Onsenal (celecoxib)
Exceptional circumstances
- Region
- 🇪🇺 EU
- Active substance
- celecoxib
- Company
- Pfizer Limited
- Status
- Withdrawn
- Therapeutic area
- Adenomatous Polyposis Coli
- EU approval
- Fri 17 Oct 2003
- Designations
- Exceptional circumstances
- Application
- EMEA/H/C/000466
- ATC
- L01XX33
- Official record
- www.ema.europa.eu
Indication
Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4). The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
Regulatory milestones
No milestones recorded in the last year.
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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.