Orphan designation: Humanised IgG1 monoclonal antibody against human epidermal growth factor receptor 2 Treatment of gastric cancer, 22/05/2025 Positive

Human medicines European public assessment report (EPAR): BroPair Spiromax, salmeterol,fluticasone propionate, Date of authorisation: 26/03/2021, Revision: 4, Status: Authorised

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

Orphan designation: Taladegib Treatment of idiopathic pulmonary fibrosis, 22/05/2025 Positive

Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin,linagliptin, Date of authorisation: 11/11/2016, Revision: 21, Status: Authorised

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

Ursodeoxycholic acid product-specific bioequivalence guidance

Prasugrel product-specific bioequivalence guidance

Paracetamol product-specific bioequivalence guidance

Oseltamivir product-specific bioequivalence guidance