Ukrain (celandine extract)
The illegally sold and used drug Ukrain, which is advertised as a remedy against cancer, may not be manufactured and sold in Austria for the protection of patients. In addition, individual importation into Austria was prohibited by notice and use outside of clinical trials was prohibited by decree from the Federal Minister of Health.
According to the pharmaceutical company Nowicky Pharma, Ukrain is a semisynthetic drug produced from celandine extracts (Chelidonium alkaloids) and thiotepa.
Situation in Austria
The regulatory approval of the drug Ukrain was rejected by both the Federal Ministry of Health (BMG) and the European Commission (orphan medicinal products). The approval by the BMG was denied in particular because the efficacy, quality and safety of the drug Ukrain could not be proven.
Safety means that, when used as intended, the foreseeable risk of undesirable effects is acceptable when weighed against the efficacy or intended purpose according to the findings of medical science.
The seller of this "illegal" drug, the company Nowicky Pharma, does not have a license under pharmaceutical law to manufacture and sell (place on the market) Ukrain.
Further information:
Information from the German Medicines Agency, Nov. 29, 2011.
Further inquiries
Federal Office for Safety in Health Care
E-mail: basg@basg.gv.at
