Opinion/decision on a Paediatric investigation plan (PIP): Cibinqo, abrocitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0454/2023

Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0482/2023

Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0482/2023

EMEA-001931-PIP01-16-M03

EMEA-001925-PIP02-19-M01

EMEA-002582-PIP01-19-M03

Orphan designation: Avenciguat Treatment of systemic sclerosis, 11/11/2024 Positive

Orphan designation: Curcumin E100, Resveratrol Treatment of Dercum disease, 11/11/2024 Positive

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

Orphan designation: 4-[[(4-Methoxyphenyl)thio]methyl]-N,N-dimethyl-1H-1,2,3-triazole-1-ethanamine Treatment of non-syndromic inherited retinal dystrophies with a rod-dominant phenotype, 11/11/2024 Positive