Betavert N - 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 Betavert N. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Betavert N outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the European Union.

The European Commission issued a decision on 2 June 2009.

What is Betavert N?

Betavert N is used to treat patients with Menière's disease. Menière's disease is a disease where an accumulation of fluid in the inner ear causes a build-up of pressure. Patients with Menière's disease have vertigo (a spinning sensation), often associated with feeling sick or vomiting, tinnitus (ringing in the ear) and hearing loss.

The active substance in Betavert N, betahistine, is an analogue of histamine, a naturally-occurring substance in the body that is involved in many processes. In Menière's disease, betahistine is thought to attach to some receptors to which histamine normally attaches. This allows a dilation of the blood vessels in the inner ear, thus helping the pressure to drop and relieving the symptoms of the disease.

Betavert N is a 'generic medicine'. This means that Betavert N is similar to a 'reference medicine' already authorised in the European Union (EU) called Betaserc 8.

Why was Betavert N reviewed?

Hennig Arzneimittel GmbH & Co. KG submitted Betavert N for mutual recognition on the basis of the initial authorisation granted by Germany on 18 April 2007. The company wanted the authorisation to be recognised in Austria, Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia (the concerned Member States).

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 30 October 2008.

The grounds for the referral were concerns expressed by the Czech Republic that Betavert N had not been shown to be bioequivalent to Betaserc 8. Medicines are bioequivalent when they produce the same levels of active substance in the body.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Betavert N and Betaserc 8 had been demonstrated. The CHMP therefore concluded that Betavert N could be considered a generic medicine of Betaserc 8, and the marketing authorisation for Betavert N should be granted in all concerned Member States.

Questions and answers on the referral for Betavert N tablets containing betahistine dihydrochloride (8 or 16 mg)

Adopted Reference Number: EMEA/403687/2009

Key facts

About this medicine

• Approved name:
  Betavert N
• International non-proprietary name (INN) or common name:
  betahistine dihydrochloride

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1094
• 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:
  20/03/2009
• EC decision date:
  02/06/2009

All documents

Betavert N - Article 29 referral - Annex I, II, III

Adopted

Questions and answers on the referral for Betavert N tablets containing betahistine dihydrochloride (8 or 16 mg)

Adopted Reference Number: EMEA/403687/2009

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.