Cancellation of state registration. Tramadol (suppositories rectal)

December 07, 2016
Active substances:
Trade names:
ICD-10:
XVIII.R50-R69.R52.2    Another constant pain
XVIII.R50-R69.R52.0    Acute pain
Tramadol, opioid analgesic, pain, pain treatment

The Ministry of Health of the Russian Federation, in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On the circulation of medicinal products", decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate P N012155 / 04 from 25.10.2010 issued by JSC "Krka, dd, Novo mesto", Slovenia):

Tramadol (trade name of the drug)

Tramadol (international non-proprietary, or grouping, or chemical name medicinal product)

suppositories rectal, 100 mg (dosage form, dosage)

JSC "Krka, dd, Novo mesto", Slovenia Smarjeska cesta 6, 8501 Novo mesto, Slovenia (name and address of the location of the manufacturer of the medicinal product)

on the basis of the submission by the authorized representative of the JSC "Krka, dd, Novo mesto", Russia, a statement on the abolition of the state registration of the medicinal product.