Dear Healthcare Professional Letter to physicians concerning the supply shortage of medicinal products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) and consequent temporary treatment recommendations
01.07.2009
Medical Intertrade d.o.o., the marketing authorisation holder of the Genzyme medicinal products in the Republic of Croatia, in cooperation with the Agency for Medicinal Products and Medical Devices, sent a Dear Healthcare Professional Letter to prescribing physicians concerning the supply shortage of medicinal products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) and consequent temporary treatment recommendations.
The marketing authorisation holder in the Republic of Croatia, together with the manufacturer, informed the Agency of the temporary supply shortage of these medicinal products, which is expected to be resolved by the end of the year. The supply shortage is caused by the shutting down the Cerezyme and Fabrazyme manufacturing facility because one of the bioreactors was affected by a low degree of a virus which impairs cell growth of the imiglucerase-producing cells (active substance of Cerezyme). Therefore, the European Medicines Agency released a public statement announcing a temporary supply shortage of Cerezyme and Fabrazyme in the European Union. In its statement, the EMEA states that the identified virus is not known to cause disease in humans, but it may affect the quantity, but not the quality of the enzymes produced in the bioreactors.
To ensure that existing stocks last as long as possible until new batches can be produced, the European Medicines Agency (EMEA) has agreed to some temporary changes to the way these medicines are prescribed for treatment of patients with Gaucher or Fabry disease. These changes should be implemented immediately in order to prevent possible interruptions of treatment.
The Agency for Medicinal Products and Medical Devices of the Republic of Croatia stresses that temporary measures do not change the currently approved Product Information for either Cerezyme or Fabrazyme.
The full text of the letter can be found below:
"Information to physicians concerning the supply of medicinal products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) and provisional treatment recommendations"
