Outcomes of imposed non-interventional post-authorisation safety studies

Human medicines European public assessment report (EPAR): Praluent, alirocumab, Dyslipidemias, Date of authorisation: 23/09/2015, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: 21/03/2007, Revision: 39, Status: Authorised

Omega-3-acid ethyl esters : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010312/202301

Human medicines European public assessment report (EPAR): Rubraca, rucaparib, Ovarian Neoplasms, Date of authorisation: 23/05/2018, Revision: 15, Status: Authorised

Omega-3-acid ethyl esters : List of nationally authorised medicinal products - PSUSA-00010312-202301

Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, Date of authorisation: 23/07/2012, Revision: 38, Status: Authorised

Human medicines European public assessment report (EPAR): Inaqovi, cedazuridine,decitabine, Leukemia, Myeloid, Date of authorisation: 15/09/2023, Status: Authorised

Human medicines European public assessment report (EPAR): Yuflyma, adalimumab, Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Crohn Disease;Arthritis, Juvenile Rheumatoid, Date of authorisation: 11/02/2021, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Ventavis, iloprost, Hypertension, Pulmonary, Date of authorisation: 15/09/2003, Revision: 30, Status: Authorised