Diotop capsules

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


On 15 November 2018, the European Medicines Agency completed a review of Diotop following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Diotop outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.

Key facts

About this medicine
Approved name
Diotop capsules
International non-proprietary name (INN) or common name
  • diclofenac
  • omeprazole
About this procedure
Current status
European Commission final decision
Reference number
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.

Authorisation model
Nationally authorised product(s)
Key dates and outcomes
CHMP opinion date
EC decision date

All documents

  • List item

    Diotop Article 29(4) referral - EMA recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU (PDF/75.98 KB)

    First published: 16/11/2018
    Last updated: 15/02/2019

  • European Commission final decision

  • List item

    Diotop Article 29(4) referral - Assessment report (PDF/162.17 KB)

    First published: 15/02/2019

  • List item

    Diotop Article 29(4) referral - Annex III (PDF/8.17 KB)

    First published: 15/02/2019

  • List item

    Diotop Article 29(4) referral - Annex II (PDF/23.61 KB)

    First published: 15/02/2019

  • List item

    Diotop Article 29(4) referral - Annex I (PDF/11.84 KB)

    First published: 15/02/2019

  • 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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