New treatment against Duchenne muscular dystrophy

First treatment against severe thyroid eye disease

Summary of opinion: Adempas, 25/05/2025 Positive

Withdrawn application: Ngenla, 20/12/2024

Opinion/decision on a Paediatric investigation plan (PIP): Rydapt, Midostaurin, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps);Oncology, PIP number: P/0068/2024

Opinion/decision on a Paediatric investigation plan (PIP): Enspryng, satralizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders;Neurology, PIP number: P/0069/2024

EMEA-002282-PIP01-17-M02

EMEA-002493-PIP01-18-M06

Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V), Online, from 27 March 2025, 12:30 (CET) to 27 March 2025, 13:00 (CET)

Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Date of authorisation: 12/01/2005, Revision: 65, Status: Authorised