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The marketing authorisation for Onsenal has been withdrawn at the request of the marketing authorisation holder.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 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public ES = español 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public CS = čeština 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public DA = dansk 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public DE = Deutsch 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public ET = eesti keel 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public EL = elliniká 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public EN = English 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public FR = français 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public IT = italiano 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public LV = latviešu valoda 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public LT = lietuvių kalba 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public HU = magyar 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public MT = Malti 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public NL = Nederlands 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public PL = polski 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public PT = português 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public RO = română 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public SK = slovenčina 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public SL = slovenščina 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public FI = suomi 09/11/2009 06/04/2011
Onsenal : EPAR - Summary for the public SV = svenska 09/11/2009 06/04/2011

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

More detail is available in the summary of product characteristics

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 BG = bălgarski 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information ES = español 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information CS = čeština 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information DA = dansk 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information DE = Deutsch 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information ET = eesti keel 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information EL = elliniká 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information EN = English 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information FR = français 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information IT = italiano 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information LV = latviešu valoda 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information LT = lietuvių kalba 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information HU = magyar 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information MT = Malti 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information NL = Nederlands 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information PL = polski 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information PT = português 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information RO = română 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information SK = slovenčina 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information SL = slovenščina 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information FI = suomi 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information SV = svenska 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information IS = Islenska 09/11/2009 06/04/2011
Onsenal : EPAR - Product Information NO = Norsk 09/11/2009 06/04/2011

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 ES = español 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations DA = dansk 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations DE = Deutsch 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations EL = elliniká 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations EN = English 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations FR = français 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations IT = italiano 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations NL = Nederlands 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations PT = português 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations FI = suomi 11/11/2009 06/04/2011
Onsenal : EPAR - All Authorised presentations SV = svenska 11/11/2009 06/04/2011

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 (English only) 09/11/2009 06/04/2011
Onsenal : EPAR - Scientific Conclusion ES = español 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion CS = čeština 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion DA = dansk 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion DE = Deutsch 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion ET = eesti keel 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion EL = elliniká 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion EN = English 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion FR = français 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion IT = italiano 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion LV = latviešu valoda 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion LT = lietuvių kalba 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion HU = magyar 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion NL = Nederlands 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion PL = polski 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion PT = português 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion SK = slovenčina 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion SL = slovenščina 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion FI = suomi 15/11/2005 06/04/2011
Onsenal : EPAR - Scientific Conclusion SV = svenska 15/11/2005 06/04/2011
Onsenal : EPAR - Steps taken after authorisation when a cutoff date has been used (English only) 15/11/2005 06/04/2011

Initial marketing-authorisation documents

Name Language First published Last updated
Onsenal : EPAR - Scientific Discussion (English only) 15/11/2005 06/04/2011
Onsenal : EPAR - Procedural steps taken before authorisation (English only) 15/11/2005 06/04/2011

Withdrawn

This medicine is now withdrawn from use in the European Union

Related information

More information on Onsenal