Pharmacovigilance

A Dear Healthcare Professional letter to physicians about the restricted supply of the medicinal product Fabrazyme (agalsidase beta)

26.02.2010

The marketing authorisation holder in the Republic of Croatia for Genezyme Corporation's medicinal products, Medical Intertrade d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices sent a Dear Healthcare Professional letter to prescribing physicians about the future restricted supply of Fabrazyme (agalsidase beta). The revised provisional treatment recommendations published in September 2009 are still valid.

Genzyme informs that decreased supply will continue until the end of June 2010. Prescribing physicians are further advised to adhere to the provisional treatment recommendations published in September 2009. The prescribing physicians are hereby warned about the need for close clinical surveillance of all patients, particularly those on the low-dose therapy.

The text of the letter is available below:
"Information for physicians concerning further restrictions in the supply of the medicinal product Fabrazyme (agalsidase beta) and update on the supply"

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