Shorter expiry date of Athyrazol

The expiry date of Athyrazol is shortened from five to one year and all series of the drug older than one year will be withdrawn from the Croatian market for preventive purposes. The stability of the drug was tested during continuous monitoring of its quality, which has indicated presence of a larger content of degradation products of active substances than allowed by the specification of the drug. In light of this the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and JGL d.d., holder of the approval of Athyrazol, have conducted toxicological evaluation and risk assessment for patients, after which HALMED found that the content of these degradation products does not pose a toxicological risk to patients. However, for preventive purposes the period of validity of Athyrazol is shortened from five to one year and series older than one year will be withdrawn from the market.

For preventive reasons HALMED advises patients to check the control number and expiry date of Athyrazol tablets they have at home and return the medicine to the pharmacy if it is featured on the list of series of drugs older than one year.

List of series of Athyrazol older than one year, specified in the form: control number (expiry date):

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 notified pharmacists of shortening the expiry period of Athyrazol and the preventive withdrawing of series older than one year and have instructed them to inform patient thereof.

HALMED has not received any reports on side effects of Athyrazol that would indicate a harmful effect of the content of degradation products larger than specified.

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