Cefuroximaxetil - referral

Current status

European Commission final decision

Overview

Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets is a cephalosporin ([Beta] - lactam group of antibiotics), indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:

• upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
• acute bronchitis, acute exacerbations of chronic bronchitis
• lower uncomplicated urinary tract infections: cystitis
• skin and soft tissue infections: furunculosis, pyoderma and impetigo
• uncomplicated gonorrhoea: urethritis and cervicitis
• treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and children above 12 years of age.

Sandoz B.V. submitted applications for mutual recognition of Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets on the basis of the marketing authorisation granted by the Netherlands on 1 October 2004. The repeat-use Mutual Recognition Procedure started on 17 May 2006. The Reference Member State was the Netherlands and the Concerned Member States were Estonia, Greece, Portugal and Spain. These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. Spain referred the reasons for disagreement to the EMEA on 25 September 2006.

Significant difference was identified with regard to the indication “uncomplicated gonorrhoea: urethritis and cervicitis”. This refers to the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and riskbenefit balance for this sought indication and this was considered to be a serious public health concern. The arbitration procedure started on 18 October 2006 with the adoption of a list of questions. The Rapporteur was Dr Frits Lekkerkerker and Co-Rapporteur was Dr Gonzalo Calvo Rojas. The Marketing Authorisation Holder provided written explanations on 15 January 2007.

During their April 2007 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 raised by Spain could be agreed and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications should be granted to include these amendments. An opinion was adopted by consensus on 26 April 2007.

The list of the 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 final opinion was converted into a Decision by the European Commission on 22 August 2007.

Opinion following an Article 29(4) referral for Cefuroximaxetil and associated names International Non-Proprietary Name (INN): cefuroxime (as axetil): Background information

Adopted Reference Number: EMEA/CHMP/248862/2007

Key facts

About this medicine

• Approved name:
  Cefuroximaxetil
• International non-proprietary name (INN) or common name:
  cefuroxime (as axetil)

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/248862/07
• 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:
  26/04/2007
• EC decision date:
  22/08/2007

All documents

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

Adopted

Opinion following an Article 29(4) referral for Cefuroximaxetil and associated names International Non-Proprietary Name (INN): cefuroxime (as axetil): Background information

Adopted Reference Number: EMEA/CHMP/248862/2007

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.