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13 August, 2020
 
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Cyprus recalls unsuitable medical drugs

European regulators recall generic heart drug made in China on cancer fears

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A number of high blood pressure and heart drugs containing an ingredient made in China are being recalled across Europe after officials discovered an impurity that may cause cancer.

The European Medicines Agency (EMA) said the recall was based on the identification of an impurity in the active ingredient Valsartan, which is manufactured by Chinese pharmaceutical company Zhejiang Huahai.

Valsartan (valsartan systemic) is a member of the drug class angiotensin receptor blockers and is used to treat Heart Attack, Heart Failure, High Blood Pressure and Left Ventricular Dysfunction.

It was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines.

Cyprus Pharmaceutical Services department shared a list of affected drugs in the local market as well as alternatives that are not known to be affected by the impurity N-nitrosodimethylamine (NDMA).

The department is also calling on patients to stop taking the affected drugs and return it to their pharmacist, as well as talk to their doctor about possible generic alternatives or and other treatments.

Name of affected medications with serial numbers

Vapress 40mg Film Coated Tablets - all batches
Vapress 80mg Film Coated Tablets - all batches
Vapress 160mg Film Coated Tablets - all batches
Sartovan 80mg Film Coated Tablets - all batches
Sartovan 160mg Film Coated Tablets - all batches
Troval 80mg Film Coated Tablets - batches: 15361 and 16273
Troval 160mg Film Coated Tablets - batches: 15362 and 16274
Cotroval 160/12.5mg Film Coated Tablets – batch: 15133
Cotroval 160/25mg Film Coated Tablets – batch: 15134
Valsartan Zentiva 40mg Film Coated Tablets - all batches
Valsartan Zentiva 160mg Film Coated Tablets - all batches

Non-affected medications (with active ingredients)

Diovan Film Coated Tablets 40mg (Valsartan)
Diovan Film Coated Tablets 80mg (Valsartan)
Diovan Film Coated Tablets 160mg (Valsartan)
Co-Diovan Film Coated Tablets 80/12,5mg (Valsartan/Hydrochlorothiazide)
Co-Diovan Film Coated Tablets 160/12,5mg (Valsartan/Hydrochlorothiazide)
Co-Diovan Film Coated Tablets 160/25mg (Valsartan/Hydrochlorothiazide)
Entresto Film Coated Tablets (24+26) mg (Valsartan/Sacubitril)
Entresto Film Coated Tablets (49+51) mg (Valsartan/Sacubitril)
Entresto Film Coated Tablets (97+103) mg (Valsartan/Sacubitril)
Exforge Film Coated Tablets 80/5mg (Valsartan/Amlodipine Besylate)
Exforge Film Coated Tablets 160/5mg (Valsartan/Amlodipine Besylate)
Exforge Film Coated Tablets 160/10mg (Valsartan/Amlodipine Besylate)
Exforge HCT Film Coated Tablets 160/5/12,5mg (Valsartan/Amlodipine Besylate)
Exforge HCT Film Coated Tablets 160/5/25mg (Valsartan/Amlodipine Besylate/Hydrochlorothiazide)
Exforge HCT Film Coated Tablets 160/10/12,5mg (Valsartan/Amlodipine Besylate/Hydrochlorothiazide)
Exforge HCT Film Coated Tablets 160/10/25mg (Valsartan/Amlodipine Besylate/Hydrochlorothiazide)

TAGS
Cyprus  |  Valsartan  |  heart  |  high blood pressure  |  medicine  |  recall

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