🇪🇺 RO0503821 (1x/2 Weeks) in European Union

EMA authorised RO0503821 (1x/2 Weeks) on 20 July 2007

Marketing authorisation

EMA — authorised 20 July 2007

  • Application: EMEA/H/C/000739
  • Marketing authorisation holder: Roche Registration GmbH
  • Local brand name: Mircera
  • Indication: Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1). Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1).
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is RO0503821 (1x/2 Weeks) approved in European Union?

Yes. EMA authorised it on 20 July 2007.

Who is the marketing authorisation holder for RO0503821 (1x/2 Weeks) in European Union?

Roche Registration GmbH holds the EU marketing authorisation.