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.

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Extension of shelf life for Tamiflu 75 mg, 45 mg and 30 mg hard capsules

17.07.2009

The European Medicines Agency (EMEA) has recommended that the shelf life of Tamiflu capsules should be extended from 5 to 7 years. The Agency for Medicinal Products and Medical Devices approved this variation for all dosages of the Tamiflu hard capsules that have the marketing authorisation in the Republic of Croatia (Tamiflu 75 mg, 45 mg and 30 mg). The Summary of Product Characteristics, Medicinal Product Labelling and Patient Information Leaflet in all newly manufactured capsule series will be amended accordingly.

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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.

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