Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors
Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors
Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors
Human medicines European public assessment report (EPAR): Nexium Control, esomeprazole, Date of authorisation: 26/08/2013, Revision: 20, Status: Authorised
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Procedural advice for orphan medicinal product designation: Guidance for sponsors
Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Date of authorisation: 19/01/2007, Revision: 31, Status: Authorised
Human medicines European public assessment report (EPAR): Celldemic, zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures), Date of authorisation: 19/04/2024, Revision: 1, Status: Authorised
Referral: Metamizole-containing medicinal products, metamizole Article 107i procedures European Commission final decision, 22/11/2024, 29/01/2025
Human medicines European public assessment report (EPAR): Edarbi, azilsartan medoxomil, Date of authorisation: 07/12/2011, Revision: 12, Status: Authorised