Pharmacovigilance

Dear Healthcare Professional Letter to physicians concerning supply shortage of Fabrazyme (agalsidase beta) with revised temporary treatment recommendations

29.09.2009

The marketing authorisation holder in the Republic of Croatia for Genezyme Corporation's medicinal products, Medical Intertrade d.o.o., in cooperation with the Agency for Medicinal Products and Medical Devices sent a letter to prescribing physicians concerning supply shortage of Fabrazyme (agalsidase beta). The letter contains the new, revised temporary treatment recommendations compared to those published in July 2009.

Genzyme Corporation, in cooperation with the European Medicines Agency (EMEA), revised the temporary recommendations for treatment of patients suffering from Fabry disease to be implemented in the treatment during the supply shortage in the market.

This notification is not applicable to the patients suffering from Fabry disease in the Republic of Croatia who are receiving Fabrazyme from donation programme and their supply until the end of the year is guaranteed.

The text of the letter can be found below:
Dear Healthcare Professional Letter to physicians concerning supply of Fabrazyme (agalsidase beta) with revised temporary treatment recommendations

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