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

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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.

Key facts

Approved nameParacetamol/Ibuprofen 500 mg/150 mg film-coated tablets
International non-proprietary name (INN) or common name

paracetamol-ibuprofen

Associated namesParacomb
Class
Reference numberEMEA/H/A-29(4)/1447
TypeArticle 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

StatusEuropean Commission final decision
Opinion date18/05/2017

All documents

Name Language First published Last updated
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) (English only) 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - CHMP assessment report (English only) 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I BG = bălgarski 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I ES = español 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I CS = čeština 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I DA = dansk 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I DE = Deutsch 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I ET = eesti keel 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I EL = elliniká 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I EN = English 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I FR = français 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I IT = italiano 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I LV = latviešu valoda 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I LT = lietuvių kalba 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I HU = magyar 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I MT = Malti 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I NL = Nederlands 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I PL = polski 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I PT = português 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I RO = română 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I SK = slovenčina 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I SL = slovenščina 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I FI = suomi 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I SV = svenska 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I HR = Hrvatski 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II BG = bălgarski 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II ES = español 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II CS = čeština 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II DA = dansk 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II DE = Deutsch 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II ET = eesti keel 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II EL = elliniká 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II EN = English 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II FR = français 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II IT = italiano 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II LV = latviešu valoda 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II LT = lietuvių kalba 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II HU = magyar 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II MT = Malti 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II NL = Nederlands 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II PL = polski 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II PT = português 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II RO = română 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II SK = slovenčina 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II SL = slovenščina 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II FI = suomi 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II SV = svenska 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II HR = Hrvatski 2017-08-18  
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III BG = bălgarski 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III ES = español 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III CS = čeština 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III DA = dansk 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III DE = Deutsch 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III ET = eesti keel 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III EL = elliniká 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III EN = English 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III FR = français 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III IT = italiano 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III LV = latviešu valoda 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III LT = lietuvių kalba 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III HU = magyar 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III MT = Malti 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III NL = Nederlands 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III PL = polski 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III PT = português 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III RO = română 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III SK = slovenčina 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III SL = slovenščina 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III FI = suomi 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III SV = svenska 2017-05-19 2017-08-18
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex III HR = Hrvatski 2017-05-19 2017-08-18

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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