Pharmaceuticals - Community Register

  

List of nationally authorised medicinal products for human use

Domperidone Art 31

Product name: Domperidone Art 31
Also marketed in the EU under the name(s): BIPERIDYS, CILROTON, Cinet, Cinnarizine/ Domperidone maleate, Costi, DALIA, DIGESTIVO GIULIANI, DOMERID, Domperidon, Domperidona, Domperidone, Domperitop, Domstal, GERDI, Motilium, Nauzelin, NEOPERIDYS, Oroperidys, PERIDON, PERIDYS, PERMOTIL, PYNINAT, RAXAR, Remotil, RIGES, Tametil, Touristil, Zilium
Active substance: domperidone
Indication: domperidone is indicated for: dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux, and oesophagitis:
• epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain
• bloating, eructation, flatulence
• nausea and vomiting
• heartburn with or without regurgitations of gastric contents in the mouth
• Nausea and vomiting of functional, organic, infectious or dietetic origin
• Nausea and vomiting induced by:
• radiotherapy or drug therapy
• dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson’s disease
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
15/07/2014 Referral EMEA/H/A-31/1365 (2014)5113 of 14/07/2014
06/08/2014 Corrigendum (2014)5759 of 05/08/2014
02/09/2014 Rectificative Decision (2014)6263 of 01/09/2014