05.10.2009
U.S. Food and Drug Administration (FDA) issued a press release informing the public about the reports of cases of acute pancreatitis in patients receiving the medicinal products containing sitagliptine as the active ingredient.
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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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14.08.2009
Genzyme Corporation informed the European Medicines Agency (EMEA) that the supply shortage of the medicinal products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) would be more severe than initially expected. Consequently, EMEA's Committee for Medicinal Products for Human Use (CHMP) updated its temporary treatment recommendations.
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06.08.2009
Following the News issued by the Agency for Medicinal Products and Medical Devices on February 2009, the marketing authorisation of the finished medicinal product Raptiva 100 mg/ml (efalizumab) in the Republic of Croatia, has been withdrawn in accordance with the European Medicines Agency recommendation and the decision by the European Commission.
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24.07.2009
Following review of all available information on a possible relationship between insulin analogues, in particular insulin glargine; and the risk of cancer, European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary.
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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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06.07.2009
Novartis Hrvatska d.o.o., in cooperation with the Agency for Medicinal Products and Medical Devices, on 6 July 2009, sent a Dear Healthcare Professional Letter to prescribing physicians in order to inform them about the latest data on safe use of Myfortic 360 mg film-coated gastro-resistant tablets (mycophenolic acid).
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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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30.06.2009
The European Medicines Agency (EMEA) issued a press release concerning the safety of the medicinal products containing insulin glargine as active substance, in connection with the recently published registry studies investigating a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer.
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24.06.2009
On 24 June 2009, in cooperation with the Agency for Medicinal Products and Medical Devices, Roche d.o.o. sent a Dear Healthcare Professional Letter to prescribing physicians concerning implementation of the pregnancy risk reduction measures during use of CellCept (mofetilmycophenolate).
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