With regard to the decisions of the Chief Pharmaceutical Inspector, on 21 August 2018 the Board of the Celon Pharma S.A. announces that the decisions had been issued at the Company's request. The undertaken actions constitute a response to a global market situation regarding the active ingredient valsartan.. These steps are preventive in nature and are taken due to a suspicion that the active ingredient valsartan may not be meeting its specification.
In relation to actions conducted at the European and Polish level in order to confirm the safety of the active ingredient valsartan originating from different suppliers, Celon Pharma S.A. has been in touch with regulators, providing them with information on the quality aspects of the active ingredient used in Valzek as well as on the medicine itself, ever since the occurrence of the first market problem with this API.
The data provided to regulators indicate that the level of contamination with N-nitrosodimethylamine (NDMA) in a medicine containing valsartan remains well below the norms recognised by the EMA and the FDA as safe and administration of Valzek does not constitute a risk to a patient's life and health.
However, in order to address this difficult and unprecedented market situation, where the safety of the patients is the utmost priority, the Management Board decided to apply to the Chief Pharmaceutical Inspector for temporary withholding of the circulation of Valzek which contains the active ingredient valsartan originating from Zhejiang Tianyu Pharmaceuticals, a supplier, until the European and Polish regulators have resolved the issue in full.
Due to the ensuing situation, the Company has launched a helpline: 519 066 531, where patients can obtain information about the product batches withheld from circulation.
In the Management Board's opinion, the situations in question is temporary. After all quality aspects related to the active ingredient we use have been confirmed, the Company, in consultation with the regulator, will endeavour to place the withheld batch back on the market.
Furthermore, the Management Board remains at full disposal of the regulators and declares further cooperation with them in order to resolve the ensuing situation as soon as possible and mitigate its effects for patients and healthcare providers.