The Main Pharmaceutical Inspector withdrew from sale a series of medicinal products containing the active substance valsartanum, produced by the Chinese manufacturer. Hence, significant contamination was detected. The GIF decision is the result of a recommendation from the European Medicines Agency.
The European Medicines Agency, together with EU Member States, is currently evaluating the health effects of the use of products containing contaminated valsartanum. GIF announced that “as a preventive measure, out of concern for the safety of Polish patients”, the Main Pharmaceutical Inspector decided to withdraw from the market medicinal products containing valsartanum, supplied by the Chinese manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd.
Medicinal products containing valsartan are used to treat high blood pressure. National consultant in the field of cardiology prof. Jarosław Kaźmierczak recommends that patients who have been treated with products containing this active substance, contact their attending physician (primary care physician or specialist), who will replace valsartan with another drug from the same group of sartans (e.g. losartan, candesartan, telmisartan, irbesartan, eprosartan) or will use a drug / group of drugs with a similar therapeutic effect, i.e. angiotensin-converting enzyme inhibitors or other antihypertensive drugs.
All decisions on withdrawing medicinal products from the market are published on the website of the Main Pharmaceutical Inspectorate in the “Decisions and notices” tab.
Full list of drugs for hypertension withdrawn from sale:
1. Avasart 80 mg
2. Avasart 160 mg
3. Avasart Plus (Amlodipine + Valsartan), 5 mg + 80 mg
4. Avasart Plus (Amlodipine + Valsartan), 5 mg + 160 mg
5. Avasart Plus (Amlodipine + Valsartan), 10 mg + 160 mg
6. Awalone 80 mg
7. Awalone 160 mg
8. They help 80 mg
9. They help 160 mg
10. They help 320 mg
11. Help HCT 80 mg + 12,5 mg
12. Help HCT 160 mg + 12,5 mg
13. Help HCT 160 mg + 25 mg
14. Help HCT 320 mg + 12,5 mg
15. Help HCT 320 mg + 25 mg
16. Co-Nortivan (Valsartanum + Hydrochlorothiazidum), 80 mg + 12,5 mg
17. Co-Nortivan (Valsartanum + Hydrochlorothiazidum), 160 mg + 12,5 mg
18. Co-Nortivan (Valsartanum + Hydrochlorothiazidum), 160 mg + 25 mg
19. Ivisart 160 mg
20. Ivisart 80 mg
21. Nortivan Neo 80 mg
22. Nortivan Neo 160 mg
23. Tensart 80 mg
24. Tensart 160 mg
25. Tensart HCT 160 mg + 12,5 mg
26. Tensart HCT 160 mg + 25 mg
27. Valorion 160 mg
28. Valorion 80 mg
29. Valtap 160 mg
30. Valtap 80 mg
31. Valtap HCT 160 mg + 12,5 mg
32. Valtap HCT 160 mg + 25 mg
33. Vanatex 80 mg
34. Vanatex 160mg
35. Vanatex HCT (Valsartanum + Hydrochlorothiazidum), 80 mg + 12,5 mg
36. Vanatex HCT (Valsartanum + Hydrochlorothiazidum), 160 mg + 12,5 mg
37. Vanatex HCT (Valsartanum + Hydrochlorothiazidum), 160 mg + 25 mg
38. Valsotens HCT (Valsartanum + Hydrochlorothiazidum)160 mg + 25 mg
39. Valsotens HCT (Valsartanum + Hydrochlorothiazidum), 160 mg + 12,5 mg
40. Valsotens 160 mg