Human medicines European public assessment report (EPAR): Levetiracetam Actavis, levetiracetam, Date of authorisation: 03/10/2011, Revision: 20, Status: Authorised

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Orphan designation: 1-{4-[2-(5-ethoxymethyl-2-methyl-phenylamino)-oxazol-5-yl]-phenyl}-imidazolidin-2-one Treatment of acute myeloid leukaemia, 22/05/2025 Positive

Guidance on the application of the revised variations framework

Ursodeoxycholic acid product-specific bioequivalence guidance

Prasugrel product-specific bioequivalence guidance

Paracetamol product-specific bioequivalence guidance

Oseltamivir product-specific bioequivalence guidance

Metformin product-specific bioequivalence guidance