http://www.jelfa.com.pl/en/main/about/events?id=24516Suspension of trading and use of the OMNADREN 250 medicinal product throughout the country.
2010-11-05
Please be advised that the decision of the Main Pharmaceutical Inspector (14/WS/2010) as of 11th March 2010 the following medicinal product is suspended from trading and use throughout the country: OMNADREN 250, solution for injection, 5 ampoules of 1 ml, batch number: 910071, with the expiration date until October 2012.
Having regard to the health and lives of patients and acting in accordance with applicable legislation, Jelfa S.A. decided to inform the CPI on suspecting the existence of counterfeit ampoules of OMNADREN medicinal product in trading, which resulted in making the abovementioned decision.
At the same time, we declare that the OMNADREN medicinal product, for which Jelfa S.A. is Master Authorisation Holder, meets all the quality requirements set out by the law and GMP standards and is completely safe for patients, who use it in accordance with the SPC.
Both the Management and Employees of Jelfa S.A. express their regret at the fact that counterfeit medicinal products are traded. Not only are such dealings detrimental to the reputation of the entrepreneurs operating legally in the pharmaceutical market, but above all it is a threat to the lives and health of people taking those products.
Jelfa S.A., as an aggrieved party in this case, strongly opposes to such actions and declares cooperation in this regard with all public institutions, both administrative bodies, as well as bodies established for the protection of the law in order to find persons responsible for counterfeiting.
