Agenda - Joint HMA/EMA Big Data Steering Group Workshop on RWE methods

Human medicines European public assessment report (EPAR): Teriflunomide Accord, teriflunomide, Date of authorisation: 09/11/2022, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Sifrol, pramipexole, Date of authorisation: 13/10/1997, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Quviviq, daridorexant, Date of authorisation: 29/04/2022, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Nepexto, etanercept, Date of authorisation: 20/05/2020, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Tecartus, Brexucabtagene autoleucel, Date of authorisation: 14/12/2020, Revision: 7, Status: Authorised

List of eligible industry stakeholder organisations

Human medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune), pandemic influenza vaccine (H5N1) (live attenuated, nasal), Date of authorisation: 20/05/2016, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Spedra, avanafil, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 14, Status: Authorised