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

Orphan designation: 3-chloro-4-fluorophenyl-(4-fluoro-4-(((5-methylpyrimidin-2-ylmethyl)amino)methyl)piperidin-1yl)methanone Treatment of fragile X syndrome, 11/11/2024 Positive

Human medicines European public assessment report (EPAR): Bydureon, exenatide, Date of authorisation: 17/06/2011, Revision: 27, Status: Authorised

List of industry subject matter experts and list of planned calls for industry subject matter experts