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B92 confirmed: "ranitidine" and "wounded" withdrawn from the Serbian trit



Due to warnings issued by the European Medicines Agency, the drugs "ranitidine" and "wounded" are being withdrawn from Serbian tritium.


Source: B92

Illustration / Photo: taniec / depositphotos

Illustration / Photo: taniec / depositphotos

"This is a voluntary decision of the manufacturer. These drugs are being phased out not only in Serbia, but in many countries, because some errors were found in them, "said B92 Paul Zelly, spokesman for the Drug Agency, repeating that manufacturers were making their own decisions. to prevent these drugs from being removed from wheat.

Earlier today, Hemofarm said it had decided to withdraw 'ranitidine' from tritium, which contains the active substance ranitidine hydrochloride, and according to a warning from the European Medicines Agency, an impurity called N-nitrosodimethylamine has been detected in the active substance (NDMA).

The European Medicines Agency (EMA) document raised doubts about the possible harmful effects of a certain amount of unclean NDMA on human health, which will be confirmed or rejected in subsequent studies. The European Medicines Agency, in close cooperation with national medicine agencies, verifies all ready medicines containing the active substance ranitidine hydrochloride from various manufacturers. The audit began on September 12 and is being carried out by the Humanities Medicines Committee (CHMP), whose determination will be legally binding for all EU countries, including Hemofarm, which operates in accordance with European principles, and travel, according to this company.

Ranitidine contains the active substance ranitidine, which belongs to the group of H2 receptor antagonists. It is intended for the treatment of certain diseases and diseases in which elucid acid leaching is intensified. It is also used to treat elk on elk, duodenum, postoperative etc.

In the territory of the Republic of Serbia, ranitidine is available in the form of coated tablets, capsule tablets and solution for injection and is available to patients without a prescription or by prescription.

All patients using ranitidine are provided with a suitable famotidine HF replacement, which is available on prescription and can be found in pharmacies.

Famotidine HF contains the active substance famotidine (20 mg or 40 mg), which, like ranitidine, belongs to the group of H2 receptor antagonists and is used in the same health indications as ranitidine.


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