Onsenal

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celecoxib

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Onsenal has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 06/04/2011

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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

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

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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)

Assessment history

Changes since initial authorisation of medicine

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