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List of referrals for human medicinal products

Protium and associated names

Product name: Protium and associated names
Also marketed in the EU under the name(s): Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk, Pantoc, Pantoloc, PantoLomberg, Pantopan, Pantoprazol, Pantorc, Pantozol, Peptazol, Protium, Rifun, Somac, Ulcotenal, Zurcal, Zurcazol
INN: pantoprazole
Indication: 20 mg gastro-resistant tablets
-Symptomatic gastro-oesophageal reflux disease
-For long-term management and prevention of relapse in reflux oesophagitis
-Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4)
40 mg gastro-resistant tablets
-Reflux oesophagitis
-Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers
-Gastric and duodenal ulcer
-Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions

Intravenous (i.v.) 40 mg powder for solution for injection
-Reflux oesophagitis
-Gastric and duodenal ulcer
-Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
Marketing Authorisation Holder: Nycomed GmbH

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
16/04/2010 Referral EMEA/H/A-30/1002 (2010)2501 of 15/04/2010