Diotop capsules - referral

Current status

European Commission final decision

Overview

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.

What is Diotop?

Diotop is a medicine used to relieve symptoms such as swelling and pain caused by the joint disorders rheumatoid arthritis, osteoarthritis or ankylosing spondylitis. Diotop is used in adult patients who are at risk of developing stomach ulcers and whose disease is already controlled by diclofenac and omeprazole, the two active substances in Diotop, taken separately.

The two active substances in Diotop have different effects. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used for the relief of pain and inflammation in a wide range of conditions. Omeprazole is a widely-used treatment for indigestion and acid reflux that acts by reducing the amount of acid the stomach makes. Both diclofenac and omeprazole have been authorised in the EU for many years.

Why was Diotop reviewed?

Temmler Pharma GmbH requested that the marketing authorisation for Diotop granted by the UK and Austria in 2016 be recognised in Germany (the ‘concerned Member State’).

However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 28 September 2018.

The grounds for the referral were concerns raised by Germany that the data provided by the company were not enough to demonstrate the safety and effectiveness of Diotop.

What is the outcome of the review?

The company submitted data from the published literature on the use of several NSAIDs (including diclofenac at the dose of 50 to 150 mg a day) and omeprazole in combination. The Agency considered that, although the particular combination in Diotop (diclofenac 75 mg / omeprazole 20 mg) has never been tested in any published study, the data from studies of higher doses of diclofenac or other NSAIDs taken with omeprazole are enough to support the use of the specific combination in Diotop.

The Agency therefore concluded that the benefits of Diotop outweigh its risks, and therefore the marketing authorisation for Diotop should be granted in Germany.

More about the procedure

The review of Diotop was initiated at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC.

The review was carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.

A European Commission decision valid throughout the EU will be issued in due course.

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

Reference Number: EMA/790726/2018

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:
  EMEA/H/A-29(4)/1474
• 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.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• CHMP opinion date:
  15/11/2018
• EC decision date:
  31/01/2019

All documents

Opinion provided by Committee for Medicinal Products for human Use

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

Reference Number: EMA/790726/2018

European Commission final decision

Diotop Article 29(4) referral - Assessment report

Reference Number: EMA/813519/2018

Diotop Article 29(4) referral - Annex III

Diotop Article 29(4) referral - Annex II

Diotop Article 29(4) referral - Annex I

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.