ZURICH (Thomson Financial) - Roche Holding AG said the European Commission has approved Mircera for the treatment of anaemia associated with chronic kidney disease (CKD).
The approval of Mircera results in a single marketing authorisation with unified labelling for all EU member states.
The Commission's decision follows a Positive Opinion by the Committee for Medicinal Products for Human Use (CHMP) in May 2007.
Mircera, is the first erythropoietin receptor activator, approved in the EU that offers a convenient dosing schedule of once every two weeks to correct anaemia in patients not previously treated, Roche said. andrew.ge.thompson@thomson.com at/jlw COPYRIGHT Copyright AFX News Limited 2007. All rights reserved. The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
The approval of Mircera results in a single marketing authorisation with unified labelling for all EU member states.
The Commission's decision follows a Positive Opinion by the Committee for Medicinal Products for Human Use (CHMP) in May 2007.
Mircera, is the first erythropoietin receptor activator, approved in the EU that offers a convenient dosing schedule of once every two weeks to correct anaemia in patients not previously treated, Roche said. andrew.ge.thompson@thomson.com at/jlw COPYRIGHT Copyright AFX News Limited 2007. All rights reserved. The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
© 2007 AFX News
