Onsenal

RSS
Withdrawn

This medicine's authorisation has been withdrawn

celecoxib
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Onsenal has been withdrawn at the request of the marketing authorisation holder.

Onsenal : EPAR - Summary for the public

English (EN) (268.74 KB - PDF)

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български (BG) (413.76 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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español (ES) (330.59 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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čeština (CS) (382.99 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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dansk (DA) (329.69 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Deutsch (DE) (330.69 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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eesti keel (ET) (328.93 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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ελληνικά (EL) (419.21 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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français (FR) (330.54 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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italiano (IT) (330.09 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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latviešu valoda (LV) (387.05 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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lietuvių kalba (LT) (355.07 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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magyar (HU) (378.98 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Malti (MT) (398.93 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Nederlands (NL) (328.95 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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polski (PL) (384.61 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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português (PT) (330 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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română (RO) (354.09 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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slovenčina (SK) (382.91 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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slovenščina (SL) (378.8 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Suomi (FI) (329.99 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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svenska (SV) (329.33 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Product information

Onsenal : EPAR - Product Information

English (EN) (701.2 KB - PDF)

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български (BG) (1.75 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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español (ES) (808.39 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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čeština (CS) (1.27 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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dansk (DA) (787.42 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Deutsch (DE) (828.55 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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eesti keel (ET) (791.7 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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ελληνικά (EL) (1.87 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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français (FR) (850.82 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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íslenska (IS) (800.8 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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italiano (IT) (811.86 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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latviešu valoda (LV) (1.35 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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lietuvių kalba (LT) (810.35 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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magyar (HU) (1.39 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Malti (MT) (1.46 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Nederlands (NL) (803.39 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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norsk (NO) (778.55 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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polski (PL) (1.44 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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português (PT) (827.81 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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română (RO) (821.02 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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slovenčina (SK) (1.4 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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slovenščina (SL) (1.27 MB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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Suomi (FI) (802.87 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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svenska (SV) (767.89 KB - PDF)

First published: 09/11/2009Last updated: 06/04/2011
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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

English (EN) (326.99 KB - PDF)

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

English (EN) (307.01 KB - PDF)

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Onsenal : EPAR - Scientific Conclusion

English (EN) (297.46 KB - PDF)

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español (ES) (298.99 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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čeština (CS) (342.77 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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dansk (DA) (303.87 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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Deutsch (DE) (306.78 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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eesti keel (ET) (297.18 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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ελληνικά (EL) (382.68 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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français (FR) (303.88 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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italiano (IT) (296.88 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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latviešu valoda (LV) (363.8 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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lietuvių kalba (LT) (334.44 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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magyar (HU) (342.38 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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Nederlands (NL) (301.31 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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polski (PL) (356.38 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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português (PT) (305.83 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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slovenčina (SK) (343.33 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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slovenščina (SL) (342.21 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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Suomi (FI) (300.62 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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svenska (SV) (300.06 KB - PDF)

First published: 15/11/2005Last updated: 06/04/2011
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Onsenal : EPAR - Procedural steps taken before authorisation

English (EN) (294.76 KB - PDF)

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Onsenal : EPAR - Scientific Discussion

English (EN) (583.45 KB - PDF)

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More information on Onsenal

Public statement on Onsenal (celecoxib) - Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/232752/2011

English (EN) (50.25 KB - PDF)

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This product was originally designated an orphan medicine on 20 November 2001. Onsenal was withdrawn from the Community register of orphan medicinal products by the European Commission in March 2011 at the time of the withdrawal of the marketing authorisation.

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