Mometasone Furoate Sandoz

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

Overview

On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mometasone Furoate Sandoz. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks, and that the marketing authorisation can be granted in the Netherlands and in the following Member States of the EU: Belgium, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway.

Key facts

Approved name
Mometasone Furoate Sandoz
International non-proprietary name (INN) or common name
mometasone furoate
Associated names
  • Mometasone Sandoz
  • Mometasone Sandoz 50
  • Mometasone Furoato Sandoz 50
  • Mommox
  • Nasometi
  • Fumomo 50
Class
Glucocorticoids
Reference number
EMEA/H/A-29/1332
Type
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.

Status
European Commission final decision
Opinion date
19/07/2012
EC decision date
08/10/2012

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:

How useful was this page?

Add your rating
Average
1 rating
1 rating