (CEST)
Submitted by Anonymous (not verified) on 12 July 2024 - 15:08
Public webinar on pack size submissions: from XEVMPD to product management service (PMS), Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 July 2024, 10:00 (CEST) to 11 July 2024, 11:30 (CEST)