Newly approved medicinal products
08.06.2009
Here you can find a list of newly approved medicinal products between 1st April 2009 and 30th April 2009.
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News and Educations
Safe use of thionamide class of medicinal products
05.06.2009
The U.S. Food and Drug Administration (FDA) reported on the new data indicating increased hepatotoxicity associated with the medicinal products containing propilthiouracile as active substance. It should be emphasised that no conclusion has been reached regarding the cause-effect relationship and that the FDA's information ought not to be interpreted as a recommendation to discontinue the treatment with propilthiouracile.
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Potential interaction between clopidogrel and proton pump inhibitors
05.06.2009
The European Medicines Agency (EMEA) published a statement on potential interaction between clopidogrel and proton pump inhibitors. In patients simultaneously taking clopidogrel and a proton pump inhibitor, the effect of clopidogrel may be reduced, which may result in an increased risk of, for instance, heart attack and cerebral thrombosis, or the coronary stent and bypass thrombosis.
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Dear Healthcare Professional Letter on new information regarding the safety of Tarceva (erlotinib)
25.05.2009
In cooperation with the Agency for Medicinal Products and Medical Devices, on 25 May 2009, Roche d.o.o. sent a Dear Healthcare Professional Letter to prescribing physicians regarding the new information on safety of Tarceva film tablets (erlotinib).
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Safe use of antiepileptic medicines
06.05.2009
The U.S. Food and Drug Administration (FDA) announced the end of a review of a group of antiepileptic medicines and recommendations regarding the safety of their use.
The Agency for Medicinal Products and Medical Devices of the Republic of Croatia will approve amendments to the medicinal product information (Summary of Product Characteristics, Patient Leaflet) for the above group of medicines and continue to closely monitor the safety of this group of medicinal products.
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The Agency at the 37th International Medicine and Technology Fair
06.05.2009
The 37th International Medicine and Technology Fair, traditionally under the auspices of the Croatian Ministry of the Health and Social Welfare, has been opened on 6 May 2009 at the Zagreb Fair grounds.
The Agency for Medicinal Products and Medical Devices, also an exhibitor at the Fair, invites you to visit us at Pavilion 6, Stand 15a
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Advanced reservations by phone for submission of documents to the Agency's Registry
05.05.2009
Starting 5 May 2009, it will be possible to make an advanced reservation by phone for submission of documents to the Registry of the Agency for Medicinal Products and Medical Devices. The reservations can be made between 8.00 a.m. and 2.00 p.m. each working day at the following phone number: 4884 162. Those with advanced reservations will be received at the Registry from 8.00 to 9.00 a.m. on all working days. All other clients will be received on all working days, from 9.00 a.m. until 2 p.m.
Clients with a large number of documents to be submitted to the Registry are kindly advised to make use of the advanced phone reservation system in order to obtain an appointment slot.
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The Agency approves the future use of the Augmentin injection 1.2 g packaging with 5 vials/box series withdrawn for precautionary reasons
05.05.2009
Having confirmed the adequate quality of the Augmentin injection 1.2 g packaging with 5 vials/box series no. 392761, of the marketing authorisation holder GlaxoSmithKline d.o.o., Zagreb, previously withdrawn for precautionary reasons, the Agency approved its future use and marketing.
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Newly approved medicinal products
23.04.2009
Here you can find a list of the newly approved medicinal products between 1st March 2009 and 31th March 2009.
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Newly approved medicinal products
22.04.2009
Here you can find a list of the newly approved medicinal products between 1st February 2009 and 28th February 2009.
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