WhinRho SDF 1500 IU / 5000 IU: withdrawal from the market

Following an European  referral, it appears that the medicines WinRho SDF 1500 IU and WinRho 5000 IU have an unfavorable benefit / risk ratio for the "treatment of immune thrombocytopenic purpura (ITP)”.
The Marketing Authorization (MA) of these medicines has been withdrawn at the request of the MA holder (Cangene Europe Ltd). The distribution of these medicines has been stopped and batches still on the market have been recalled.

The medicines WinRho SDF 1500 IU and WinRho 5000 IU in powder and solvent form for solution for infusion and for injection were authorized in Belgium via a mutual recognition procedure (RMP) with the United Kingdom as reference member state. During the Procedure UK/H/634/02-03/E/01 and to extend the MA to other member states, it has emerged that these medicines have an unfavorable benefit / risk ratio for "treatment of immune thrombocytopenic purpura (ITP”). Referral was initiated by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on the basis of Article 29 (4) of Directive 2001/83/EC as amended by Directive 2004/27/EC.

Following the initiation of this referral by the CHMP, the MA holder has requested the withdrawal of marketing authorization for medicines WinRho SDF 1500 IU and WinRho 5000 IU in powder and solvent form for solution for infusion and for injection.
The distribution of these two medicines has been stopped.
Given that this withdrawal was made in response to a potential risk to public health (cases of intravascular hemolysis and complications), the batches still on the market have been recalled.

Last updated on
26/08/2009