Ciprofloxacin Nycomed

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Ciprofloxacin Nycomed and associated names, 2 mg/ml Solution for Infusion, is an antibiotic belonging to the quinolone family effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.

Nycomed Danmark ApS submitted applications for mutual recognition of Ciprofloxacin Nycomed and associated names, 2 mg/ml Solution for Infusion, on the basis of the marketing authorisation granted by United Kingdom on 23 March 2005. The Mutual Recognition Procedure started on 15 November 2005. The Reference Member State was United Kingdom and the Concerned Member States were Denmark, Finland, Norway and Sweden. These Member States were not able to reach an agreement with respect to the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. United Kingdom referred the reasons for disagreement to the EMEA on 5 May 2006.

Significant differences were identified with regards to the approved posology for complicated urinary tract infections and the maximum daily dose for this generic intravenous ciprofloxacin product. These issues were considered to be of serious public health concern. The proposed dosage regimen for complicated urinary tract infections (100 mg bid) was considered too low and should be changed to 200-400 mg twice daily. Further, as patients referred to parenteral treatment often are seriously ill, it was felt of importance that a maximum dosage of 1200 mg (400 mg three times daily) instead of 800 mg be permitted.

The arbitration procedure started on 1 June 2006 with the adoption of a list of questions. The Rapporteur was Dr Hudson and Co-Rapporteur(s) was Dr Ljungberg. The Marketing Authorisation Holder provided written explanations on 21 September 2006.

During their 13-16 November 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 Ciprofloxacin Nycomed and associated names, that the objections raised by Norway and Sweden 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 consensus on 16 November 2006. On 21 June 2007 the CHMP, in order to focus and facilitate the translations of the specific amendments in the Summary of Product Characteristics, adopted a revised opinion with amended Annex II and Annex III, which was further reconsidered in October 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 18 January 2008.

Key facts

Approved name
Ciprofloxacin Nycomed
International non-proprietary name (INN) or common name

Ciprofloxacin

Reference number
CHMP/350278/07
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.

Status
European Commission final decision
Opinion date
17/11/2006
EC decision date
18/01/2008

All documents

Document description

  • 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

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