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

Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, Date of authorisation: 25/07/2008, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR): Rivastigmine Sandoz, rivastigmine, Dementia;Alzheimer Disease;Parkinson Disease, Date of authorisation: 10/12/2009, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Imbruvica, ibrutinib, Lymphoma, Mantle-Cell;Leukemia, Lymphocytic, Chronic, B-Cell, Date of authorisation: 21/10/2014, Revision: 31, Status: Authorised

Good clinical practice (GCP) inspection procedures