Loraxin - referral

Current status

European Commission final decision

Overview

On 21 June 2012, 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 Loraxin. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that it was not possible to show that the benefits of Loraxin outweigh its risks based on the data submitted by the company. The Committee therefore recommended that the marketing authorisation granted in Finland should not be recognised in other Member States of the EU. The marketing authorisation in Finland should also be suspended.

What is Loraxin?

Loraxin is a medicine used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever or allergy to dust mites) and long-term idiopathic urticaria (itchy rash). 'Idiopathic' means that the cause of the urticaria is not known.

The active substance in Loraxin, loratadine, is an antihistamine. It works by blocking receptors for histamine, a substance in the body that causes allergic symptoms.

Why was Loraxin reviewed?

Vitabalans Oy submitted an application for Loraxin for mutual recognition, on the basis of an initial authorisation granted by Finland on 31 August 2010. The initial authorisation was based on a well-established-use application. This means that the use of the active substance has been well established in the EU for over ten years. The company wanted the authorisation to be recognised in the Czech Republic, Denmark, Estonia, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia and Slovakia (the 'concerned Member States').

However, the Member States were not able to reach an agreement and the Finnish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 December 2011.

The grounds for the referral were the concerns of the Swedish and Polish medicines agencies that its safety and benefits could not be ascertained on the basis of the data that were submitted.

What are the conclusions of the CHMP?

For well-established use applications, data from the published literature on medicines with the same active substance are used to show the benefits and safety of a medicine. The CHMP noted that the published data that was submitted with this application were limited, and not sufficient to support this well-established use application for Loraxin. Therefore, the Committee concluded that the benefits of the medicine could not be shown to outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States. In addition, the Committee recommended that the marketing authorisation for Loraxin in Finland should be suspended.

The European Commission issued a decision on 20 December 2012.

Questions and answers on Loraxin and associated names (loratadine, 10 mg tablets)

Reference Number: EMA/417631/2012 Rev1

Key facts

About this medicine

• Approved name:
  Loraxin
• International non-proprietary name (INN) or common name:
  loratadine
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1325
• 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:
  18/10/2012
• EC decision date:
  20/12/2012

All documents

Opinion provided by Committee for Medicinal Products for human Use

Questions and answers on Loraxin and associated names (loratadine, 10 mg tablets)

Reference Number: EMA/417631/2012 Rev1

European Commission final decision

Loraxin - Article-29(4) referral - Annex I, II, III

Loraxin - Article-29(4) referral - Assessment report

Reference Number: EMA/29457/2013

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.