Overview

The marketing authorisation for Onsenal has been withdrawn at the request of the marketing authorisation holder.

Onsenal : EPAR - Summary for the public

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Product information

Onsenal : EPAR - Product Information

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Latest procedure affecting product information: II/0028

28/03/2011

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

Product details

Name of medicine
Onsenal
Active substance
Celecoxib
International non-proprietary name (INN) or common name
celecoxib
Therapeutic area (MeSH)
Adenomatous Polyposis Coli
Anatomical therapeutic chemical (ATC) code
L01XX33

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)

Authorisation details

EMA product number
EMEA/H/C/000466

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.

Marketing authorisation holder
Pfizer Limited

Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Marketing authorisation issued
17/10/2003
Revision
13

Assessment history

Onsenal : EPAR - Procedural steps taken and scientific information after authorisation

Onsenal : EPAR - Steps taken after authorisation when a cutoff date has been used

Onsenal : EPAR - Scientific Conclusion

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Suomi (FI) (300.62 KB - PDF)
svenska (SV) (300.06 KB - PDF)

Onsenal : EPAR - Procedural steps taken before authorisation

Onsenal : EPAR - Scientific Discussion

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