Prevora - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Prevora. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Prevora outweigh its risks, and the marketing authorisation granted in Ireland can be recognised in other Member States of the EU.

What is Prevora?

Prevora is a dental solution used to reduce dental caries (tooth decay) in permanent teeth of adolescents and adults. The active substance in Prevora, chlorhexidine, is an antiseptic. It works by disrupting the membrane of bacteria, fungi and other organisms, blocking their growth.

Prevora is applied to the surface of permanent teeth by a dental professional in two stages. First a chlorhexidine coating solution is applied followed immediately by an inert sealant coating.

Why was Prevora reviewed?

CHX Technologies Europe Limited submitted Prevora for mutual recognition on the basis of the initial authorisation granted by Ireland on 5 May 2006. The company wanted the authorisation to be recognised in United Kingdom (the 'concerned Member State').

However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 26 November 2009.

The grounds for the referral were that the United Kingdom could not approve the proposed indication, prevention of root caries in adult patients at high-risk of dental caries. The United Kingdom had concerns that the results from the main study with Prevora were not sufficient to support the proposed indication, and that another study was needed to confirm the results seen to date with the medicine.

What are the conclusions of the CHMP?

Based on evaluation of the newly available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Prevora outweigh its risks in the prevention of coronal and root caries in adult patients at high-risk of dental caries. Therefore the marketing authorisation for Prevora should be granted in the United Kingdom.

The amended information to healthcare professionals and patients is available in the 'All documents' tab.

The European Commission issued a decision on 03 December 2010

Questions and answers on Prevora (chlorhexidine diacetate, 100 mg/ml dental solution)

Key facts

About this medicine

• Approved name:
  Prevora
• International non-proprietary name (INN) or common name:
  chlorhexidine diacetate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1258
• 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:
  23/09/2010
• EC decision date:
  03/12/2010

All documents

Prevora - Article 29 referral - Annex I

Prevora - Article 29 referral - Annex II

Prevora - Article 29 referral - Annex III

Questions and answers on Prevora (chlorhexidine diacetate, 100 mg/ml dental solution)

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.