Mircera (methoxy polyethylene glycol-epoetin beta)
- Region
- 🇪🇺 EU
- Active substance
- methoxy polyethylene glycol-epoetin beta
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Anemia; Kidney Failure, Chronic
- EU approval
- Fri 20 Jul 2007
- Application
- EMEA/H/C/000739
- ATC
- B03XA03
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.