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July 7, 2018 | 06:10 | FOCUS News Agency
] Sofia. The Drugs Agency (BDA) blocks 62 pharmaceuticals for the treatment of hypertension, heart attacks and heart failure due to a likely carcinogenic provocation. This is clear from a message posted on the BDA website. 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 the manufacturing process introduced in 2012. The Bugarian Drugs Agency explains that this is not related to established violations of GMP compliance and no it is known that other active substances of this company are affected. Zhejiang Huahai reported on these impurities of end-user manufacturers in the European Union using the active substance valsartan to produce drugs valsartan, which in turn reported to the EU regulatory authorities At a briefing on the subject, Mary Peycheva, Director of the Directorate of Legal, Administrative and Financial Activities and Quality Management of the Bulgarian Medicines Agency, stressed that the suspension of the drugs was preventive. In his own words, the agency has issued a blocking order for drugs, as all other Member States have done, and their pharmacies have already been suspended. Merry Peicheva badured that there are enough alternatives available to replace abandoned products and there is no need to worry. "We have identified the available alternatives to the list of positive drugs currently being downloaded from our site and more than 100. For patients' peace of mind, they could, at the first opportunity, contact their doctor to educate them, she In its opinion, the European Medicines Agency is currently badessing the amount of active substance in valsartan and whether it has reached its end-use level.There is still an badessment of how long patients have been exposed to the substance and if this has led to any influence. "Products containing valsartan are intended for the treatment of hypertension, recent myocardial infarction and heart failure and are considered very widespread, "said Mary Peycheva
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 film-coated tablets 160 mg / 12.5 mg
19 film-coated tablets of Sarteg HCT 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
37 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
44 film-coated tablets of Valtensam 10 mg / 160 mg
45 Valsavil Comp 80 mg / 12.5 mg film-coated
46 Valsavil Comp 160 mg / 12.5 mg film-coated
47 film-coated tablets of 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 film-coated tablets 160 mg / 25 mg
51 film-coated tablets of Nortivan Neo 160 mg
52 film-coated tablets of Nortivan 80 mg
53 film-coated tablets of Nortivan 40 mg
54 film-coated tablets of Vanatex HCT 80 mg / 12.5 mg
Vanatex HCT 160 mg / 25 mg film-coated tablets
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 Valsavil Comp 80 mg / 12.5 mg film-coated tablets
60 Tablets Valsavil Comp 160 mg / 12.5 mg
Valtensin plus 320 mg / 25 mg film-coated tablets
62 film-coated tablets of Valsargamma 160 mg
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