Durogesic and associated names - referral

Current status

European Commission final decision

Overview

On 21 July 2016, the European Medicines Agency completed a review of Durogesic. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Durogesic in the European Union (EU).

What is Durogesic?

Durogesic is a medicine used to relieve severe long-term pain in adults and children from 2 years of age. It contains the active substance fentanyl and is available as a transdermal patch (a patch that gradually delivers the medicine through the skin). Fentanyl is an opioid (a pain medicine related to morphine).

Durogesic is available in the EU under various trade names including Durogesic DTrans and Durogesic Matrix. The company that markets these medicines is Janssen-Cilag and associated companies.

Why was Durogesic reviewed?

Durogesic has been authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Durogesic was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).¹

On 15 September 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Durogesic in the EU.²

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¹The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.

²This referral procedure did not cover other fentanyl formulations such as tablets, nasal sprays or solutions for injection.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP agreed that Durogesic can be used in adults to treat severe long-term pain that requires continuous treatment with opioid medicines, whether or not the pain is caused by cancer. Durogesic can also be used to treat severe long-term pain in children from 2 years of age who are already being treated with opioids.

4.2 Posology and method of administration

Having harmonised the indication, the CHMP also harmonised the recommendations on how to use Durogesic. The appropriate starting dose should be chosen according to the patient's current use of opioid medicines. The age and general condition of the patient should also be taken into account. The dose should be re-assessed regularly during treatment and the lowest effective dose should be used. The patch should be replaced every 3 days.

Tables to work out the appropriate dose of Durogesic when switching from other opioids taken by mouth or given by injection have been included in the harmonised SmPC.

The use of Durogesic is not recommended in patients who have not taken opioid medicines before. However, adult patients who cannot take opioids by mouth and for whom Durogesic is considered the only option could be given the patch with the lowest dose. These patients should be closely monitored for side effects.

4.3 Contra-indications

Durogesic must not be used to relieve severe short-term pain or pain resulting from an operation. Also, it must not be used in patients with severe respiratory depression (breathing problems), or in those allergic to fentanyl or any other ingredients of Durogesic.

4.4 Special warnings and precautions for use

Patients who have serious side effects with Durogesic should be monitored for at least 24 hours after removal of the patch, depending on their symptoms, because the active substance fentanyl remains in the blood for some time and its level only declines slowly (by about half after 24 hours).

Durogesic patches release enough fentanyl to be fatal if not used appropriately, especially for a child; sufficient fentanyl remains in the patch to cause severe effects even after it has been used. Therefore, the patches must be kept out of the sight and reach of children, before and after use. In children treated with Durogesic, the patch should be applied on the upper back to prevent the child from removing the patch.

This section also contains other warnings, including warnings about the risk of respiratory depression, dependence and potential for abuse, and use in children and elderly patients.

Other changes

The Committee also harmonised other sections of the SmPC including sections 4.6 (fertility, pregnancy and lactation), 4.8 (side effects), and 4.9 (overdose).

The amended Durogesic Article-30 referral - Annex III is available.

The European Commission issued a decision on this opinion on 22/09/16.

Durogesic Article-30 referral - Questions and answers on Durogesic and associated names (fentanyl transdermal patches)

Reference Number: EMA/491912/2016 Rev.1 Summary:

Outcome of a procedure under Article 30 of Directive 2001/83/EC

Key facts

About this medicine

• Approved name:
  Durogesic and associated names
• International non-proprietary name (INN) or common name:
  fentanyl

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1413
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  21/07/2016
• EC decision date:
  22/09/2016

All documents

Opinion provided by Committee for Medicinal Products for human Use

Durogesic Article-30 referral - Annex I

Durogesic Article-30 referral - Annex II

Durogesic Article-30 referral - Assessment report

Adopted Reference Number: EMA/641560/2016

Durogesic Article-30 referral - Annex III

Reference Number: EMEA/H/A-30/1413

Durogesic Article-30 referral - Questions and answers on Durogesic and associated names (fentanyl transdermal patches)

Reference Number: EMA/491912/2016 Rev.1 Summary:

Outcome of a procedure under Article 30 of Directive 2001/83/EC

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.