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Generic medications removed contain active substance valsartan in which NDMA impurity was detected – Drugs are for patients with high blood pressure and patients with heart failure or seizure heartbeat – Which medications are available in Greece? From the Agency of Medicines
The withdrawal of the batch of drugs containing the active substance valsartan produced by the Chinese company Zhejiang Huahai Pharmaceuticals was announced by the European Medicines Agency (EMA) and l & # 39; National Medicines Agency (EMA)
Valsartan drugs are used to treat patients, to reduce complications such as heart attacks and strokes. It has also been used in patients with heart failure or recent heart attack
. A drug N-nitrosodimethylamine (NDMA) has been detected in the active substance valsartan that the company provides to manufacturers in the European Union.
EMMA describes NDMA as a potential human carcinogen (a substance that can cause cancer) according to the results of laboratory tests. "The presence of NDMA was unexpected and would be linked to changes in the way the active substance is manufactured," says the EMEA press release.
Which drugs are available in Greece
While revision is underway, throughout the European Union withdraw drugs containing vesartan Zhejiang Huahai
The active substance valsartan was initially developed by the pharmaceutical company Novartis under the brand name Diovan. However, after taking the patent, it is used in many generic drugs that are available on the European market
In Greece, in particular, 5 drugs Zhejiang Huahai Pharmaceuticals from Iasis Pharma, Medochemie Hellas, Lyofin LTD Greece, Pharmazak, Bennett Pharmaceuticals, Gap AE and Novartis / Sandoz
"IEC companies need to communicate directly with their customers to remove them from the market," says Efko
What EMA experts recommend to patients
? ] The EMA study will look at NDMA levels in valsartan drugs, their likely impact on the patients who take them and the steps that can be taken to reduce or eliminate the impurity of future batches. produced by the company
As a precaution, the review will also consider whether
EMEA experts give the following information to patients:
Unexpected impurity was found in the active ingredient used in the manufacture of certain drugs against valsartan
Valsartan drugs in the European Union are concerned and are being revoked
You do not have to do not stop taking Valsartan unless your doctor or pharmacist tells you
You may be receiving a different valsartan (or alternative treatment) with your next prescription
If you have q uestions on your treatment, talk to your pharmacist who can tell you if your medicine is revoked
. If you have questions about your treatment, talk to your pharmacist. clinical trial with valsartan and you have questions, talk to the doctor who cures you in the clinical trial
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