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For reasons of patient protection, Ukrain, a product promoted, illegally marketed, and used as an anticancer drug, must not be manufactured or offered for sale in Austria. Moreover, individual importation to Austria has been prohibited by decision and use of the product outside of clinical studies has been banned by decree of the Federal Ministry of Health.

According to the pharmaceutical company Nowicky Pharma, Ukrain is a semisynthetic medicinal product manufactured from extracts of greater celandine (Chelidonium alkaloids) and thiotepa.

Situation in Austria
Regulatory approval of the medicinal product Ukrain has been refused by both the Austrian Federal Ministry of Health and the European Commission (on the advice of the EMA Committee for Orphan Medicinal Products). The Austrian Federal Ministry of Health refused to grant regulatory approval because the efficacy, quality, and safety of Ukrain has not been demonstrated. Safety means that, under normal conditions of use, the foreseeable risk of undesirable effects as weighed against the efficacy or the intended purpose of a given medicinal product is acceptable in the light of established medical knowledge.

The company selling this “illegal” medicinal product, i.e., Nowicky Pharma, has not been granted pharmaceutical regulatory approval to either manufacture or sell (place on the market) Ukrain.

For further information:

Federal Office for the Safety in Health Care

MMMag. Bernd Unterkofler

E-Mail: basgbasg.gvat
   
Media:

Communciations

E-Mail: pr_pharmmedagesat