- MedDRA Important medical event terms list – version 26.1
- Vaccine Monitoring Platform
- European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, Online, from 19/09/2023 to 20/09/2023
- Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium,formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Revision: 6, Status: Authorised
- PRAC: Agendas, minutes and highlights
- 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report (EPAR): Invirase, saquinavir, HIV Infections, Date of authorisation: 03/10/1996, Revision: 50, Status: Withdrawn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
- 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): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Revision: 10, 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