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

Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Date of authorisation: 26/09/2017, Revision: 35, Status: Authorised

Submitted by Anonymous (not verified) on 15 July 2024 - 13:55

Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Date of authorisation: 26/09/2017, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR): Idefirix, imlifidase, Date of authorisation: 25/08/2020, Revision: 6, Status: Authorised

Submitted by Anonymous (not verified) on 15 July 2024 - 13:26

Human medicines European public assessment report (EPAR): Idefirix, imlifidase, Date of authorisation: 25/08/2020, Revision: 6, Status: Authorised

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

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