- 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
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 productsTherapeutic 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).