The Ministry of Health of the Russian Federation in accordance with Article 29 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicinal products" and on the basis of the submitted application No. 72599 (in No. 4023924 of September 15, 2016) and documents based on the results of the expert examinations, on the refusal to confirm the state registration of a medicinal product for medical use:
Spazmil-M (trade name of the medicinal product)
- (international non-proprietary, or grouping, or chemical name medicinal product)
pills (dosage form, dosage)
Sopharma AO, Bulgaria 1220, Sofia, 16 Iliensko Shosse Str., Bulgaria (name and address of the place of production)
in connection with the non-confirmation of the state registration of the medicinal product for medical use according to the results of the examination of the quality of the medicinal product and the examination of the relationship of the expected benefit to the possible risk of drug use.