Medicinal Product master data for better regulation and better health - Network Data Steering Group (NDSG) recommendations for human Product Master Data implementation and data management

Medicinal Product master data for better regulation and better health - Network Data Steering Group (NDSG) recommendations for human Product Master Data implementation and data management

Human medicines European public assessment report (EPAR): Sorafenib Accord, sorafenib, Date of authorisation: 09/11/2022, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Sorafenib Accord, sorafenib, Date of authorisation: 09/11/2022, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Date of authorisation: 22/05/2014, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Date of authorisation: 22/05/2014, Revision: 32, Status: Authorised

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

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): BroPair Spiromax, salmeterol,fluticasone propionate, Date of authorisation: 26/03/2021, Revision: 4, 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

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

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