News and Educations

Information about the temporary suspension of distribution and use of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion

10.09.2013

The Agency for Medicinal Product and Medical Devices (HALMED) has completed the special quality control of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion.
We remind that the marketing authorisation holder, Sandoz d.o.o., upon HALMED’s request initiated a temporary suspension od distribution and use of the batch CU2047 of the aforementioned medicinal product due to reports to suspected product quality that was posted on HALMED’s web site on 17 June 2013.
With regard to the aforementioned, the temporary suspension of distribution of the batch CU2047 of the medicinal product Lendacin 1 g powder for solution for injection/infusion is abolished and the product may be distributed and used.

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Dear Health Care professional letter about the importance of careful use of medicinal products Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban)

05.09.2013

The marketing authorisation holders for medicinal products Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) have, in collaboration with the European Meidines Agency (EMA) and Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals with the aim to remind them about the careful use of these medicines.
Clinical trials and the post-marketing experience have demonstrated that the occurrence of major bleeding, including the events that led to death are not limited only to vitamin K antagonists and low-molecular weight heparins, but represent important risks associated with the use of these new anticoagulants. Furthermore, spontaneous reporting of adverse reactions to these medicines indicate that prescribers are not well informed about these medicines with regard to bleeding risk management.

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The Workshop: “ICH Endorsed Pharmacovigilance”

30.08.2013

The Agency for Medicinal Products and Medical Devices (HALMED) and the Drug Information Association (DIA) are organising a workshop on ICH standards for pharmacovigilance (E2) entitled “ICH Endorsed Pharmacovigilance”. The workshop will be held on 28 and 29 November 2013, at HALMED’s premises, Robert Frangeš Mihanović Street 9 (Sky Office Building).
The workshop will include topics related to pharmacovigilance standards impleneted in a pre- and post-authorisation phase and the implementation of ICH guidelines in an international environment. The workshop includes also case studies and examples from practice.

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Dear Healthcare Professional Letter on the association of clopidogrel (medicinal products Plavix 75 mg and 300 mg film coated tablets and Duoplavin 75 mg/75 mg and 75/100 mg film-coated tablets) with acquired haemophilia

26.08.2013

sanofi-aventis Croatia d.o.o., the representative of the marketing authorisation holder Sanofi Pharma Bristol-Myers Squibb SNC in the Republic of Croatia for medicinal products Plavix 75 mg and 300 mg film-coated tablets and Duoplavin 75mg/75mg and 75 mg/100 mg film coated tablets, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about an important information related to the use of clopidogrel.
The letter informs healthcare professionals about the new and special warnings and cautionary measures related to the use of those medicines due to their association with the acquired haemophilia.

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Information about the shortage of the medicinal product Diamox 250 mg tablets (acetazolamide)

22.08.2013

Medical Intertrade d.o.o., the marketing authorisation holder for the medicinal product Diamox 250 mg tablets (acetazolamide) has informed the Agency for Medicinal Products and Medical Devices about the shortage of the aforementioned medicine on the Croatian market. The shortage is due to manufacturing problems.

The normalisation of the supply chain with that medicine is expected in January 2014. During that period the medicinal product for the treatment of Croatian patients will be provided under the legal exemption scheme for products that are not authorised in Croatia.

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3rd Workshop on medicines regulatory affairs

21.08.2013

Following the announcement about one day workshops on medicines regulatory affairs, organised by the Agency for Medicinal Products and Medical Devices, we inform all interested that the third workshop will be held on Friday, 25 October 2013 at 9 a.m. (the approximate duration until 4 p.m.) at HALMED’s premises , Robert Frangeš Mihanović Street 9 (Sky Business office), 1st Floor, 10000 Zagreb. The first workshop will be held on Friday, 27 September 2013, from 9 to 16 h.

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Dear Healthcare Professionals letter about the restriction of the use of the medicinal product Trobalt (retigabine) due to the risk of discolouration of eye tissues including retina, skin, lips and/or fingernails

19.08.2013

Glaxo Smith Kline d.o.o., the marketing authorisation holder for the medicinal product Trobalt (retigabine) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) issued a letter to healthcare professionals about the restriction of indications for the medicinal product due to a risk of discolouration of eye tissues, including retina, skin, lips and/or nailfingers.

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