Onsenal
celecoxib
Table of contents
Overview
The marketing authorisation for Onsenal has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Onsenal
|
| Agency product number |
EMEA/H/C/000466
|
| Active substance |
Celecoxib
|
| International non-proprietary name (INN) or common name |
celecoxib
|
| Therapeutic area (MeSH) |
Adenomatous Polyposis Coli
|
| Anatomical therapeutic chemical (ATC) code |
L01XX33
|
Exceptional circumstances |
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Pfizer Limited
|
| Revision |
13
|
| Date of issue of marketing authorisation valid throughout the European Union |
17/10/2003
|
| Contact address |
Ramsgate Road
Sandwich Kent CT13 9NJ United Kingdom |
Product information
28/03/2011 Onsenal - EMEA/H/C/000466 - II/0028
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
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)