Ceftriaxone Tyrol Pharma
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
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:
- bacterial meningitis
- infections of bones or joints
- infections of skin or soft tissues
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.
Ceftriaxone Tyrol Pharma
|International non-proprietary name (INN) or common name||
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.
European Commission final decision
|EC decision date||
Opinion following an Article 29(2) referral for Ceftriaxone Tyrol Pharma and associated names International Non-Proprietary Name (INN): Ceftriaxone: Background information (PDF/34.16 KB)Adopted
First published: 21/08/2006
Last updated: 21/08/2006
Ceftriaxone Tyrol Pharma - Article 29 referral - Annex I, II, III (PDF/154.48 KB)Adopted
First published: 30/08/2006
Last updated: 30/08/2006
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies