By way of decisions of the Chief Pharmaceutical Inspectorate of 6/06/2019, the following drug batches mentioned therein – Valzek 80mg and Valzek 160mg – were re-approved for marketing, as a result of confirming their compliance with quality requirements for the applicable substance valsartan, determined by the regulators. Based on these decisions, batches of Valzek marked with numbers listed in the aforementioned decisions can be administered to patients and sold by pharmacies in line with the current market availability.
Decisions on re-approving the listed product batches for marketing:
By way of separate decisions of the Chief Pharmaceutical Inspectorate of 6/06/2019, the following drug batches mentioned therein – Valzek 80 mg and Valzek 160 mg – were withdrawn from the market for slightly exceeding the level of NDMA (nitrosodimethylamine) impurities determined by the regulators with regard to valsartan. This situation in no way puts the patients’ health and lives at risk. Patients in possession of Valzek marked with the numbers listed in the aforementioned decisions may return the drug to the pharmacy where it was purchased. The pharmacies will provide the patients with all information on the procedure of returning a drug belonging to a batch covered by the decision of the Chief Pharmaceutical Inspectorate.
Decisions on withdrawing the listed product batches from the market: