Opinion/decision on a Paediatric investigation plan (PIP): Spevigo, Spesolimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0247/2023

Submitted by Anonymous (not verified) on 15 July 2024 - 16:26

Opinion/decision on a Paediatric investigation plan (PIP): Spevigo, Spesolimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0247/2023

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

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)

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

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