Orphan designation: Enzastaurin hydrochloride, Treatment of diffuse large B-cell lymphoma, 20/03/2007, Withdrawn

Orphan designation: Risdiplam, Treatment of spinal muscular atrophy, 26/02/2019, Withdrawn

Orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene, Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 17/01/2018, Withdrawn

Orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene (devafidugene civaparvovec), Treatment of mucopolysaccharidosis type I, 17/01/2018, Withdrawn

Human medicines European public assessment report (EPAR): Pemazyre, pemigatinib, Cholangiocarcinoma, Date of authorisation: 26/03/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Dovato, dolutegravir,lamivudine, HIV Infections, Date of authorisation: 10/06/2022, Revision: 14, Status: Authorised

Questions and answers on labelling flexibilities for COVID-19 vaccines

Labelling flexibilities for COVID-19 therapeutics

Veterinary medicines European public assessment report (EPAR): Nobivac Myxo-RHD, live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009, Date of authorisation: 07/09/2011, Revision: 4, Status: Withdrawn

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Colorectal Neoplasms;Breast Neoplasms;Ovarian Neoplasms;Fallopian Tube Neoplasms;Peritoneal Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms, Date of authorisation: 17/08/2022, Revision: 4, Status: Authorised