Orphan designation: octreotide hydrochloride Treatment of autosomal dominant polycystic liver disease, 10/11/2024 Positive

Nitrosamine impurities in specific medicines

Scientific review on the risk of nitrosamine impurities in human medicines

Nitrosamine impurities

Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine Treatment of fragile X syndrome, 20/04/2017 Withdrawn

Orphan designation: Live attenuated Listeria monocytogenes transfected with plasmids encoding the HPV-16E7 protein fused to a truncated fragment of the Lm protein listeriolysin O Treatment of anal cancer, 11/01/2016 Withdrawn

Orphan designation: Pamrevlumab Treatment of Duchenne muscular dystrophy, 16/12/2019 Withdrawn

Dates of 2025 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests

Human medicines European public assessment report (EPAR): Ganfort, bimatoprost,timolol, Date of authorisation: 19/05/2006, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Lumigan, bimatoprost, Date of authorisation: 08/03/2002, Revision: 38, Status: Authorised