Ceftriaxone Tyrol Pharma - referral

Current status

European Commission final decision

Overview

Ceftriaxone Tyrol Pharma and associated names, 1g and 2 g powder for solution for injection/infusion, is an antibiotic, being a third generation cephalosporin. It is indicated for the treatment of the following infections when caused by micro-organisms that are susceptible to ceftriaxone and if parenteral treatment is necessary:

• sepsis
• bacterial meningitis
• infections of bones or joints
• infections of skin or soft tissues
• pneumonia

Ceftriaxone is indicated for perioperative prophylaxis in patients with a certain risk of severe postoperative infections. Depending on the mode of surgery and the expected spectrum of pathogens ceftriaxone should be combined with an appropriate antimicrobial agent with additional anaerobic coverage.

Sandoz GmbH submitted applications for mutual recognition of Ceftriaxone Tyrol Pharma and associated names, 1g and 2g, solution for injection/infusion on the basis of the marketing authorisation granted by Germany on 13 August 2002. The Mutual Recognition Procedure started on 24 March 2005. The Reference Member State was Germany and the Concerned Member States were Finland and the United Kingdom. These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. The United Kingdom referred the reasons for disagreement to the EMEA on 16 August 2005.

Significant difference has been identified with regard to the proposed SPC compared to the SPC of the reference product in the UK. This refers to the dosing recommendation for the newborn and this was considered to be of serious public health concern. The posology in neonates where higher doses were proposed for neonates aged 15-27 days (80 mg/kg) while the standard dose is 20-50mg/kg in the UK for neonates 0-28 days.

The arbitration procedure started on 15 September 2005 with the adoption of a list of questions. The Rapporteur was Dr. Broich and Co-Rapporteurs were Dr. Hudson and Dr. Kuitunen. The Marketing Authorisation Holder provided written explanations on 28 November 2005.

During their May 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ceftriaxone Tyrol Pharma and associated names, that the objections raised by United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. A positive opinion was adopted by majority on 1 June 2006.

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 21 August 2006.

Opinion following an Article 29(2) referral for Ceftriaxone Tyrol Pharma and associated names International Non-Proprietary Name (INN): Ceftriaxone: Background information

AdoptedReference Number: EMEA/CHMP/212746/2006

Key facts

About this medicine

• Approved name:
  Ceftriaxone Tyrol Pharma
• International non-proprietary name (INN) or common name:
  Ceftriaxone

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/212746/06
• 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:
  01/06/2006
• EC decision date:
  21/08/2006

All documents

Ceftriaxone Tyrol Pharma - Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(2) referral for Ceftriaxone Tyrol Pharma and associated names International Non-Proprietary Name (INN): Ceftriaxone: Background information

AdoptedReference Number: EMEA/CHMP/212746/2006

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.