Mometasone Furoate Sandoz - referral

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.

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.

Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose)

Reference Number: EMA/476365/2012Summary:

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.

Key facts

About this medicine

• 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

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  19/07/2012
• EC decision date:
  08/10/2012

All documents

Questions and answers on Mometasone Furoate Sandoz (mometasone furoate nasal spray, 50 microgram/dose)

Reference Number: EMA/476365/2012Summary:

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.

European Commission final decision

Mometasone Furoate Sandoz - Article-29(4) referral - Assessment report

AdoptedReference Number: EMA/CHMP/573035/2012

Mometasone Furoate Sandoz - Article-29(4) referral - Annex I

Mometasone Furoate Sandoz - Article-29(4) referral - Annex II

Mometasone Furoate Sandoz - Article-29(4) referral - Annex III

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.