Budesonide Sandoz - referral

Current status

European Commission final decision

Overview

The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Budesonide Sandoz. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Budesonide Sandoz outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the European Union, the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom.
The review was carried out under an 'Article 29' referral¹.

The European Commission issued a decision on 7 May 2009.

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

What is Budesonide Sandoz?

Budesonide Sandoz is an anti-inflammatory medicine. It is used to treat and prevent the symptoms of seasonal allergic rhinitis (allergy to pollen, also known as hayfever) and perennial allergic rhinitis (when the allergy is due to other triggers, such as house dust or animals). It can also be used to treat nasal polyps (growths in the lining of the nose).

The active substance, budesonide, is a corticosteroid, which is a type of substance that helps to reduce inflammation.

Budesonide Sandoz is almost identical to another medicine authorised in the European Union, Rhinocort. The only difference is that it contains very small amounts of ascorbic acid (an antioxidant).

Why was Budesonide Sandoz reviewed?

Sandoz Pharmaceuticals GmbH submitted Budesonide Sandoz to the German medicines regulatory agency for a decentralised procedure. This is a procedure when one Member State (the 'reference Member State', in this instance Germany) 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 the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom). However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 4 August 2008.

The grounds for the referral were a disagreement among Member States on the use of the medicine in adolescents and children (over 6 years of age). The German authorities recommended that the medicine should not be authorised for use in children, as no studies had been carried out in this age group. However, another Member State, the Netherlands, recommended that the medicine should also be authorised for use in children, as the medicine on which it is based, Rhinocort, can be used in this population.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data, including the studies carried out to compare the way Budesonide Sandoz is handled by the body to that of Rhinocort, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Budesonide Sandoz outweigh its risks, and that therefore the marketing authorisation for Budesonide Sandoz should be granted in all concerned Member States for patients aged from 6 years. The CHMP also recommended that the product information for the medicine in Germany be amended.

The amended information to healthcare professionals and patients is available under the "All documents" tabs.

Questions and answers on the referral for Budesonide Sandoz nasal suspension with 32 or 64 microgram per spray

Adopted Reference Number: EMEA/CHMP/259505/2009

Key facts

About this medicine

• Approved name:
  Budesonide Sandoz
• International non-proprietary name (INN) or common name:
  budesonide

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1062
• 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:
  20/02/2009
• EC decision date:
  07/05/2009

All documents

Budesonide Sandoz - Article 29 referral - Annex I, II, III

Adopted

Questions and answers on the referral for Budesonide Sandoz nasal suspension with 32 or 64 microgram per spray

Adopted Reference Number: EMEA/CHMP/259505/2009

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.