Pharmacovigilance

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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Dear Health Care Professionals letter on new contraindications and revised warnings for medicinal products containing the active substance strontium ranelate (Osseor/Protelos)

06.04.2012

Servier Pharma d.o.o. company which is the marketing authorisation holder for finished medicinal products Osseor 2 g granules for oral suspension and Protelos 2 g granules for oral suspension, has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals on new contraiondications and revised warnings for medicinal products containing the active substance strontium ranelate.

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Information on preventive recall of certain batches of the solution for organ transfusion ViaSpan due to a contamination risk

30.03.2012

The supplier of the ViaSpan solution for organ perfusion, PharmaSwiss d.o.o. Company has informed on the March 30th 2012 the Agency for medicinal products and medical devices (HALMED) on the initiation of a preventive racall of all the solutions for organ perfusion ViaSpan, manufactured as of July 2011 due to a doubt about a quality defect and a possible contamination risk.

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"Dear Healthcare Professional Letter" on volontary recall of certain batches of the medicinal product Carboplatin Ebewe

30.03.2012

The marketing authorisation holder for the Carboplatin Ebewe medicinal product, Wϋrth d.o.o. Company, in collaboration with the Croatian Agency for medicinal Products and medical Devices (HALMED), has sent a "Dear Healthcare Professional Letter" on recall of certain batches of the Carboplatin Ebewe medicine. HALMED has affirmed that a replacement therapy for patients on the Croatian market exists.

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"Dear Doctor Letter" on spotted error in the package information leaflet for M-M-RVAXPRO vaccin

23.03.2012

Merck Sharp & Dohme d.o.o. Company, which is the marketing authorisation holder for M-M-RVAXPRO medicinal product, has sent a "Dear Doctor Letter" in collaboration with the Croatian Agency for Medicinal Products and Medical Devices on the spotted error in the patient information leaflet. The text incorrectly rendered "in subcutaneous muscle" as the route of administration instead of the correct text "intramuscular or subcutaneous application."

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