JSC Grindeks reports on information received on 5th and 6th February 2009 at Regional Offices of State Agency of Medicines of Russian Federation (hereinafter ROSZDRAVNADZOR) in Penza, Chelyabinsk, Kurgan, Nizhegorod districts from Regional Drug Safety Monitoring Centers regarding severe cases of side effects using Mildronate injections 0.5 g (ampoules) 5 ml series 260808 and 290808 produced by Russian CJSC “FarmFirma “Soteks”. Severe side effects occurred in form of anaphylactic shock and respiratory and cardiac arrest.
Upon receival of the official information reporting on several harmful effects caused to health after the use of Mildronate injections produced by Russian FarmFirma „Soteks”, Grindeks acted immediately according to the Pharmacovigilance requirements. These reports were sent to the manufacturer of injections FarmFirma „Soteks” and also to the distributor. The suspension of further distribution of Mildronate injections produced by FarmFirma „Soteks” was requested. The reports were presented to State Agency of Medicines of Latvia, State Agency of Medicines of Lithuania, ROSZDRAVNADZOR in Russia and EMEA as well.
Central Bureau of ROSZDRAVNADZOR suspended the distribution of this medication in the territory of Russian Federation until clarification of circumstances. Further relevant controlling procedures detected error in manufacturing process of CJSC FarmFirma „Soteks” during which ampoules of Listenon injections 2% 5 ml were labeled as Mildronate injections 0.5 g (ampoules) 5 ml. The fact was approved after the quality analyses of Mildronate injections 0.5 g (ampoules) 5 ml series 260808 and 290808 were done.
ROSZDRAVNADZOR recalled from circulation all 98 series of Mildronate injections 0.5 g (ampoules) 5 ml produced by Russian CJSC FarmFirma „Soteks” and published relevant statements on its official website (www.roszdravnadzor.ru).
According to data of Drug Safety Monitoring Center of Russian Federation no severe side effects while using medication were detected since 17th February 2009.
Due to essential breach of licensing requirements and conditions for the production of medicines, ROSZDRAVNADZOR has brought a claim against CJSC “FarmFirma “Soteks” in accordance with the Part 4, paragraph 14.1 of the Administrative Code of the Russian Federation at Arbitration Court of Moscow. Materials of inspection have been submitted to the law enforcement institutions.
Director of Latvian Institute of Organic Synthesis, inventor of Mildronate Ivars Kalviņš: “Mildronate is presented in the market more than 20 years. During the last five years this medication is used by more than 12 millions patients, and such complaints have never occurred previously. Contrary – due to unique action of Mildronate in optimizing oxygen demand, it can be used effectively in the treatment of different diseases caused by oxygen deficiency. It is possible to use Mildronate for the treatment of atherosclerosis, heart failures, heart attacks, stenocardia, thrombus etc. The medication is very tolerant with few side effects. The doctors and patients evaluate positively the impact of Mildronate.”
According to the agreement signed between Grindeks and CJSC “Farmfirma „Soteks” in August 2008, manufacturing of Mildronate injections in Russia until this was carried out by CJSC “Farmfirma „Soteks” and these medications were distributed only in the territory of Russia.
Chairman of the Board of Grindeks Jānis Romanovskis: “Because of crude error in manufacturing process of Russian CJSC “Farmfirma „Soteks”, another product was labeled as Mildronate. Grindeks will provide Russian patients with Mildronate injections produced in European Union.
JSC Grindeks is the leading pharmaceutical company in the Baltic States. Its main fields of action are research, development and manufacturing of original products, generics and active pharmaceutical ingredients. Grindeks specializes in the heart and cardiovascular, CNS and anti-cancer medication therapeutic groups.
A range of products covers a successful combination of original products and generics, with the original products Mildronate® and Ftorafur® and more than 100 forms of effective and safe generics included therein.
Grindeks concern consists of four subsidiary companies in Latvia, Estonia and Russia, as well representatives and representative offices in fourteen countries. Products of the company are exported to more than 40 countries and its export comprises more than 96% of the total turnover. The main markets are the Baltic States, Russia and other CIS countries, Japan, USA. The shares of JSC Grindeks are listed in the Official List of „Nasdaq OMX Riga”.
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