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What's new
What's new
Opinion/decision on a Paediatric investigation plan (PIP): Opdualag, nivolumab,Relatlimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0169/2024
Opinion/decision on a Paediatric investigation plan (PIP): Opdualag, nivolumab,Relatlimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0169/2024
6 June 2025
Opinion/decision on a Paediatric investigation plan (PIP): Rybrevant, amivantamab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0166/2024
Opinion/decision on a Paediatric investigation plan (PIP): Rybrevant, amivantamab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0166/2024
6 June 2025
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: Skin and subcutaneous tissue disorders, PIP number: P/0157/2024
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: Skin and subcutaneous tissue disorders, PIP number: P/0157/2024
6 June 2025
Opinion/decision on a Paediatric investigation plan (PIP): Ztalmy, Ganaxolone, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0183/2024
Opinion/decision on a Paediatric investigation plan (PIP): Ztalmy, Ganaxolone, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0183/2024
6 June 2025
Human medicines European public assessment report (EPAR): Imuldosa, ustekinumab, Date of authorisation: 12/12/2024, Revision: 1, Status: Authorised
Human medicines European public assessment report (EPAR): Imuldosa, ustekinumab, Date of authorisation: 12/12/2024, Revision: 1, Status: Authorised
6 June 2025
Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran,Tozinameran / famtozinameran,tozinameran/ riltozinameran,raxtozinameran, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0105/2024
Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran,Tozinameran / famtozinameran,tozinameran/ riltozinameran,raxtozinameran, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0105/2024
6 June 2025