🇪🇺 Darbepoetin alpha in European Union

EMA authorised Darbepoetin alpha on 8 June 2001

Marketing authorisation

EMA — authorised 8 June 2001

• Application: EMEA/H/C/000332
• Marketing authorisation holder: Amgen Europe B.V.
• Local brand name: Aranesp
• Indication: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
• Status: approved

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Frequently asked questions

Is Darbepoetin alpha approved in European Union?

Yes. EMA authorised it on 8 June 2001.

Who is the marketing authorisation holder for Darbepoetin alpha in European Union?

Amgen Europe B.V. holds the EU marketing authorisation.