Medicinal Products

PRAC confirms that hydroxyethil-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients

11.10.2013

The European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has completed the review of hydroxyethil-starch-containing (HES) solutions following an assessment of new information and commitments for additional studies and risk minimisation activities. The PRAC confirmed that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients, because of an increased risk of kidney injury and mortality. HES solutions may, however, continue to be used in patients to treat hypovolaemia (low blood volume) cause by acute blood loss, provided that appropriate measures are taken to reduce potential risks and that additional studies are carried out.
You may find more detailed information under the following link:

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European Medicines Agency begins to publish recommendations based on safety signals

07.10.2013

The European Medicines Agency (EMA) has published the first overview listing the recommendations stemming from the assessment of safety signals by the Pharmacovigilance Risk Assessment Committee (PRAC). The document covers all safety signals discussed during the September 2013 PRAC meeting and the recommendations given for each of them. It includes PRAC recommendations for centrally and nationally authorised medicines.
The evaluation of safety signals by the PRAC has been implemented with the new pharmacovigilance legislation. A cumulative list of all signals discussed at the PRAC since September 2012 available on the EMA web pages or under the following link.

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Dear Healthcare Professional Letter about the risk of appearance of an intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients treated with risperidone or paliperidone

05.10.2013

Janssen-Cilag International NV and Johnson & Johnson S.E. d.o.o., the marketing authorisation holders in the Republic of Croatia for medicinal products Xeplion 25 mg, 50 mg, 75 mg, 100 mg suspension for injection with prolonged release (paliperidone), Invega 1,5 mg, 3 mg, 6 mg, 12 mg tablets with prolonged release (paliperidone), Rispolept Consta 25 mg, 37,5 mg, 100 mg powder and solvent for suspension for injection with prolonged release for intramuscular application (risperidone), Rispolept 1 mg, 2 mg, 3 mg, 4 mg film-coated tablets (risperidone) and Rispolept 1 mg/ml solution for oral use (risperidone), have, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about the risk of appearance of an intraoperative floppy iris syndrome during cataract surgery in patients treated with risperidone paliperidone.

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Information about the temporary distribution of Partusisten 5 mg tablets

01.10.2013

Boehringer Ingelheim Zagreb d.o.o. , the marketing authorisation holder for Partusisten 5 mg tablets (fenoterol) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to temporary interrupt the distribution of the medicinal product as a precaution measure until the outcome of the arbitration procedure in the course in the EU for short-acting beta agonists in obstetric indications, due to findings that indicate an insufficient efficacy of oral forms of these medicines.

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Information about the temporary suspension of distribution and use of three batches of Manit 10%

12.09.2013

The Agency for Medicinal Products and Medical devices has carried out a special quality control of the baches 2004032, 2004072 and 2050102 of Manit 10%.
We remind that on the 10th April 2013, HALMED informed about the initiation of the suspension of distribution and use of the batches 2004032, 2004072 and 2050102 of Manit 10%, upon a report from a healthcare professional to a suspected adverse reaction to trombolflebitis on the application site of manitol 10% in six patients.

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Start of a new HALMED’s campaign on promoting the importance of package leaflet reading and reporting of ADRs

11.09.2013

The Agency for Medicinal Products and Medical Devices (HALMED) has started a public education campaign aimed at promoting the importance of package leaflet reading and ADR reporting among patients and end consumers. The aim of the campaign is to inform citizens that, alongside the information provided by a qualified healthcare professional, additional information may be obtained through package leaflet reading and to motivate them to get actively involved in the medication and monitoring of safe use of medicines by reporting ADRs. This approach will further contribute to the improvement of the safe use of medicines and more efficient health care for patients and overall public health.
The campaign will intensively be carried out at the national level from the beginning of September to the end of October this year through billboard, press ads, radio spots, on-line banners, posters in doctors’ waiting rooms and information leaflets on ADRs reporting that will be available in pharmacies throughout the country.

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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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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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