Cancellation of state registration. Esomeprazole Zentiva

May 8, 2018
Active substances:
ICD-10:
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
Esomeprazole Zentiva, esomeprazole, gastric ulcer, treatment of gastric ulcer, duodenal ulcer, treatment of duodenal ulcer, erosive reflux-esophagitis, antiulcer drug

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 medicinal products" decided to abolish state registration and exclusion from the state register of medicinal products for medical use of the medicinal product (registration certificate LP-003136 dated August 10, 2016 issued by Zentiva, Czech Republic):

Esomeprazole Zentiva (trade name of the medicinal product)

Esomeprazole (international non-proprietary or grouping or chemical name) tablets, enteric, film-coated, 20 mg, 40 mg (dosage form, dosage)

Etipharm, France Chemin de la Poudriere, 76120 Gand Quevilly, France Zone industrielle de Saint Arnoult, 28170 Chateauneuf-en-Thymerais, France (name and address of the location of the manufacturer of the medicinal product)

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