News on Safe Use of Medicinal Products - For Patients

The recall of three batches of the medicinal product Glibenclamid Genericon 3,5 mg tablets

20.11.2012

Genericon Pharma, d.o.o., the marketing authorisation holder for the medicinal product Glibenclamid Genericon 3,5 mg tablets, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about its decision to recall three batches (10A014, 10A16A and 10A16 B) of the medicinal product Glibenclamid Genericon 3,5 mg tablets, blister pack of 120 tablets, from the Croatian market.
The decision about the recall was taken after the analysis discovering a slight increase of the acidic acid content, alkyl esters of fatty acids and olefins. Even though toxic components have not been determined, it was decided to recall all the three batches affected by the aforementioned quality defect. The marketing authorisation holder has informed all Croatian distributers about the recall.

Information about the expected shortage of the medicinal product Tienam powder for solution for infusion (imipinem, cilastatin)

20.11.2012

Merck Sharp & Dohme d.o.o., the marketing authorisation holder for medicinal product Tienam, powder for solution for infusion (imipenem, cilastatin) has informed the Agency for medicinal products and medical devices (HALMED) about the expected shortage of the aforementioned product.
The shortage is due to certain difficulties in the manufacturing process and it is expected to last up to several months. Currently available product batches will be distributed on the Croatian market until they are out of stock.
There are other products from the same chemical-therapeutic subgroup currently available on the Croatian market.

Dear Pharmacist letter with instructions for dispensing one batch of the medicinal product Betazon 0,5 mg/g ointment

04.10.2012

The company “Jadran” - Galenski laboratorij d.d. (JGL), which is the marketing authorisation holder for Betazon 0,5 mg/g ointment, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to pharmacists with instructions for dispensing the batch 2162 of the aforementioned medicine due to the discovered print defect on the outer packaging of the single pack unit. You may view the text of the letter in the continuation of this information.

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.