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European Commission grants approval of Zutectra(R)
* Worldwide the first ready-to-use Hepatitis B Immunoglobulin solution for subcutaneous administration
* Marketing in Europe can start now

Dreieich, GERMANY | December 3, 2009 | The European Commission has granted marketing approval to Biotest for the hepatitis B immunoglobulin Zutectra(R) after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) had adopted a positive opinion for approval at the end of September. With this approval the product can be marketed in all EU-member countries.

Zutectra(R) was specifically developed by Biotest for the long-term treatment of patients after liver transplantation. It is worldwide the first ready-to-use hepatitis B immunoglobulin solution in a pre-filled syringe for subcutaneous administration and it enables patients to self-medication. This provides the attending physicians and patients with a time-saving and simpler treatment option.

The positive assessment is based on comprehensive data available to the EMEA, which was reviewed as part of the centralised approval procedure.

SOURCE: Biotest AG

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