Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Losec and associated names

Product name: Losec and associated names
Also marketed in the EU under the name(s): Antra, Logastric, Mepral, Mopral, Omeprazen, Omeprazole, Zoltum
INN: omeprazole
Indication: Duodenal ulcers, gastric ulcers, NSAID-associated ulcers, Helicobacter pylori eradication in peptic ulcer disease, reflux oesophagitis and symptomatic gastro-oesophageal reflux disease and for the treatment of Zollinger-Ellison syndrome.
Marketing Authorisation Holder: AstraZeneca

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/06/2010 Referral EMEA/H/A-30/1001 (2010)3894 of 10/06/2010