Xapit

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Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 22 March 2002, the European Commission granted a marketing authorisation for the whole European Union to Pharmacia Europe EEIG, for Xapit (parecoxib), indicated for the short-term treatment of postoperative pain.

Xapit was not marketed anywhere in the European Union. On 23 January 2004, the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Marketing Authorisation for Xapit as there are no plans to market this product in the future. It should be noted that there are still two Community Marketing Authorisations valid throughout the European Union for medicinal products containing parecoxib, i.e., Dynastat and Rayzon.

On 2 March 2004, the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use Xapit. Pursuant to this decision, the European Public Assessment Report for Xapit has been removed from this website.

Product information

01/03/2004
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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
Xapit
Active substance
parecoxib
International non-proprietary name (INN) or common name
parecoxib
Therapeutic area (MeSH)
Pain, Postoperative
Anatomical therapeutic chemical (ATC) code
M01AH04

Pharmacotherapeutic group

Antiinflammatory and antirheumatic products

Therapeutic indication

For the short-term treatment of postoperative pain.

Authorisation details

EMA product number
EMEA/H/C/000380
Marketing authorisation holder
Pharmacia Europe EEIG

Hillbottom Road
High Wycombe
Buckinghamshire
HP12 4PX
United Kingdom

Marketing authorisation issued
22/03/2002
Withdrawal of marketing authorisation
02/03/2004
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