Human medicines European public assessment report (EPAR): Balversa, Erdafitinib, Date of authorisation: 22/08/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Apretude, cabotegravir, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Date of authorisation: 09/03/2000, Revision: 32, Status: Authorised

Clinical Trial Information System (CTIS) - Sponsor handbook

Generic and hybrid applications

Human medicines European public assessment report (EPAR): Galvus, vildagliptin, Date of authorisation: 25/09/2007, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR): Flucelvax Tetra, influenza vaccine (surface antigen, inactivated, prepared in cell cultures), Date of authorisation: 12/12/2018, Revision: 17, Status: Authorised

Artificial intelligence

Human medicines European public assessment report (EPAR): GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.), budesonide,formoterol fumarate dihydrate, Date of authorisation: 03/04/2020, Revision: 6, Status: Authorised

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human