🇪🇺 Zelnorm in European Union

EMA authorised Zelnorm on 31 December 2009

Marketing authorisation

EMA — authorised 31 December 2009

  • Application: EMEA/H/C/000621
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Zelnorm
  • Indication: Zelnorm is indicated for the repeated symptomatic short-term treatment of women with Irritable Bowel Syndrome (IBS) whose predominant bowel habit is constipation, associated with abdominal pain/discomfort or bloating (see section 4.2).
  • Status: rejected

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Zelnorm in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in European Union

Frequently asked questions

Is Zelnorm approved in European Union?

Yes. EMA authorised it on 31 December 2009.

Who is the marketing authorisation holder for Zelnorm in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.