Zelnorm (tegaserod)
- Region
- 🇪🇺 EU
- Active substance
- tegaserod
- Company
- Novartis Europharm Limited
- Status
- Refused
- Therapeutic area
- Irritable Bowel Syndrome
- CHMP opinion
- Thu 23 Mar 2006
- Application
- EMEA/H/C/000621
- ATC
- A03AE02
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Follow Zelnorm
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.