Ibuprofen Kabi 400 mg Infusionslösung and associated names - referral

Current status

European Commission final decision

Overview

EMA recommends authorisation of Ibuprofen Kabi (ibuprofen, 400 mg solution for infusion) in the EU

On 23 July 2020, the European Medicines Agency completed a review of Ibuprofen Kabi following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Ibuprofen Kabi outweigh its risks, and the marketing authorisation can be granted in Germany and in other Member States of the EU where the company has applied for a marketing authorisation (Austria, Belgium, Czechia, Hungary, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia, Spain) as well as the United Kingdom.

What is Ibuprofen Kabi?

The active substance in Ibuprofen Kabi, ibuprofen, is a non-steroidal anti-inflammatory drug (NSAID) and has been used since the 1960s as a painkiller and anti-inflammatory medicine. It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins, Ibuprofen Kabi is expected to reduce fever and pain linked to inflammation.

Ibuprofen Kabi was developed as a hybrid medicine. This means that it was developed to be similar to a ‘reference medicine’ containing the same active substance but is given in a different way. While the reference medicine Espidifen 400 mg is available as granules for oral solution, Ibuprofen Kabi is to be given as an intravenous injection (into a vein).

Why was Ibuprofen Kabi reviewed?

Fresenius Kabi Deutschland GmbH submitted Ibuprofen Kabi to the German medicines agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance Austria, Belgium, Czechia, Hungary, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia, Spain) as well as the United Kingdom where the company has applied for a marketing authorisation.

However, the Member States were not able to reach an agreement and the Netherlands referred the matter to EMA for arbitration on 16 March 2020.

The applicant presented results from a comparison of quality aspects of other authorised intravenous ibuprofen solutions, and data from the literature on the pharmacokinetics (how a medicine is absorbed, modified and removed from the body) as well effectiveness and safety of intravenous ibuprofen.

The grounds for the referral were that the company had not provided the required data comparing Ibuprofen Kabi with Espidifen.

What is the outcome of the review?

Based on the evaluation of the available data, the Agency concluded that the data provided are sufficient to support the safety and effectiveness of Ibuprofen Kabi. The Agency therefore concluded that the benefits of Ibuprofen Kabi outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.

More about the procedure

The review of Ibuprofen Kabi was initiated on 16 March 2020 at the request of the Netherlands 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 was issued on 15 October 2020.

Ibuprofen Kabi 400 mg Article 29(4) referral - EMA recommends authorisation of Ibuprofen Kabi (ibuprofen, 400 mg solution for infusion) in the EU

Reference Number: EMA/564161/2020

Key facts

About this medicine

• Approved name:
  Ibuprofen Kabi 400 mg Infusionslösung and associated names
• International non-proprietary name (INN) or common name:
  ibuprofen
• Associated names:
  • Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie
  • Ibuprofen Fresenius Kabi 400 mg solution pour perfusion
  • Ibuprofen Kabi
  • Ibuprofen Kabi 400 mg oldatos infúzió
  • Ibuprofen Kabi 400 mg soluţie perfuzabilă
  • Ibuprofen Kabi 400 mg
  • Ibuprofen Kabi 400 mg raztopina za infundiranje
  • Ibuprofeno Kabi 400 mg solución para perfusion
  • Ibuprofen Kabi 400 mg Solution for Infusion

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29(4)/1498
• 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:
  23/07/2020
• EC decision date:
  15/10/2020

All documents

Opinion provided by Committee for Medicinal Products for human Use

Ibuprofen Kabi 400 mg Article 29(4) referral - Assessment report

Adopted Reference Number: EMA/516696/2020

Ibuprofen Kabi 400 mg Article 29(4) referral - Annex II

Ibuprofen Kabi 400 mg Article 29(4) referral - Annex I

Ibuprofen Kabi 400 mg Article 29(4) referral - Annex III

Ibuprofen Kabi 400 mg Article 29(4) referral - EMA recommends authorisation of Ibuprofen Kabi (ibuprofen, 400 mg solution for infusion) in the EU

Reference Number: EMA/564161/2020

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.