List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

Human medicines European public assessment report (EPAR): Gliolan, 5-aminolevulinic acid hydrochloride, Date of authorisation: 07/09/2007, Revision: 10, Status: Authorised

mHealth data for real world evidence in regulatory decision-making: expert report for HMA-EMA Big Data Steering Group

Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin, Date of authorisation: 11/11/2012, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Edistride, dapagliflozin, Date of authorisation: 09/11/2015, Revision: 25, Status: Authorised

Scientific Symposium on Advanced Therapy Medicinal Products - ‘Contribution, evolution, revolution’, European Medicines Agency, Amsterdam, the Netherlands, from 10 October 2024, 09:00 (CEST) to 10 October 2024, 17:00 (CEST)

PSUSA/00000126/202401

Human medicines European public assessment report (EPAR): Zavesca, miglustat, Date of authorisation: 20/11/2002, Date of refusal: 16/06/2009, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR): Translarna, ataluren, Date of authorisation: 31/07/2014, Revision: 24, Status: Authorised