Onsenal

celecoxib

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The marketing authorisation for Onsenal has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Onsenal : EPAR - Summary for the public BG = bălgarski 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public ES = español 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public CS = čeština 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public DA = dansk 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public DE = Deutsch 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public ET = eesti keel 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public EL = elliniká 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public EN = English 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public FR = français 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public IT = italiano 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public LV = latviešu valoda 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public LT = lietuvių kalba 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public HU = magyar 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public MT = Malti 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public NL = Nederlands 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public PL = polski 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public PT = português 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public RO = română 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public SK = slovenčina 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public SL = slovenščina 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public FI = suomi 2009-11-09 2011-04-06
Onsenal : EPAR - Summary for the public SV = svenska 2009-11-09 2011-04-06

This EPAR was last updated on 06/04/2011 .

Authorisation details

Product details

Product details for Onsenal
NameOnsenal
Agency product numberEMEA/H/C/000466
Active substance

celecoxib

International non-proprietary name (INN) or common name

celecoxib

Therapeutic area Adenomatous Polyposis Coli
Anatomical therapeutic chemical (ATC) code L01X X33
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Onsenal
Marketing-authorisation holder

Pfizer Limited

Revision13
Date of issue of marketing authorisation valid throughout the European Union17/10/2003

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

28/03/2011  Onsenal -EMEA/H/C/000466 -II/0028

Name Language First published Last updated
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Product Information SV = svenska 2009-11-09 2011-04-06

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.


Name Language First published Last updated
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06
Onsenal : EPAR - All Authorised presentations SV = svenska 2009-11-11 2011-04-06

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

Name Language First published Last updated
Onsenal : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-11-09 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Conclusion SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Steps taken after authorisation when a cutoff date has been used SV = svenska 2005-11-15 2011-04-06

Initial marketing-authorisation documents

Name Language First published Last updated
Onsenal : EPAR - Procedural steps taken before authorisation SV = svenska 2005-11-15 2011-04-06
Onsenal : EPAR - Scientific Discussion SV = svenska 2005-11-15 2011-04-06

Withdrawn

This medicine is now withdrawn from use in the European Union

Related information

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