Dexamethasone Alapis

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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 Dexamethasone Alapis. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Dexamethasone Alapis outweigh its risks, and the marketing authorisation can be granted in Malta and in the following Member States of the EU: Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom.

What is Dexamethasone Alapis?

Dexamethasone Alapis is a medicine that contains the active substance dexamethasone. It is available as an oral solution (0.4 mg/ml). The active substance in Dexamethasone Alapis, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids. It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation and swelling.

Dexamethasone Alapis is intended for use principally as an anti-inflammatory or immunosuppressant (a medicine that reduces the activity of the immune system) in a range of specific disorders affecting different parts of the body, including the blood, liver, kidney, stomach and gut, muscles, eye, lungs and skin, as well as in certain cancers and in the management of anaphylaxis (severe allergic reaction).

Why was Dexamethasone Alapis reviewed?

Alapis S.A. submitted Dexamethasone Alapis to Malta for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Malta) assesses a medicine with a view to 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 Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom).

However, the Member States were not able to reach an agreement and the Maltese medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011.

The German medicines regulatory authority was of the opinion that the data submitted to support the application did not provide sufficient evidence to demonstrate the safety and effectiveness of Dexamethasone Alapis. The grounds for the referral were that the application, which was supported by published literature rather than studies carried out with Dexamethasone Alapis, because dexamethasone has a history of well-established use in the EU for at least 10 years, was mainly supported by literature demonstrating the safety and efficacy of dexamethasone in tablet form rather than oral solution form and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of the oral solution form.

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 data submitted was sufficient to show that Dexamethasone Alapis could be used safely and effectively based on the well established use of dexamethasone. The CHMP concluded that the benefits of Dexamethasone Alapis outweigh its risks, and therefore the marketing authorisation for Dexamethasone Alapis should be granted in all concerned Member States.

The European Commission issued a decision on 24 October 2011.

Name Language First published Last updated
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) BG = bălgarski 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) ES = español 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) CS = čeština 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) DA = dansk 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) DE = Deutsch 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) ET = eesti keel 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) EL = elliniká 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) EN = English 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) FR = français 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) IT = italiano 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) LV = latviešu valoda 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) LT = lietuvių kalba 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) HU = magyar 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) MT = Malti 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) NL = Nederlands 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) PL = polski 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) PT = português 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) RO = română 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) SK = slovenčina 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) SL = slovenščina 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) FI = suomi 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) SV = svenska 22/07/2011 02/02/2012

Key facts

Approved nameDexamethasone Alapis
International non-proprietary name (INN) or common name

Dexamethasone

Associated names
Class
Reference numberEMEA/H/A-29/1308
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 date21/07/2011

