Nasonex - referral

Current status

European Commission final decision

Overview

On 20 November 2014, the European Medicines Agency completed a review of Nasonex and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Nasonex and associated names in the European Union (EU).

What is Nasonex?

Nasonex is an anti-inflammatory medicine that is used in adults and children from three years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by occasional or long-term allergy). In addition, it is used in adults to treat nasal polyps (growths in the lining of the nose).

Nasonex contains the active substance mometasone furoate. It is available as a nasal spray. Nasonex and associated names have been authorised in EU Member States through national procedures since 1997.

Nasonex and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus1, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.

The company that markets these medicines is Merck Sharp & Dohme.

Why was Nasonex reviewed?

As Nasonex has been authorised in the EU via national procedures, this has led to divergences across Member States in the way the medicine can be used, as seen in differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

In view of this, on 17 September 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Nasonex in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets for Nasonex should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

After reviewing the available data supporting the medicine's use, the CHMP agreed that Nasonex can be used for the following:

• Treatment of symptoms of seasonal allergic or perennial rhinitis in adults and in children aged three and above.
• Treatment of nasal polyps in adults (aged 18 years and older).

The Committee also agreed that Nasonex should no longer be recommended to treat acute sinusitis, which was authorised in some Member States, because the available data to support this use were considered limited.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised recommendations on the doses.

4.3 Contraindications

The CHMP agreed to that Nasonex must not be used in:

• Patients with known hypersensitivity (allergy) to mometasone furoate or to any other ingredients.
• Patients who have an untreated and localised infection, such as herpes, affecting the inside of the nose.
• Patients who have recently undergone nose surgery or who have a wound in the nose, because Nasonex can affect wound healing.

Other changes

The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), 4.8 (side effects) and 5.1 (pharmacodynamic properties). The labelling and package leaflet were also revised in line with the changes to the SmPC.

The amended information to doctors and patients is available under the 'All documents' tab.

The European Commission issued an EU-wide legally binding decision to implement these changes on 19 January 2015.

Questions and answers on Nasonex and associated names (mometasone furoate, 50 microgram, nasal spray)

Reference Number: EMA/707071/2014 Summary:

Outcome of a procedure under Article 30 of Directive 2001/83/EC

Key facts

About this medicine

• Approved name:
  Nasonex
• International non-proprietary name (INN) or common name:
  mometasone furoate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1374
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  20/11/2014
• EC decision date:
  19/01/2015

All documents

Procedure started

Nasonex Article-30 referral - Annex III

Questions and answers on Nasonex and associated names (mometasone furoate, 50 microgram, nasal spray)

Reference Number: EMA/707071/2014 Summary:

Outcome of a procedure under Article 30 of Directive 2001/83/EC

European Commission final decision

Nasonex Article-30 referral - Assessment report

Reference Number: EMA/37163/2015

Nasonex Article-30 referral - Annex I

Nasonex Article-30 referral - Annex II

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.