News and Educations

Review about the known risks of an abnormal heart rhythm regarding the use of azithromycin and other macrolide antibiotics

18.05.2012

HALMED is aware of the results of the study published in the New England Journal of Medicine, on May 17, 2012, that compared the risks of cardiovascular death in patients treated with various antibiotics, including azithromycin. Results of the study are expected, given that azithromycin, as the only medicine from the macrolide antibiotic class was compared with antibiotics from other classes. It has been previously known for macrolide antibiotics that they are associated with a serious abnormalities of the heart rhythm, which occure rarely and due to the high effectiveness of these medicines, the benefit risk ratio of their use remains positive.

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Information on the expected shortage of the medicinal product ImmuCyst 81 mg powder for suspension for intravesicular use, BCG for immunotherapy

17.05.2012

Medoka d.o.o., the marketing authorisation holder for the medicinal product ImmuCyst 81 mg powder for suspension for intravesicular use, BCG for immunotherapy has notified the Agency for Medicinal Products and Medical Devices about the expected shortage of this medicine on the Croatian market. The product manufacturer, Sanofi Pasteur Limited (Toronto, Canada) has temporarily disrupted the supply of the product Immucyst, due to which a global shortage is expected.

The available dosages of the medicinal product ImmuCyst in Croatia are not affected by the aforementioned disruption. The marketing authorisation holder will inform about the expected shortage all the healthcare facilities where the product is used.

The public will be informed in due time about every new information on the availability of the product.

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Information about the expected shortage of the medicinal product Androgel 50 mg, gel in unit-dose sachet

11.05.2012

The marketing authorisation holder for Androgel 50 mg, gel in unit-dose sachet, Abbott laboratories d.o.o., has informed the Agency for Medicinal Products and Medical Devices on the expected shortage of the medicinal product Androgel 50 mg, gel in unit-dose sachet (testosterone) on the Croatian market. The origin of the shortage is the termination of the Contract with the manufacturer Besins Manufacturing Belgium, Drogenbos, Belgium.

Untill the normalisation of supply of the Croatian market with the medicinal product Androgen, the Agency for Medicinal Products and Medical Devices will authorise the import of the product under the legal exemption scheme for patients need.

HALMED will make publicly available any new information on the availability of the medicinal product Androgen in due time.

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New column launch: CROATIAN ACCESSION TO THE EUROPEAN UNION – guidelines for marketing authorisation holders

08.05.2012

The Agency for Medicinal Products and Medical Devices (HALMED) has launched a new column named „CROATIAN ACCESSION TO THE EUROPEAN UNION“ – guidelines for marketing authorisation holders, which will be making publicly available useful guidelines to marketing authorisation holders relating to harmonisation of marketing authorisation procedures, what awaits us with the accession of Croatia to the EU. The answers that are being posted on this website, HALMED has received from the European Commission, European Medicines Agency and Heads of Medicines Agencies (HMA) intergovernmental network.

The column will be regularly updated and supplemented with new informations encompassing all the marketing authorisation procedures for medicinal products.

The first text that is published in this column refers to centrally authorised medicinal products.

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Information to marketing authorisation holders about the beginning of the using of of the new list of serious adverse reactions

08.05.2012

The Agency of Medicinal products and Medical Devices (HALMED) started from May 8, 2011 using the new version of the list of serious adverse drug reactions (ADRs) for coding of ADRs and posted it on its web site. The list of serious ADRs has been updated and harmonised with the newest version of the IME (Important medical events) list. The new version of the IME list that is based on the version of the 15.0 MedDRA dictionary, was published in March this year.

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Dear Pharmacist Letter on reduction of the shelf-life of Athyrazol medicinal product from five to one year and measures with regard to dispensing and returning of medicinal product older than one year

03.05.2012

The „Jadran“ – Galenski laboratorij d.d. Company, the marketing authorisation holder of Athyrazol, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED), has sent out a letter to pharmacists informing them about the recall for precautions of Athyrazol batches older than one year.

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The shelf-life of Athyrazol is being reduced from five to one year for precautions, batches older than one year are being recalled from the market

02.05.2012

The shelf-life of Athyrazol is being reduced from five year to one year and batches older than one year are for precautions being recalled from the Croatian market. During the continuous monitoring of the product quality, a stability testing was carried out, which indicated the presence of a higher content of degradation products with respect to the product specification.

Due to the afore mentioned, the Agency for Medicinal Products and Medical Devices (HALMED) and JGL d.d., the marketing authorisation holder for Athyrazol have carried out a toxicologic evaluation and risk assessment for patients, after which HALMED has concluded that the content of the afore mentioned degradation products do not present a toxicological risk for patients. However, for precautions, the shelf-life of Athyrazol is being reduced from five to one year and batches older than one year are being withrawn from the market.

Agency for Medicinal Products and Medical Devices (HALMED) for precautions , recommends that patients having Athyrazol tablets at home verify whether their batch number and the shelf-life correspond to the following list and if so, return them to their pharmacy. The list of Athyrazol tablets older than one year, mentioned in the form: batch number (shelf-life): 6187 (12/2012), 61872 (12/2012), 06182 (03/2013), 1868 (07/2013), 2788 (10/2013), 01092 (01/2014), 0319 (02/2014), 0109 (01/2014), 08193 (04/2014), 1059 (05/2014), 1699 (08/2014), 2309 (11/2014), 03702 (02/2015), 09502 (04/2015), 09503 (04/2015), 1400 (05/2015), 3270 (12/2015), 0211 (02/2016), 02012 (02/2016), 0931 (03/2016), 0941 (03/2016), 2951 (07/2014).

HALMED and JGL have informed pharmacists about the reduction of the shelf-life of Athyrazol medicinal product and about the recall for precautions of batches older than one year and instructed them to inform patients about it.

HALMED has not received any ADR report for Athyrazol tablets that would indicate a harmful effect of the higher than specified degradation products content. All batches of Athyrazol tablets having the new shelf-life that will remain on the Croatian market and will be accessible to patients, completely fulfill the criteria of quality, safety and efficacy.

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Volontary withrawal of certain batches of the medical device IMAGER II angiographic catheter

26.04.2012

Medical Intertrade d.o.o., the registration holder of this medical device in Croatia, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the volontary withrawal of certain batches of medical devices IMAGER II angiographic catheter, manufactured by Boston Scientific Corporation, USA, due to a detected quality defects in certain product batches.

Boston Scientific Corporation, USA, the manufacturer , has received reclamations about defective packagings, resulted from physical interactions between the carton on the pouch where the hub is located which may cause contamination of the product. Therefore, the manufacturer has taken precautions measures and decided to withraw all the affected batches.

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