Simvastatin Vale

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision

Overview

On 25 March 2013, 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 Simvastatin Vale. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Simvastatin Vale outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway.

Key facts

About this medicine
Approved name
Simvastatin Vale
International non-proprietary name (INN) or common name
simvastatin
Associated names
Simvastatin Vale pharmaceuticals
Class
Statin
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-29/1358
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
25/03/2013
EC decision date
27/05/2013

All documents

European Commission final decision

  • List item

    Questions and answers on Simvastatin Vale and associated names (simvastatin, oral suspension, 20 mg / 5 ml and 40 mg / 5 ml) (PDF/66.15 KB)


    First published: 03/04/2013
    Last updated: 22/07/2013
    EMA/169486/2013 Rev. 1

  • List item

    Simvastatin Vale Article-29(4) referral - Annex I (PDF/71.8 KB)


    First published: 22/07/2013
    Last updated: 22/07/2013

  • List item

    Simvastatin Vale Article-29(4) referral - Annex II (PDF/28.38 KB)


    First published: 22/07/2013
    Last updated: 22/07/2013

  • List item

    Simvastatin Vale Article-29(4) referral - Annex III (PDF/14.27 KB)


    First published: 22/07/2013
    Last updated: 22/07/2013

  • List item

    Assessment report for Simvastatin Vale and associated names (PDF/116.96 KB)


    First published: 22/07/2013
    Last updated: 22/07/2013
    EMA/264659/2013

  • 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.

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