EMEA-003495-PIP02-24

Opinion/decision on a Paediatric investigation plan (PIP): Agamree, vamorolone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0355/2024

Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: P/0353/2024

Referral: Azithromycin-containing medicinal products for systemic use, azithromycin Article 31 referrals European Commission final decision, 22/05/2025, 08/09/2025, 21/10/2025

Human medicines European public assessment report (EPAR): Voriconazole Accord, voriconazole, Date of authorisation: 16/05/2013, Revision: 22, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Zerbaxa, ceftolozane,tazobactam, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0381/2024

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Press and social media

Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0374/2024

Opinion/decision on a Paediatric investigation plan (PIP): Evenity, romosozumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0375/2024