The Executive Agency for Drug Control and Addiction stopped 62 drugs due to an alleged carcinogen (OBZOR)

Sofia. The Medicines Agency (BDA) blocks 62 pharmaceuticals for the treatment of hypertension, heart attacks and heart failure due to a probable carcinogen problem. This emerges from a message published on the site of BDA . He indicates that the European Medicines Agency (EMA) and the relevant national authorities have been informed of the presence of an impurity in the active substance valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China. The impurity N-nitrosodimethylamine (NDMA) is clbadified as probable carcinogen. The Zhejiang Huahai study shows that the presence of NDMA is related to changes in manufacturing processes introduced in 2012. This is not related to violations of GMP and any other known active substance. of this undertaking being affected.
Zhejiang Huahai reported these impurities to European end-of-life drug manufacturers who use the active substance valsartan to produce drugs against valsartan, which in turn communicated to the EU regulatory authorities
.
The European Medicines Agency and the relevant national authorities are working together to study the extent of NDMA contamination of drugs containing valsartan and their potential impact on the patients who receive them. Further information on this study will be made available to the public as soon as it becomes available
In collaboration with the manufacturer, work is underway to take the appropriate corrective measures to reduce the levels or eliminate the impurity of future lots of valsartan produced at this production site
Moreover, as a precautionary measure, BDA has blocked medicines containing the active ingredient valsartan provided by Zhejiang Huahai in the EU
There are many other therapeutic alternatives on the Bulgarian pharmaceutical market containing angiotensin-II receptor antagonists
Patients taking medications containing valsartan and having questions about the medications involved should contact a pharmacist and their doctor
Valsartan is an angiotensin II receptor antagonist used to treat high blood pressure, recent myocardial infarction, and heart failure. It is marketed in the pharmaceutical market alone or in combination with other active ingredients
EMA and BDA are actively working to resolve this situation as quickly as possible and will take all necessary measures to protect public health

List of Blocked Medicines
1 Valsavil AM 5 mg / 80 mg film-coated tablets
2 film-coated tablets of Valsavil AM 5 mg / 160 mg
3 film-coated tablets of Valsavil AM 10 mg / 160 mg
4 film-coated tablets of Valtensin 320 mg
5 film-coated tablets of Valtensin 80 mg
6 film-coated tablets of Valtensin 160 mg
7 film-coated tablets of Valstor 160 mg
8 Co-Valstor 160 mg / 12.5 mg film-coated tablets
9 film-coated tablets of Valsalen 160 mg
10 film-coated tablets Valsalen H 160 mg / 12.5 mg
11 film-coated tablets Valsalen H 160 mg / 25 mg
12 film-coated tablets of Valsarcon 160 mg
13 film-coated tablets of Valsarcon 320 mg
14 film-coated tablets of Sarteg 40 mg
15 film-coated tablets of Sarteg 80 mg
16 film-coated tablets of Sarteg 160 mg
17 Sarteg HCT 80 mg / 12.5 mg film-coated tablets
18 Sarteg HCT 160 mg / 12.5 mg film-coated tablets
19 Sarteg HCT film-coated tablets 160 mg / 25 mg
20 film-coated tablets Valtensin Plus 80 mg / 12.5 mg
21 Valtensin Plus 160 mg / 12.5 mg film-coated tablets
22 film-coated tablets Valtensin Plus 160 mg / 25 mg
23 film-coated tablets VAPRESS 80 mg
24 film-coated tablets VAPRESS 160 mg
25 film-coated tablets of Vamadrid 40 mg
26 film-coated tablets of Vamadrid 80 mg
27 film-coated tablets Vamadrid 160 mg
28 film-coated tablets of Vamadrid 320 mg
29 film-coated tablets of Suvartar 160 mg
30 film-coated tablets VALZAP 160 mg
31 film-coated tablets of Valsavil 40 mg
32 film-coated tablets of Valsavil 80 mg
33 film-coated tablets of Valsavil 160 mg
34 film-coated tablets VALZAP H 160 mg / 12.5 mg
35 film-coated tablets of Asbima 5 mg / 800 mg
36 film-coated tablets of Asbima 5 mg / 160 mg
Asbima film-coated tablets 10 mg / 160 mg
38 film-coated tablets of Bevacomb 5 mg / 160 mg
39 film-coated tablets of Bevacomb 10 mg / 160 mg
40 Sartesta film-coated tablets 5 mg / 80 mg
41 Sartesta film-coated tablets 5 mg / 160 mg
42 Sartesta film-coated tablets 10 mg / 160 mg
43 film-coated tablets of Valtensam 5 mg / 160 mg
Valtensam 10 mg / 160 mg film-coated tablets
45 Valsavil Comp 80 mg / 12.5 mg film-coated
46 Valsavil Comp 160 mg / 12.5 mg film-coated
47 film-coated tablets Suvartar H 160 mg / 12.5 mg
48 film-coated tablets of Suvartar H 160 mg / 25 mg
49 Valtensine plus 320 mg / 12.5 mg film-coated tablets
50 Co-Sartroval 160 mg film-coated tablets
51 film-coated tablets of Nortivan Neo 160 mg
52 film-coated tablets of Nortivan 80 mg
53 Nortivan 40 mg film-coated tablets
54 film-coated tablets of Vanatex HCT 80 mg / 12.5 mg
55 film-coated tablets of Vanatex HCT 160 mg / 25 mg
56 film-coated tablets of Vanatex 80 mg
57 film-coated tablets of Vanatex 160 mg
58 film-coated tablets of Valsol plus 160 mg / 25 mg
59 film-coated tablets Valsavil Comp 80 mg / 12.5 mg
60 Tablets Valsavil Comp 160 mg / 12.5 mg
61 Valtensin plus 320 mg / 25 mg film-coated tablets
62 film-coated tablets of 160 mg Valsargamma