Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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.
Key facts
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About this medicine
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|---|---|
| Approved name |
Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
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| International non-proprietary name (INN) or common name |
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| Associated names |
Paracomb
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About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-29(4)/1447
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| 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. |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
18/05/2017
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| EC decision date |
07/08/2017
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All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - CHMP assessment report (PDF/616.86 KB)
First published: 18/08/2017
Last updated: 18/08/2017
EMA/517503/2017
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex I (PDF/33.2 KB)
First published: 18/08/2017
Last updated: 18/08/2017
Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II (PDF/56.81 KB)
First published: 18/08/2017
Last updated: 18/08/2017
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.