Cancellation of state registration. Tramal®

September 29, 2017
Active substances:
Trade names:
ICD-10:
IX.I20-I25.I21    Acute myocardial infarction
XVIII.R50-R69.R52.0    Acute pain
XVIII.R50-R69.R52.2    Another constant pain
Tramal, tramadol, pain, opioid analgesic, pain syndrome, anesthesia

The Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicines" decided to abolish state registration and exclusion from the state register of medicinal products for medical use of medicinalpreparation (registration certificate P N014289 / 03 dated December 12, 2008 issued by STADA Artsynmitler AG, Germany):

Tramal® (trade name of the medicinal product)

Tramadol (international non-proprietary or grouping or chemical name)

solution for injection, 50 mg / ml (dosage form, dosage)

STADA Arzneimittel AG, Germany Stadastrasse 2-18 6P18 Bad Vilbel, German (name and address of the location of the manufacturer of the medicinal product)

on the basis of filing by an authorized legal entity of Nizhpharm, an application for the cancellation of the state registration of a medicinal product.