Zelnorm

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tegaserod

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 15 December 2005 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Zelnorm 6 mg tablets.

Following request from the applicant, the CHMP re-examined the opinion and confirmed its previous view on 23 March 2006.

Zelnorm aims to relieve the symptoms of irritable bowel syndrome with constipation in women. Zelnorm is approved outside the European Union for the treatment of irritable bowel syndrome and chronic constipation. The company who applied is Novartis Europharm Limited.

This EPAR was last updated on 31/12/2009

Application details

Product details
Name
Zelnorm
Active substance
tegaserod
International non-proprietary name (INN) or common name
tegaserod
Therapeutic area (MeSH)
Irritable Bowel Syndrome
Anatomical therapeutic chemical (ATC) code
A03AE02
Application details
Marketing-authorisation applicant
Novartis Europharm Limited
Date of opinion
23/03/2006
Date of refusal of marketing authorisation
19/05/2006

Assessment history

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