Opinion/decision on a Paediatric investigation plan (PIP): Vanflyta, Quizartinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP

Submitted by Anonymous (not verified) on 24 June 2025 - 17:04

Opinion/decision on a Paediatric investigation plan (PIP): Vanflyta, Quizartinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0203/2024

Human medicines European public assessment report (EPAR): Beyonttra, acoramidis, Date of authorisation: 10/02/2025, Revision: 1, Status: Authorised

Submitted by Anonymous (not verified) on 24 June 2025 - 16:28

Human medicines European public assessment report (EPAR): Beyonttra, acoramidis, Date of authorisation: 10/02/2025, Revision: 1, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Ebglyss, Lebrikizumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Respiratory, thoracic and mediastinal disorders, PIP numb

Submitted by Anonymous (not verified) on 24 June 2025 - 16:26

Opinion/decision on a Paediatric investigation plan (PIP): Ebglyss, Lebrikizumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Respiratory, thoracic and mediastinal disorders, PIP number: P/0212/2024

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