Zelnorm

Refused

This medicine has been refused authorisation

tegaserod

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.

Questions and answers on the recommendation for the refusal of the marketing authorisation for Zelnorm

Reference Number: EMEA/CHMP/109088/2006

Product details

• Name of medicine:
  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

Pharmacotherapeutic group

Drugs for functional gastrointestinal disorders

Application details

• EMA product number:
  EMEA/H/C/000621
• Marketing authorisation applicant:
  Novartis Europharm Limited
• Opinion adopted:
  23/03/2006
• Refusal of marketing authorisation:
  19/05/2006

Assessment history

Zelnorm : EPAR - Refusal public assessment report