Mometasone Furoate Sandoz

  • Email
  • Help

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.

What is Mometasone Furoate Sandoz?

Mometasone Furoate Sandoz is a medicine that contains the active substance mometasone furoate. It is available as a nasal spray. Mometasone Furoate Sandoz is used in adults and children from six years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever, or which occurs throughout the year). It is also used to prevent moderate to severe symptoms of seasonal allergic rhinitis before the pollen seasons starts. In addition, it is used in adults to treat the symptoms of nasal polyps (growths in the lining of the nose).

The active substance, mometasone furoate, belongs to the group ‘glucocorticoids’. It works by attaching to receptors in various types of immune cells, leading to a reduction in the release of substances that are involved in the inflammation process, and thereby reducing the symptoms of allergy.

Mometasone Furoate Sandoz is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ already authorised in the EU that contains the same active substance, but which is given using a different type of nasal spray device. The ‘reference medicine’ for Mometasone Furoate Sandoz is called Nasonex.

Why was Mometasone Furoate Sandoz reviewed?

Sandoz B.V. submitted an application for Mometasone Furoate Sandoz to the Dutch medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance 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).

However, the Member States were not able to reach an agreement, and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.

The grounds for the referral were concerns over the type of in vitro (experimental) studies carried out to demonstrate that Mometasone Furoate Sandoz is comparable to Nasonex (that it produces the same levels of the active substance in the nose as Nasonex). The Spanish agency therefore considered that the results from the in-vitro studies could not be used to predict how well the medicine would work in patients. In addition, there were concerns over the methodology used to analyse these in-vitro results.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP recognised some of the concerns of the Spanish agency, but concluded that overall it was sufficiently demonstrated that possible differences between Mometasone Furoate Sandoz and the reference medicine would not affect the benefit-risk balance of the product, taking all the in vitro data into account. Also, data from a clinical study provided additional evidence that Mometasone Furoate Sandoz nasal spray works as well as Nasonex nasal spray in patients. The CHMP therefore concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.

The European Commission issued a decision on 8 October 2012.

Name Language First published Last updated
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) BG = bălgarski 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) ES = español 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) CS = čeština 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) DA = dansk 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) DE = Deutsch 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) ET = eesti keel 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) EL = elliniká 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) EN = English 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) FR = français 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) IT = italiano 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) LV = latviešu valoda 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) LT = lietuvių kalba 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) HU = magyar 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) MT = Malti 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) NL = Nederlands 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) PL = polski 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) PT = português 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) RO = română 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) SK = slovenčina 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) SL = slovenščina 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) FI = suomi 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) SV = svenska 20/07/2012 24/01/2013

Key facts

Approved nameMometasone Furoate Sandoz
International non-proprietary name (INN) or common name

mometasone furoate

Associated namesMometasone Sandoz, Mometasone Sandoz 50, Mometasone Furoato Sandoz 50, Mommox, Nasometi, Fumomo 50
ClassGlucocorticoids
Reference numberEMEA/H/A-29/1332
TypeArticle 29(4) referrals

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

StatusEuropean Commission final decision
Opinion date19/07/2012

All documents

Name Language First published Last updated
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) BG = bălgarski 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) ES = español 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) CS = čeština 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) DA = dansk 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) DE = Deutsch 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) ET = eesti keel 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) EL = elliniká 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) EN = English 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) FR = français 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) IT = italiano 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) LV = latviešu valoda 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) LT = lietuvių kalba 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) HU = magyar 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) MT = Malti 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) NL = Nederlands 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) PL = polski 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) PT = português 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) RO = română 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) SK = slovenčina 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) SL = slovenščina 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) FI = suomi 20/07/2012 24/01/2013
Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose) SV = svenska 20/07/2012 24/01/2013
Mometasone Furoate Sandoz - Article-29(4) referral - Assessment report (English only) 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I BG = bălgarski 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I ES = español 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I CS = čeština 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I DA = dansk 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I DE = Deutsch 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I ET = eesti keel 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I EL = elliniká 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I EN = English 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I FR = français 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I IT = italiano 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I LV = latviešu valoda 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I LT = lietuvių kalba 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I HU = magyar 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I MT = Malti 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I NL = Nederlands 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I PL = polski 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I PT = português 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I RO = română 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I SK = slovenčina 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I SL = slovenščina 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I FI = suomi 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex I SV = svenska 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II BG = bălgarski 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II ES = español 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II CS = čeština 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II DA = dansk 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II DE = Deutsch 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II ET = eesti keel 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II EL = elliniká 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II EN = English 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II FR = français 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II IT = italiano 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II LV = latviešu valoda 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II LT = lietuvių kalba 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II HU = magyar 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II MT = Malti 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II NL = Nederlands 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II PL = polski 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II PT = português 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II RO = română 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II SK = slovenčina 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II SL = slovenščina 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II FI = suomi 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex II SV = svenska 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III BG = bălgarski 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III ES = español 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III CS = čeština 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III DA = dansk 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III DE = Deutsch 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III ET = eesti keel 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III EL = elliniká 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III EN = English 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III FR = français 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III IT = italiano 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III LV = latviešu valoda 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III LT = lietuvių kalba 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III HU = magyar 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III MT = Malti 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III NL = Nederlands 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III PL = polski 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III PT = português 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III RO = română 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III SK = slovenčina 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III SL = slovenščina 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III FI = suomi 24/01/2013  
Mometasone Furoate Sandoz - Article-29(4) referral - Annex III SV = svenska 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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

More information on Mometasone Furoate Sandoz