Kantos Master

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

Overview

On 17 January 2013, the European Medicines Agency completed an arbitration procedure for Kantos Master and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new use as rescue therapy for acute relief of asthma symptoms. The Committee concluded that the benefits of Kantos Master outweigh its risks in the new use and the change to the marketing authorisation can be granted in Germany and the following Member States: Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovenia, Spain, Sweden and the United Kingdom.

Key facts

Approved name
Kantos Master
International non-proprietary name (INN) or common name
beclomethasone dipropionate / formoterol fumarate
Associated names
  • Kantos
  • Formodual
  • Foster
  • Inuxair
  • Innovair and associated names
Class
-
Reference number
EMEA/H/A-13/1350
Type
Article 13 referrals

This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
17/01/2013
EC decision date
10/04/2013

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:

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