| EMA number | EMEA/H/C/000466 |
| ATC code | L01XX33 |
| Authorisation | 17 October 2003 |
| Withdrawn | 28 November 2008 |
| Revision | 13 |
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)