Dexamethasone Alapis - 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 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.

Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml)

AdoptedReference Number: EMA/CHMP/582483/2011

Key facts

About this medicine

• Approved name:
  Dexamethasone Alapis
• International non-proprietary name (INN) or common name:
  dexamethasone

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1308
• 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:
  21/07/2011
• EC decision date:
  24/10/2011

All documents

Dexamethasone Alapis - Article 29 referral - Assessment Report

AdoptedReference Number: EMEA/H/A-29/1308

Dexamethasone Alapis - Article 29 referral - Annex I

Dexamethasone - Article 29 referral - Annex II

Dexamethasone - Article 29 referral - Annex III

Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml)

AdoptedReference Number: EMA/CHMP/582483/2011

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.