Escitalopram - referral

Current status

CHMP opinion

Overview

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

The European Medicines Agency has completed a review of a group of generic escitalopram-containing medicines that were authorised via a decentralised procedure. The Agency's Committee for Medicinal Products for Human Use (CHMP) has noted that there is a need to harmonise the decisions taken in European Union (EU) Member States involved in this decentralised procedure on whether to maintain or suspend the marketing authorisations of these medicines. The CHMP concluded that marketing authorisations for the medicines should be suspended.

A European Commission decision on this opinion will be issued in due course.

What is escitalopram?

Escitalopram is an antidepressant used to treat major depressive episodes. These are periods of depressed mood. Escitalopram is a 'selective serotonin reuptake inhibitor' (SSRI). It works by preventing the neurotransmitter serotonin from being taken back up into nerve cells in the brain and spinal cord. Neurotransmitters are chemicals that transfer chemical signals from one nerve cell to another. Low levels of serotonin in the central nervous system are thought to be associated with depression or anxiety.

Some generic medicines containing escitalopram have been authorised based on their similarity to the reference medicine Cipramil, which contains a mixture of escitalopram and its 'enantiomer' (a molecule with the same atoms arranged in a slightly different way so that it is a mirror image of escitalopram). The authorisations were granted as part of a 'decentralised procedure': one Member State (the 'reference Member State', in this instance the Netherlands) granted an authorisation that was valid in this country as well as in other Member States (the 'concerned Member States', in this instance Austria, Belgium, Germany, Hungary, Lithuania, Luxembourg, the Netherlands, Portugal, Slovenia and the United Kingdom).

These medicines are available under the following trade names: Escitaburg, Escitafloc, Escitaham, Escitalobene, Escitalis, Escitalodeon, Escitalofi, Escitalopram, Escitalopram-1A, Escitalopram AbZ, Escitalopram Beta, Escitalopram CF, Escitalopram-CT, Escitalopram Ecitrix, Escitalopram Hexal Escitalopram Ratiopharm, Escitalopram Sandoz, Escitalopram Stada, Escitalopram Tiefenbacher, Escitalopram Winthrop, Escitatifi and Kapistrol.

Why were these escitalopram-containing medicines reviewed?

In April 2009, the Dutch medicines regulatory agency suspended the marketing authorisation of these medicines in the Netherlands as some of the data that were used to support their applications was considered to still be protected 'under data exclusivity'. As the medicines were still authorised in the other Member States, the United Kingdom medicines regulatory agency referred the matter to the CHMP for an opinion on whether the authorisations should be maintained or suspended in all the Member States involved in the decentralised procedure.

What are the conclusions of the CHMP?

The CHMP evaluated the data that was not considered to be protected under the data exclusivity rules, and concluded that there was insufficient evidence to show that the generic medicines had comparable effectiveness and safety as the reference medicine. Based on this, the Committee recommended that marketing authorisations for these medicines should be suspended.

Questions and answers on generic escitalopram-containing medicines (tablets containing escitalopram oxalate, 5, 10, 15 and 20 mg)

AdoptedReference Number: EMA/89593/2010Summary:

The European Medicines Agency has completed a review of a group of generic escitalopram-containing medicines that were authorised via a decentralised procedure.

Key facts

About this medicine

• Approved name:
  Escitalopram
• International non-proprietary name (INN) or common name:
  escitalopram

About this procedure

• Current status:
  CHMP opinion
• Reference number:
  EMEA/H/A-30/1231
• 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:
  18/02/2010

All documents

Questions and answers on generic escitalopram-containing medicines (tablets containing escitalopram oxalate, 5, 10, 15 and 20 mg)

AdoptedReference Number: EMA/89593/2010Summary:

The European Medicines Agency has completed a review of a group of generic escitalopram-containing medicines that were authorised via a decentralised procedure.

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.