Cancellation of state registration. Omeprazole Zentiva

June 15, 2018
Active substances:
ICD-10:
IV.E15-E16.E16.8    Other specified disorders of internal secretion of the pancreas
XI.K20-K31.K21    Gastroesophageal reflux
XI.K20-K31.K21.0    Gastroesophageal reflux with esophagitis
XI.K20-K31.K25    Stomach ulcer
XI.K20-K31.K26    Duodenal ulcer
XI.K20-K31.K27    Peptic ulcer of unspecified site
XI.K20-K31.K30    Dyspepsia
XVIII.R10-R19.R11    Nausea and vomiting
XVIII.R10-R19.R12    Heartburn
XVIII.R10-R19.R14    Meteorism and related conditions
XX.Y40-Y59.Y45    Analgesic, antipyretic and anti-inflammatory agents
Omeprazole, gastric ulcer, treatment of gastric ulcer, duodenal ulcer, treatment of duodenal ulcer, dyspepsia, esophagitis, gastroesophageal reflux, reflux esophagitis

The Ministry of Health of the Russian Federation in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On 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 N011336 / 01 from 18.05.2010 issued by Zentiva, Czech Republic):

Omeprazole Zentiva (trade name of the medicinal product)

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

capsules, enteric, 10 mg, 20 mg (dosage form, dosage)

Saneka Pharmaceuticals as, Slovak Republic Nitrianska 100, 920 27 Hlohovec, Slovak Republic Zentiva, Czech Republic U kabelovny 130, 102 37 Prague 10, Dolni Mecholupy, Czech Republic (name and address of the location of the manufacturer of the medicinal product)

on the basis of an application by the authorized legal entity of the Sanofi-aventis Group JSC to cancel the state registration of the medicinal product.