All documents

Name Language First published Last updated
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) BG = bălgarski 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) ES = español 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) CS = čeština 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) DA = dansk 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) DE = Deutsch 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) ET = eesti keel 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) EL = elliniká 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) EN = English 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) FR = français 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) IT = italiano 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) LV = latviešu valoda 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) LT = lietuvių kalba 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) HU = magyar 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) MT = Malti 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) NL = Nederlands 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) PL = polski 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) PT = português 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) RO = română 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) SK = slovenčina 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) SL = slovenščina 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) FI = suomi 22/07/2011 02/02/2012
Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml) SV = svenska 22/07/2011 02/02/2012
Dexamethasone Alapis - Article 29 referral - Assessment Report (English only) 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I BG = bălgarski 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I ES = español 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I CS = čeština 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I DA = dansk 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I DE = Deutsch 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I ET = eesti keel 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I EL = elliniká 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I EN = English 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I FR = français 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I IT = italiano 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I LV = latviešu valoda 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I LT = lietuvių kalba 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I HU = magyar 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I MT = Malti 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I NL = Nederlands 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I PL = polski 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I PT = português 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I RO = română 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I SK = slovenčina 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I SL = slovenščina 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I FI = suomi 02/02/2012  
Dexamethasone Alapis - Article 29 referral - Annex I SV = svenska 02/02/2012  
Dexamethasone - Article 29 referral - Annex II BG = bălgarski 02/02/2012  
Dexamethasone - Article 29 referral - Annex II ES = español 02/02/2012  
Dexamethasone - Article 29 referral - Annex II CS = čeština 02/02/2012  
Dexamethasone - Article 29 referral - Annex II DA = dansk 02/02/2012  
Dexamethasone - Article 29 referral - Annex II DE = Deutsch 02/02/2012  
Dexamethasone - Article 29 referral - Annex II ET = eesti keel 02/02/2012  
Dexamethasone - Article 29 referral - Annex II EL = elliniká 02/02/2012  
Dexamethasone - Article 29 referral - Annex II EN = English 02/02/2012  
Dexamethasone - Article 29 referral - Annex II FR = français 02/02/2012  
Dexamethasone - Article 29 referral - Annex II IT = italiano 02/02/2012  
Dexamethasone - Article 29 referral - Annex II LV = latviešu valoda 02/02/2012  
Dexamethasone - Article 29 referral - Annex II LT = lietuvių kalba 02/02/2012  
Dexamethasone - Article 29 referral - Annex II HU = magyar 02/02/2012  
Dexamethasone - Article 29 referral - Annex II MT = Malti 02/02/2012  
Dexamethasone - Article 29 referral - Annex II NL = Nederlands 02/02/2012  
Dexamethasone - Article 29 referral - Annex II PL = polski 02/02/2012  
Dexamethasone - Article 29 referral - Annex II PT = português 02/02/2012  
Dexamethasone - Article 29 referral - Annex II RO = română 02/02/2012  
Dexamethasone - Article 29 referral - Annex II SK = slovenčina 02/02/2012  
Dexamethasone - Article 29 referral - Annex II SL = slovenščina 02/02/2012  
Dexamethasone - Article 29 referral - Annex II FI = suomi 02/02/2012  
Dexamethasone - Article 29 referral - Annex II SV = svenska 02/02/2012  
Dexamethasone - Article 29 referral - Annex III BG = bălgarski 02/02/2012  
Dexamethasone - Article 29 referral - Annex III ES = español 02/02/2012  
Dexamethasone - Article 29 referral - Annex III CS = čeština 02/02/2012  
Dexamethasone - Article 29 referral - Annex III DA = dansk 02/02/2012  
Dexamethasone - Article 29 referral - Annex III DE = Deutsch 02/02/2012  
Dexamethasone - Article 29 referral - Annex III ET = eesti keel 02/02/2012  
Dexamethasone - Article 29 referral - Annex III EL = elliniká 02/02/2012  
Dexamethasone - Article 29 referral - Annex III EN = English 02/02/2012  
Dexamethasone - Article 29 referral - Annex III FR = français 02/02/2012  
Dexamethasone - Article 29 referral - Annex III IT = italiano 02/02/2012  
Dexamethasone - Article 29 referral - Annex III LV = latviešu valoda 02/02/2012  
Dexamethasone - Article 29 referral - Annex III LT = lietuvių kalba 02/02/2012  
Dexamethasone - Article 29 referral - Annex III HU = magyar 02/02/2012  
Dexamethasone - Article 29 referral - Annex III MT = Malti 02/02/2012  
Dexamethasone - Article 29 referral - Annex III NL = Nederlands 02/02/2012  
Dexamethasone - Article 29 referral - Annex III PL = polski 02/02/2012  
Dexamethasone - Article 29 referral - Annex III PT = português 02/02/2012  
Dexamethasone - Article 29 referral - Annex III RO = română 02/02/2012  
Dexamethasone - Article 29 referral - Annex III SK = slovenčina 02/02/2012  
Dexamethasone - Article 29 referral - Annex III SL = slovenščina 02/02/2012  
Dexamethasone - Article 29 referral - Annex III FI = suomi 02/02/2012  
Dexamethasone - Article 29 referral - Annex III SV = svenska 02/02/2012  

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