Human medicines European public assessment report (EPAR): Abiraterone Accord, abiraterone, Prostatic Neoplasms, Date of authorisation: 26/04/2021, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Hyftor, sirolimus, Angiofibroma;Tuberous Sclerosis, Date of authorisation: 15/05/2023, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Invirase, saquinavir, HIV Infections, Date of authorisation: 03/10/1996, Revision: 50, Status: Withdrawn

Human medicines European public assessment report (EPAR): ellaOne, ulipristal acetate, Contraception, Postcoital, Date of authorisation: 15/05/2009, Revision: 30, Status: Authorised

Questions and answers on the assessment of the deficiencies in the safety reporting system at Roche Registration Ltd

Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia;Bipolar Disorder, Date of authorisation: 12/12/2007, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Diabetes Mellitus, Date of authorisation: 24/05/2018, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Orphacol, cholic acid, Digestive System Diseases;Metabolism, Inborn Errors, Date of authorisation: 12/09/2013, Date of refusal: 25/05/2012, Revision: 13, Status: Authorised

Orphan designation: cholic acid, Treatment of inborn errors in primary bile acid synthesis, 18/12/2002, Positive

List of signals discussed at PRAC since September 2012