Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets - referral

Current status

European Commission final decision

Overview

On 18 May 2017, 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 Paracetamol/ibuprofen 500mg/150mg film-coated tablets. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Paracetamol/ibuprofen 500mg/150mg film-coated tablets outweigh its risks, and the marketing authorisation can be granted
in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Croatia, France, Germany, Ireland, Luxembourg, the Netherlands, Portugal and Spain.

What is Paracetamol/ibuprofen 500mg/150mg film-coated tablets?

Paracetamol/ibuprofen 500mg/150mg film-coated tablets is a medicine for use in adults for the shortterm treatment of mild to moderate pain.

Paracetamol/ibuprofen 500mg/150mg contains the active substances paracetamol and ibuprofen. Both are well known medicines that work in different ways to relieve pain. Combinations of paracetamol and ibuprofen containing 500 mg paracetamol and 150 mg ibuprofen or similar doses are already available in many EU countries.

Why was Paracetamol/ibuprofen 500mg/150mg film-coated tablets reviewed?

Vale Pharmaceuticals Limited submitted Paracetamol/ibuprofen 500mg/150mg film-coated tablets to the United Kingdom for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance the United Kingdom) 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, Croatia, France, Germany, Ireland, Luxembourg, the Netherlands, Portugal and Spain).

However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 21 October 2016.

The grounds for the referral were that the rationale for use of this medicine for the short-term treatment of mild to moderate pain without medical supervision was not sufficiently justified. There were concerns about potential long-term use which is not authorised and whether the dose used was the best one to choose. In addition, concerned Member States felt that benefits for this fixed-dose combination over the individual components had not been consistently shown across studies and that safety in the intended population, including elderly patients, had not been sufficiently proven.

What are the conclusions of the CHMP?

The CHMP assessed the available data from studies and from the scientific literature provided by the company to support the use of this combination in the short-term treatment of pain. The data showed that the use of the fixed-dose combination of 500 mg paracetamol and 150 mg ibuprofen is safe and effective in adults, including the elderly. The CHMP concluded that this combination was more effective than the individual components, while its safety profile was similar. Using the combination may avoid having to use stronger painkillers such as opioids which have risks of abuse and misuse. To address the risk of potential long-term use the applicant provided data obtained after marketing to show that similar combinations have not led to significant long-term use or increased safety concerns.

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Paracetamol/ibuprofen 500mg/150mg film-coated tablets outweigh its risks, and therefore the marketing authorisation for Paracetamol/ibuprofen 500mg/150mg film-coated tablets should be granted in all concerned Member States.

The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Paracetamol/ibuprofen 500mg/150mg film-coated tablets on 07/08/2017.

Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Questions and answers on Paracetamol/ibuprofen 500mg/150mg film-coated tablets and associated names (tablets containing 500 mg paracetamol and 150 mg ibuprofen)

Reference Number: EMA/304852/2017

Key facts

About this medicine

• Approved name:
  Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
• International non-proprietary name (INN) or common name:
  • paracetamol
  • ibuprofen
• Associated names:
  Paracomb

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29(4)/1447
• 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:
  18/05/2017
• EC decision date:
  07/08/2017

All documents

Opinion provided by Committee for Medicinal Products for human Use

Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III

Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Questions and answers on Paracetamol/ibuprofen 500mg/150mg film-coated tablets and associated names (tablets containing 500 mg paracetamol and 150 mg ibuprofen)

Reference Number: EMA/304852/2017

European Commission final decision

Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - CHMP assessment report

Reference Number: EMA/517503/2017

Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I

Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II

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.