Orphan designation: Celecoxib,Ciprofloxacin, Treatment of amyotrophic lateral sclerosis, 06/01/2021, Positive

Human medicines European public assessment report (EPAR): Steglujan, ertugliflozin,sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: 23/03/2018, Revision: 11, Status: Authorised

Committee for Advanced Therapies (CAT): 12-14 July 2023, European Medicines Agency, Amsterdam, the Netherlands, from 12/07/2023 to 14/07/2023

Human medicines European public assessment report (EPAR): Tesavel, sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: 10/01/2008, Revision: 28, Status: Authorised

Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, Date of authorisation: 31/08/2018, Revision: 8, Status: Authorised

Committee for Orphan Medicinal Products (COMP): 11-13 July 2023, European Medicines Agency, Amsterdam, the Netherlands, from 11/07/2023 to 13/07/2023

Human medicines European public assessment report (EPAR): Apealea, paclitaxel, Ovarian Neoplasms, Date of authorisation: 20/11/2018, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Januvia, sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: 20/03/2007, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Litfulo, ritlecitinib, Alopecia Areata, Date of authorisation: 15/09/2023, Status: Authorised

Questions and answers for biological medicinal products