Gluscan 500 - referral

Current status

European Commission final decision

Overview

The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Gluscan 500. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Gluscan 500 outweigh its risks, and the marketing authorisation can be granted in France and in the following Member States of the European Union Germany, Poland, Portugal and Spain.
The review was carried out under an 'Article 29' referral¹.

The European Commission issued a decision on 29 May 2009.

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

What is Gluscan 500?

The active substance in Gluscan 500, fluodeoxyglucose (¹⁸F), is a diagnostic radiopharmaceutical. It contains a substance, fluodeoxyglucose, that has been labelled with ¹⁸F (fluoride-18), a radioactive form of the chemical element fluorine. When Gluscan 500 is injected in the body, the radiolabelled fluodeoxyglucose is absorbed in the same way as glucose, the main source of energy for the cells. This means that it will be absorbed differently by cells depending on their state.

Once in the cell, the radioactivity remains trapped, and can be seen on scans such as those obtained using a 'PET' (positron emission tomography) scanner.

Gluscan 500 can be used:

• in cancer medicine to help detect the location of tumours, as cancer cells use a lot of energy and will absorb more fluodeoxyglucose than non-cancerous cells;
• in cardiac medicine to help locate areas of the heart that are not taking up as much glucose as expected because of ischaemia (reduced blood supply);
• in neurology to detect specific areas within the brain of epileptic patients before surgery;
• and to locate areas of the body where there are abnormally high numbers of white blood cells (such as the sites of deep-seated infections or inflammation).

Why was Gluscan 500 reviewed?

Advanced Accelerator Applications submitted Gluscan 500 to the French medicines regulatory agency for a decentralised procedure. This is a procedure when one Member State (the 'reference Member State', in this instance France) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the 'concerned Member States', in this instance are Germany, Poland, Portugal and Spain)².

However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 30 January 2009.

The grounds for the referral were concerns from the Spanish medicines regulatory agency that, while the use of fluodeoxyglucose (18F) with PET in the areas of cancer, cardiac and neurology medicine were well established, its use in the diagnosis of infectious and inflammatory conditions had not been shown to be sufficiently established in the European Union, and therefore the use of Gluscan 500 as a diagnostic radiopharmaceutical in the diagnosis of these conditions should not be authorised.

² Fluodeoxyglucose (18F) is already authorised via national procedures in the Czech Republic, Ireland and the United Kingdom

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Gluscan 500 outweigh its risks, and therefore the marketing authorisation for Gluscan 500 should be granted in all concerned Member States.

Questions and answers on the referral for Gluscan 500 solution for injection containing fludeoxyglucose (18F) 500MBq per ml

Adopted Reference Number: EMEA/CHMP/342694/2009

Key facts

About this medicine

• Approved name:
  Gluscan 500
• International non-proprietary name (INN) or common name:
  fludeoxyglucose (18F)

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1123
• 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:
  20/03/2009
• EC decision date:
  29/05/2009

All documents

Gluscan 500 - Article 29 referral - Annex I, II, III

Adopted

Questions and answers on the referral for Gluscan 500 solution for injection containing fludeoxyglucose (18F) 500MBq per ml

Adopted Reference Number: EMEA/CHMP/342694/2009

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.