Octegra - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Octegra solution for infusion. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Octegra solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely France and Portugal. However, the prescribing information for Octegra solution for infusion should be amended in all the Member States where it is authorised.

The review was carried out under an 'Article 29' referral¹.

A European Commission decision on this opinion will be issued in due course.

¹ Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health

What is Octegra solution for infusion?

Octegra solution for infusion is an antibiotic given by infusion (drip into a vein). It can be used to treat the following bacterial infections:

• community-acquired pneumonia (an infection of the lungs that is caught outside of hospital);
• complicated infections of the skin and the soft tissues below the skin. Complicated means that the infection is difficult to treat because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.

The active substance in Octegra solution for infusion, moxifloxacin, belongs to the group 'fluoroquinolones'. It works by blocking enzymes that bacteria use to make more DNA. By doing this, it stops the bacteria from growing and multiplying.

Why was Octegra solution for infusion reviewed?

Bayer Vital GmbH submitted Octegra solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002. The company wanted the authorisation to be recognised in France and Portugal (the 'concerned Member States'). However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 10 October 2008.

The grounds for the referral were concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Octegra solution for infusion outweigh its risks, and therefore the marketing authorisation for Octegra solution for infusion should be granted in all concerned Member States. The CHMP also recommended that the product information for the medicine should be amended in all the Member States where it is authorised.

The European Commission issued a decision on 2 October 2009.

Questions and answers on the referral for Octegra solution for infusion containing moxifloxacin 400 mg/250 ml

AdoptedReference Number: EMEA/CHMP/150525/2009

Key facts

About this medicine

• Approved name:
  Octegra
• International non-proprietary name (INN) or common name:
  moxifloxacin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/150525/2009
• 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:
  19/03/2009
• EC decision date:
  02/10/2009

All documents

Questions and answers on the referral for Octegra solution for infusion containing moxifloxacin 400 mg/250 ml

AdoptedReference Number: EMEA/CHMP/150525/2009

European Commission final decision

Octegra Article-29(4) referral - Annex I, II and III

Adopted

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.