CHMP positive for Mircera to treat paediatric patients with anaemia associated with CKD – Roche

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mircera (methoxypolyethylene glycolepoetin beta). The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

The CHMP adopted an extension to an existing indication for use in paediatric patients. For information, the full indications for Mircera will be as follows: i. Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients. ii. 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 erythropoietin stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA