• Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision


Rapinyl and associated names, 50ug, 100ug, 200ug, 300ug, 400ug, 600ug, 800ug, sublingual tablets is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.

ProStrakan Ltd submitted applications for Rapinyl and associated names, 50ug, 100ug, 200ug, 300ug, 400ug, 600ug, 800ug, sublingual tablets. The Decentralised Procedure, SE/H/575/07/DC, started on 1 September 2006.

The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain and
United Kingdom.

These Member States were not able to reach an agreement and Sweden referred the reasons for disagreement to the EMEA on 27 September 2007.

Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/risk and the lack of PK data under normal conditions of use of the product. This refers to the bridging strategy of the Applicant and was considered to be a serious public health concern.

The arbitration procedure started on 18 October 2007 with the adoption of a list of questions. The Rapporteur was Dr Tomas Salmonson (SE) and Dr Pierre Demolis (FR) was Co-Rapporteur. The Applicant provided written explanations on 7 April 2008.

During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended. A positive opinion was adopted by consensus on 26 June 2008

The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.

The final opinion was converted into a Decision by the European Commission on 11 September 2008.

Key facts

Approved name
International non-proprietary name (INN) or common name
fentanyl citrate
Reference number
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

European Commission final decision
Opinion date
EC decision date

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

How useful was this page?

Add your rating
1 rating