Human medicines European public assessment report (EPAR): Abiraterone Mylan, abiraterone acetate, Prostatic Neoplasms, Date of authorisation: 20/08/2021, Revision: 4, Status: Authorised

Orphan designation: Lentiviral vector carrying the Fanconi anaemia-A (FANCA) gene, Treatment of Fanconi anaemia type A, 17/12/2010, Positive

Human medicines European public assessment report (EPAR): Lonsurf, trifluridine,tipiracil, Colorectal Neoplasms, Date of authorisation: 25/04/2016, Revision: 9, Status: Authorised

Composition of the Emergency Task Force (ETF) for preparedness

Orphan designation: 2',3',5'-Tri-O-acetyluridine, Treatment of 5-fluorouracil overdose, 15/05/2009, Positive

Human medicines European public assessment report (EPAR): Tremelimumab AstraZeneca, tremelimumab, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 20/02/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Teriparatide Sun, teriparatide, Osteoporosis;Osteoporosis, Postmenopausal, Date of authorisation: 18/11/2022, Revision: 1, Status: Authorised

Levobupivacaine : List of nationally authorised medicinal products - PSUSA/00001848/202212

Timetable: Safety referral (Article 107i, urgent Union procedure)

Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance)