Oracea - referral

Current status

European Commission final decision

Overview

Oracea, 40 mg, modified release capsules is an antibiotic (doxycycline), indicated for the reduction of papulopustular lesions in adult patients with facial rosacea.

The applicant FGK Representative Service GmbH submitted an application for Marketing Authorisation Application of Oracea, 40 mg, modified release capsule on the basis of the marketing application to the UK on 28 February 2006. The Decentralised Procedure UK/H/0892/01/DC started on 12 April 2006. The Reference Member State was United Kingdom and the Concerned Member States were Austria, Germany, Finland, Ireland, Italy, Luxembourg, Netherlands and Sweden.

These Member States were not able to reach an agreement and therefore the United Kingdom referred the reasons for disagreement to the CHMP on 27 July 2007.

Significant difference had been identified with regard to the lack of sufficient safety and efficacy evidence, the emergence of bacterial resistance caused by the use of Oracea and the insufficient demonstration of a positive benefit: risk ratio. These issues were considered to be of serious public health concern.

The arbitration procedure started on 20 September 2007 with the adoption of a List of Questions. The Rapporteur was Dr Tomas Salmonson (SE) and Co Rapporteur was Dr Ian Hudson (UK). The Applicant provided written explanations on 30 November 2007 and on 3 March 2008.

During their April 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral should not prevent the granting of a Marketing Authorisation for Oracea and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. A positive opinion was therefore adopted by consensus on 24 April 2008 and the grounds for opinion, the conditions of the Marketing Authorisation and the amended SPC, labelling and package leaflet of the relevant Member State were annexed.

The list of the medicinal product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III. The conditions of the Marketing Authorisation are provided in Annex IV.

The final opinion was converted into a Decision by the European Commission on 22 July 2008.

Opinion following an Article 29(4) referral for Oracea International Non-Proprietary Name (INN): doxycycline monohydrate: Background information

Adopted Reference Number: EMEA/CHMP/428671/2008

Key facts

About this medicine

• Approved name:
  Oracea
• International non-proprietary name (INN) or common name:
  doxycycline monohydrate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/428671/08
• 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:
  24/04/2008
• EC decision date:
  22/07/2008

All documents

Oracea - Article 29 referral - Annex I, II, III, IV

Adopted

Opinion following an Article 29(4) referral for Oracea International Non-Proprietary Name (INN): doxycycline monohydrate: Background information

Adopted Reference Number: EMEA/CHMP/428671/2008

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.