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

Human medicines European public assessment report (EPAR): Lenalidomide Accord, lenalidomide, Multiple Myeloma, Date of authorisation: 20/09/2018, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Rybrevant, amivantamab, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 09/12/2021, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 22/11/2018, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), tobramycin, Respiratory Tract Infections;Cystic Fibrosis, Date of authorisation: 18/02/2019, Revision: 5, Status: Authorised