Dexamed and associated names

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On 22 May 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamed (dexamfetamine sulphate). The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Dexamed outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following countries: Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain and Sweden.

What is Dexamed?

Dexamed is a medicine that contains the active substance dexamfetamine sulphate. It is to be available as tablets (5 mg) for the treatment of children between 6 and 17 years of age who have attention deficit hyperactivity disorder (ADHD) and in whom methylphenidate (another medicine for ADHD) was not effective (second-line treatment). ADHD is a condition that mainly affects children, resulting in a persistent inability to concentrate, hyperactivity and impulsive behaviour.

Dexamfetamine belongs to a group of medicines called ‘psychostimulants’ and is thought to work by activating certain areas of the brain that control attention and concentration, thus helping to reduce impulsive behaviour.

Why was Dexamed reviewed?

Kohne Pharma GmbH submitted Dexamed to the UK medicines regulatory agency for a decentralised procedure. This is a procedure where one European country (the ‘reference Member State’, in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other European countries (the ‘concerned Member States’, in this instance Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain, and Sweden).

However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 10 June 2013.

The grounds for the referral were concerns raised by the Netherlands that Dexamed presents a higher risk for abuse and dependence compared with other ADHD treatments, and that the data submitted to support the application did not provide sufficient evidence to demonstrate its effectiveness as a second-line treatment for ADHD.

What are the conclusions of the CHMP?

Although the CHMP acknowledged that there is a risk of abuse and dependence with Dexamed, it concluded that the risk minimisation measures proposed to mitigate this risk are adequate. These conclusions were supported by a group of experts in childhood and adolescent behavioural problems consulted by the CHMP. The experts’ group advised that while there is some evidence that medicines of the same type as Dexamed are more likely to induce dependence than other treatments for ADHD, based on clinical practice the risk of developing dependence in patients treated with dexamfetamine is considered to be low and could be adequately managed with appropriate risk minimisation measures.

These measures include starting and regularly monitoring treatment with Dexamed under the supervision of a doctor experienced in treating childhood and adolescent behaviour disorders. Educational material will be provided to doctors to help them decide if treatment with Dexamed is appropriate and to monitor patients receiving the medicine. Educational material will also be given to pharmacists, parents and carers to help them identify any potential abuse or improper use of Dexamed. Furthermore, the company that markets Dexamed will conduct additional studies on the risk of abuse for this medicine.

The CHMP also noted that evidence from studies and clinical practice is available to show that dexamfetamine is effective in ADHD, including in patients in whom other treatments have failed.

Therefore, based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Dexamed outweigh its risks for second-line treatment of ADHD and recommended that the marketing authorisation be granted in all concerned Member States.

The European Commission issued a decision on 06 August 2014.

Name Language First published Last updated
Dexamed and associated names Article-29(4) referral - Questions and answers BG = bălgarski 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers ES = español 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers CS = čeština 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers DA = dansk 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers DE = Deutsch 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers ET = eesti keel 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers EL = elliniká 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers EN = English 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers FR = français 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers IT = italiano 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers LV = latviešu valoda 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers LT = lietuvių kalba 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers HU = magyar 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers MT = Malti 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers NL = Nederlands 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers PL = polski 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers PT = português 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers RO = română 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers SK = slovenčina 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers SL = slovenščina 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers FI = suomi 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers SV = svenska 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers HR = Hrvatski 2014-05-23 2014-09-02

Key facts

Approved nameDexamed and associated names
International non-proprietary name (INN) or common name

Dexamfetamine

Associated names
Class
Reference numberEMEA/H/A-29/1375
TypeArticle 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

StatusEuropean Commission final decision
Opinion date22/05/2014

All documents

Name Language First published Last updated
Dexamed and associated names Article-29(4) referral - Questions and answers BG = bălgarski 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers ES = español 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers CS = čeština 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers DA = dansk 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers DE = Deutsch 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers ET = eesti keel 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers EL = elliniká 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers EN = English 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers FR = français 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers IT = italiano 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers LV = latviešu valoda 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers LT = lietuvių kalba 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers HU = magyar 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers MT = Malti 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers NL = Nederlands 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers PL = polski 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers PT = português 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers RO = română 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers SK = slovenčina 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers SL = slovenščina 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers FI = suomi 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers SV = svenska 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Questions and answers HR = Hrvatski 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Assessment report (English only) 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I BG = bălgarski 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I ES = español 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I CS = čeština 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I DA = dansk 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I DE = Deutsch 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I ET = eesti keel 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I EL = elliniká 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I EN = English 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I FR = français 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I IT = italiano 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I LV = latviešu valoda 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I LT = lietuvių kalba 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I HU = magyar 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I MT = Malti 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I NL = Nederlands 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I PL = polski 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I PT = português 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I RO = română 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I SK = slovenčina 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I SL = slovenščina 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I FI = suomi 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I SV = svenska 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I HR = Hrvatski 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex I NO = Norsk 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II BG = bălgarski 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II ES = español 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II CS = čeština 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II DA = dansk 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II DE = Deutsch 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II ET = eesti keel 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II EL = elliniká 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II EN = English 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II FR = français 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II IT = italiano 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II LV = latviešu valoda 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II LT = lietuvių kalba 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II HU = magyar 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II MT = Malti 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II NL = Nederlands 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II PL = polski 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II PT = português 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II RO = română 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II SK = slovenčina 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II SL = slovenščina 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II FI = suomi 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II SV = svenska 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex II HR = Hrvatski 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex III BG = bălgarski 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III ES = español 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III CS = čeština 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III DA = dansk 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III DE = Deutsch 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III ET = eesti keel 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III EL = elliniká 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III EN = English 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III FR = français 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III IT = italiano 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III LV = latviešu valoda 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III LT = lietuvių kalba 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III HU = magyar 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III MT = Malti 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III NL = Nederlands 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III PL = polski 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III PT = português 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III RO = română 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III SK = slovenčina 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III SL = slovenščina 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III FI = suomi 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III SV = svenska 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III HR = Hrvatski 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex III NO = Norsk 2014-05-23 2014-09-02
Dexamed and associated names Article-29(4) referral - Annex IV BG = bălgarski 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV ES = español 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV CS = čeština 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV DA = dansk 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV DE = Deutsch 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV ET = eesti keel 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV EL = elliniká 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV EN = English 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV FR = français 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV IT = italiano 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV LV = latviešu valoda 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV LT = lietuvių kalba 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV HU = magyar 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV MT = Malti 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV NL = Nederlands 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV PL = polski 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV PT = português 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV RO = română 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV SK = slovenčina 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV SL = slovenščina 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV FI = suomi 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV SV = svenska 2014-09-02  
Dexamed and associated names Article-29(4) referral - Annex IV HR = Hrvatski 2014-09-02  

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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision