Ciprofloxacin Nycomed - referral

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.

Opinion following an Article 29(4) referral for Ciprofloxacin Nycomed and associated names International Non-Proprietary Name (INN): Ciprofloxacin: Background information

Adopted Reference Number: EMEA/CHMP/350278/2007

Key facts

About this medicine

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

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  17/11/2006
• EC decision date:
  18/01/2008

All documents

Ciprofloxacin Nycomed - Article 29 referral - Annex I, II, III

Adopted

Opinion following an Article 29(4) referral for Ciprofloxacin Nycomed and associated names International Non-Proprietary Name (INN): Ciprofloxacin: Background information

Adopted Reference Number: EMEA/CHMP/350278/2007

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.