Cancellation of state registration. Ketolac®

June 23, 2017
Active substances:
Trade names:
ICD-10:
XVIII.R50-R69.R52.0    Acute pain
XVIII.R50-R69.R52.2    Another constant pain
Ketolac, ketorolac, pain, pain treatment, headache, toothache, chronic pain

The Ministry of Health of the Russian Federation in accordance with articles 29 and 32 of the Federal Law of 12.04.2010 No. 61-FZ "On circulation of medicines" decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate LP- 001778 dated 23.07.2012, issued by "Altayvitaminy" CJSC, Russia):

Ketolac® (trade name of the medicinal product)

Ketorolac (international nonproprietary, or corpse pyrochnoe, or chemical name medicinal product)

solution for intravenous and intramuscular injection, 30 mg / ml (dosage form, dosage)

JSC "Altayvitaminy", Russia 659325, Altai Territory, Biysk, ul. Zavodskaya, house 69 (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 relationship between the expected benefit and the possible risk of drug use.