Onsenal

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Status: Withdrawn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The marketing authorisation for Onsenal has been withdrawn at the request of the marketing authorisation holder.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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.