Mometasone Furoate Sandoz
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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 |
|
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
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Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) (PDF/68.25 KB)
First published: 20/07/2012
Last updated: 24/01/2013
EMA/476365/2012 -
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Mometasone Furoate Sandoz - Article-29(4) referral - Assessment report (PDF/138.53 KB)
Adopted
First published: 24/01/2013
Last updated: 24/01/2013
EMA/CHMP/573035/2012 -
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Mometasone Furoate Sandoz - Article-29(4) referral - Annex I (PDF/150.34 KB)
First published: 24/01/2013
Last updated: 24/01/2013 -
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Mometasone Furoate Sandoz - Article-29(4) referral - Annex II (PDF/42.82 KB)
First published: 24/01/2013
Last updated: 24/01/2013 -
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Mometasone Furoate Sandoz - Article-29(4) referral - Annex III (PDF/33.09 KB)
First published: 24/01/2013
Last updated: 24/01/2013 -
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