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Active Substance: celecoxib
Common Name: celecoxib
ATC Code: L01X X33
Marketing Authorisation Holder: Pfizer Limited
Active Substance: celecoxib
Status: Withdrawn
Authorisation Date: 2003-10-17
Therapeutic Area: Adenomatous Polyposis Coli
Pharmacotherapeutic Group: Antineoplastic

Therapeutic 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)

The marketing authorisation for Onsenal has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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