Clenil and associated names - referral

Current status

European Commission final decision

Overview

 

Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension)

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

On 15 September 2016, the European Medicines Agency completed a review of Clenil. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Clenil in the European Union (EU).

What is Clenil?

Clenil is a medicine used for the maintenance treatment of asthma in adults and children. It is also used to treat recurrent wheezing (whistling sound made while breathing, caused by narrowed airways or inflammation) in children up to 5 years of age. It is available as a suspension given by inhalation though a nebuliser device, and in asthma it should only be used when the use of other hand-held inhalers is not appropriate.

Clenil contains the active substance beclometasone dipropionate (which belongs to a group of anti-inflammatory medicines commonly known as 'corticosteroids').

Clenil is marketed in the following EU Member States: France, Germany, Greece, Ireland and Italy. It is also available under the trade names of Becloneb, Beclospin and Sanasthmax. The company that markets these medicines is Chiesi and associated companies.

Why was Clenil reviewed?

Clenil 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 the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Clenil was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

On 19 June 2015, the Italian medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for Clenil and associated names 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 should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP agreed that Clenil can be used for the maintenance treatment of asthma in adults and children when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate.

The Committee agreed that Clenil should no longer be used to treat common bronchostenotic conditions (narrowing of the airways in the lungs) because of the lack of rigorous evidence from adequately designed clinical studies. However, the Committee considered that Clenil can be used to treat recurrent wheezing in children up to 5 years of age because this use is supported by adequate data.

The CHMP also agreed that Clenil should no longer be used to treat allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites) because the available data do not support this use and other medicines available as nasal sprays may be better tolerated.

4.2 Posology and method of administration

Having harmonised the indication, the CHMP also harmonised recommendations on the doses. The starting dose of Clenil depends on the frequency and severity of symptoms and it can be adjusted until symptoms are under control. The maximum daily dose is 3,200 micrograms in adults and adolescents (up to 1,600 micrograms taken twice a day) and 1,600 micrograms in children below 12 years (up to 800 micrograms taken twice a day). The lowest dose needed to control symptoms should be used.

In children with recurrent wheezing the response to treatment should be carefully monitored; if no benefit is observed within 2-3 months, Clenil should be discontinued. The duration of treatment should not exceed 3 months, unless a diagnosis of asthma is likely.

4.4 Special warnings and precautions for use

In children up to 5 years of age, the decision to start Clenil for the treatment of recurrent wheezing should be determined by the severity and frequency of the wheezing episodes. Regular follow-up is recommended to review the treatment response. If no treatment benefit is observed within 2-3 months or if a diagnosis of asthma is not likely, Clenil should be discontinued to avoid unnecessary long-term exposure to inhaled corticosteroids and associated risks in children.

Other changes

The Committee also harmonised other sections of the SmPC including sections 4.6 (fertility, pregnancy and lactation), 4.8 (side effects), and 5.1 (pharmacodynamics).

The amended information to doctors and patients is available here.

The European Commission issued a decision on this opinion on 11/11/2016.

Clenil Article-30 referral - Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension)

Reference Number: EMA/612121/2016

Key facts

About this medicine

• Approved name:
  Clenil and associated names
• International non-proprietary name (INN) or common name:
  beclometasone dipropionate
• Associated names:
  • Becloneb
  • Beclospin and Sanasthmax

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1418
• 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:
  15/09/2016
• EC decision date:
  11/11/2016

All documents

Opinion provided by Committee for Medicinal Products for human Use

Clenil Article-30 referral - Annex III

Clenil Article-30 referral - Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension)

Reference Number: EMA/612121/2016

European Commission final decision

Clenil Article-30 referral - CHMP Assessment report

AdoptedReference Number: EMA/635512/2016

Clenil Article-30 referral - Annex I

Clenil 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.