Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) - Scientific guideline

List of medicines currently in PRIME scheme

Human medicines European public assessment report (EPAR): Ertapenem SUN, ertapenem, Date of authorisation: 15/07/2022, Revision: 2, Status: Authorised

List of medicines currently in PRIME scheme

Veterinary medicines European public assessment report (EPAR): Bovilis Nasalgen-C, bovine coronavirus, strain CA25, live, Status: Authorised

Committee for Orphan Medicinal Products (COMP): 13-15 February 2024, European Medicines Agency, Amsterdam, the Netherlands, from 13 February 2024 to 15 February 2024

Marketing authorisation templates

Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)

Orphan designation: Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt (cabozantinib) Treatment of medullary thyroid carcinoma, 06/02/2009 Positive

Herbal medicinal product: Oenotherae oleumArray, C: ongoing call for scientific data