The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance which the company supplies to manufacturers producing some of the valsartan medicines available in the EU.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.

Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack.

Concerned products

In the grand-duchy of Luxembourg, only the following products are concerned :

• « Valsartan EG® » and « Co-Valsartan EG® » produced by Eurogenerics
• « Valsartan Sandoz® » and « Co-Valsartan Sandoz® » produced by Sandoz
• « Valsartan Ratiopharm® » and « Valsartan Ratiopharm comp.® » produced by Ratiopharm