Sabumalin - referral

Current status

European Commission final decision

Overview

The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sabumalin. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Sabumalin outweigh its risks, and that the marketing authorisation can be granted in Sweden as well as in the following Member States of the European Union: Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom.
The review was carried out under an 'Article 29' referral¹.

The European Commission issued a decision on 12 March 2009.

¹ Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health

What is Sabumalin?

Sabumalin is a medicine in a pressurised inhaler that contains salbutamol as active substance. Salbutamol is a beta2-adrenergic receptor agonist. This means that salbutamol activates the beta2-receptors in the body. When given by inhalation as in Sabumalin, salbutamol directly activates the beta2-receptors in the respiratory system. This makes the airways widen, allowing the air to flow more freely.

Sabumalin is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD). It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke. Sabumalin is used to relieve symptoms, and its use should not delay the use of inhaled steroids. Sabumalin is a 'generic medicine'. This means that Sabumalin is similar to a 'reference medicine' already authorised in the European Union (EU) called Sultanol inhaler.

Why was Sabumalin reviewed?

Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006. This is a procedure when one Member State (the 'reference Member State', in this instance Sweden) assesses a medicine with a view of 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, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom). These member states were not able to reach an agreement. On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.

The grounds for the referral were concerns regarding that there was not enough data showing that Sabumalin is equivalent to the reference medicine. Concerns were also raised regarding how to store the inhaler and the effect of the orientation of the inhaler on the delivery of the medicine.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sabumalin outweigh its risks, and that therefore the marketing authorisation for Sabumalin should be granted in all concerned member states.

Questions and answers on the referral for Sabumalin salbutamol, metered dose aerosol inhaler, 100 μg/dose

Adopted Reference Number: EMEA/CHMP/194784/2009

Key facts

About this medicine

• Approved name:
  Sabumalin
• International non-proprietary name (INN) or common name:
  salbutamol

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/194784/2009
• 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:
  19/12/2008
• EC decision date:
  12/03/2009

All documents

Sabumalin - Article 29 referral - Annex I, II, III

Adopted

Questions and answers on the referral for Sabumalin salbutamol, metered dose aerosol inhaler, 100 μg/dose

Adopted Reference Number: EMEA/CHMP/194784/2009

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.