Preparations with active ingredient valsartan respond from the market. During press conferences in Service central communications reported about it the chairman of Committee of pharmacy of MZ RK Byurabekova Ludmila, the acting as the chairman of the board Limited liability partnership "SK-Farmatsiya" Berik Sharip, the first deputy director generals the National center of examination of medicines Nurtaev Arnur and the medical director of the representative of the producer of Ratiopharm Kazakhstan LLP Smailov Zayr.
by words Byurabekova Ludmila, the European agency on medicines (EMA), Management on sanitary supervision of quality of food products and medicines of United States of America (FDA) withdraws from the markets preparations with active ingredient valsartan which active substance is made by the Chinese company Province of Zhejiang Huahai Farmasyyutikals which is based in the province of Linghai (China). The response reason – availability of dangerous impurity in preparations in some parties of active substance. "Preparations with active ingredient valsartan are applied at patients with high arterial pressure" , - the chairman of committee of pharmacy of MZ RK noted.
the Response was initiated byafter N-nitrozodimetilamina (NDMA) detection in an active farmsubstantion which the Chinese company delivers to producers valsartana. NDMA is classified as probable carcinogen of the person. Its existence in the valsartena as believe, is connected with changes in a way of production active agent.
EMA, FDAnow carry out an assessment of the NDMA level and potential impact on the patients accepting a preparation. At emergence of new information, it will be published at once on sites of regulators.
the First deputy director generals the National center of examination of medicines reported that according to the State register of medicines, active pharmaceutical substance valsartana productions Province of Zhejiang Huahai Farmasyyutikals, is included in registration certificates of the following preparations:
1) "Nortivan" , the tablets covered with a film cover of 40 mg, 80 mg, 160 mg of productions Gedeon Richter Plc;
2) "Vazar" tablets of 40 mg, 80 mg, 160 mg and Vazar-N of a tablet 80/12,5mg, 160/12,5 mg, 160/25 mg, productions Balkanpharma Dupnica AD, entering holding Teva – in Kazakhstan is presented to Ratiopharm Kazakhstan LLP;
3) of "Kombi Kardofiks-sanovel Plus" tablets of 5/160/12,5 mg, 5/160/25 mg, 10/160/12,5 mg, 10/160/25 mg of productions Pharmako-industrialnaya trade company "Sanovel", Turkey.
Producers of medicines, containing valsartan, received the notice from companies, making raw materials for active ingredient of this preparation, about possible unsatisfactory quality of these raw materials.
on the basis of the letter from representation of Gedeon Richter Plc the order of the Chairman of Committee of pharmacy of Ministry health care of Republic of Kazakhstan withdrew on July 10, 2018 a number of series (parties) medicines "Nortivan" in the tablets covered with a film cover of 40 mg, 80 mg, 160 mg.
the Company Pharmako-industrialnaya trade company "Sanovel" from the moment of registration did not import the preparation on RK territory.
during made internal investigation by Committee of pharmacy of MZ RK made the decision on a response of the registration certificate of the preparation "Vazar".
As preparations are used byin treatment of serious diseases, it is not necessary to stop reception of the withdrawn preparations without permission of the treating doctor. In this regard to all patients accepting valsartan specified producers, it is necessary to address immediately to the doctor for replacement by other preparation.
according to the acting as the chairman of the board Limited liability partnership "SK-Farmatsiya" Berik Sharip, the preparation "Vazar" of productions "The Balkans farma" is bought Limited liability partnership "SK-Farmatsiya" within GOBMP for free out-patient holiday. In connection with current situation, the uniform distributor made the decision on a preparation response to the end user, and replacement released in 2018 according to the free recipe within GOBMP of medicines according to the instruction of the attending physician.
remains of the preparation "Vazar" Available on hands tablet of 80 mg. with serial numbers 471217, 471317, 301717, 333217, 209917, 419817, 419917, 420017, 488117 it is necessary to hand over in that drugstore or the medical organization where it was released according to the free recipe. Withdrawn series of preparations will be transferred in the subsequent by the uniform distributor to representatives of the producer.
"At the same time the preparation with active ingredient valsartan with a dosage of 160 mg is bought byunder the trade name "Valsakor", by production which substance of other producer was applied. The preparation is available in warehouses of the uniform distributor in number of more than 4 million tablets. In need of replacement the uniform distributor is ready to provide patients with other preparations" , - Berik Sharip noted.
according to medical the director of Ratiopharm Kazakhstan LLP Zayra Smailova, the producer "The Balkans farma" assumes obligations for tracking of the patients accepting their preparation of productions.
"To the patients accepting the withdrawn preparation, in case of the undesirable phenomena it is necessary to address to the attending physician who will report further about the revealed influences connected with application of a preparation to the producer. Also they can report about such phenomena in representation of the producer in Kazakhstan, in Ratiopharm Kazakhstan LLP by phone 8 (727) 325 1615" , - reported Smailov Zayr. Thus the representative of the producer noted that threat of immediate harm for patients from application of a preparation is absent.