Rayzon

RSS
Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 24 June 2005 the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use Rayzon. This followed the notification by the Marketing Authorisation Holder (Pharmacia Europe EEIG) on 21 June 2005 to voluntarily withdraw the Marketing Authorisation for Rayzon as there are no plans to market this product in the future. Rayzon (parecoxib) was indicated for the short-term treatment of postoperative pain. It should be noted that there is still one Community Marketing Authorisation valid throughout the European Union for medicinal products containing parecoxib, i.e. Dynastat. As a consequence to this decision the European Public Assessment Report for Rayzon has been removed from this website.

Product information

24/06/2005
icon globe

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
Rayzon
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.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).

Authorisation details

EMA product number
EMEA/H/C/000382
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
24/06/2005
Revision
4
This page was last updated on

Share this page