NeLM news service
EC issues positive opinion recommending approval of subcutaneous epoetin zeta (Retacrit) for the treatment of renal anaemia

Source: Personal Communication from MSD-Plough

Date published: 23/02/2010 15:58

Summary
by: Hina Radia

Hospira has announced that the European Committee for Medicinal Products for Human Use (CHMP) has recommended for approval the administration of Retacrit (epoetin zeta) subcutaneously for the management of renal anaemia.

 
The recommendation for approval of Retacrit SC administration follows the submission of data from a rigorous phase III clinical trial demonstrating comparable efficacy and safety between epoetin zeta and the reference product, epoetin alfa, when administered subcutaneously in patients with end-stage renal failure on chronic haemodialysis.

 

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