Newly approved medicinal products
23.09.2009
Here you can find a list of newly approved medicinal products between 1st August 2009 and 31st August 2009.
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23.09.2009
Here you can find a list of newly approved medicinal products between 1st August 2009 and 31st August 2009.
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26.08.2009
Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2008 was published by the Agency for Medicinal Products and Medical Devices on its website on 26 August 2008.
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24.08.2009
Here you can find a list of newly approved medicinal products between 1st July 2009 and 31st 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authorisation of the finished medicinal product Raptiva 100 mg/ml (efalizumab) in the Republic of Croatia, has been withdrawn in accordance with the European Medicines Agency recommendation and the decision by the European Commission.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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08.07.2009
Here you can find a list of newly approved medicinal products between 1st June 2009 and 30th June 2009.
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07.07.2009
Here you can find a list of newly approved medicinal products between 1st May 2009 and 31st May 2009.
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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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