Article-5(3) opinions

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This page lists the opinions drawn up by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) under Article 5(3) of the Regulation establishing the EMA, concerning any scientific matter related to the evaluation of medicines for use in humans.

The Committee must draw up such an opinion at the request of the Executive Director of the EMA or of the European Commission. It may also draw up an opinion following a request from a Member State.

Where the scientific issue concerns both human and veterinary medicines, the Committee may adopt a common opinion with the Committee for Medicinal Products for Veterinary Use (CVMP).

Requests for this type of scientific opinion fall under Article 5(3) of Regulation (EC) No 726/2004.

Table of contents


Review of polymyxin-based products

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Polymyxin-based products (English only) adopted 2015-05-26    

Review of medical products under development for treatment of Ebola

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Medicinal products under development for treatment of Ebola (English only) adopted 2016-03-14    
Interim assessment report for Article-5(3) procedure: Medicinal products under development for treatment of Ebola (English only) adopted 2014-12-16 2015-02-02  

Review of propylene glycol in medicinal products for children

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Propylene glycol in medicinal products for children (English only) adopted 2014-03-27    

Review of GLP-1-based therapies

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: GLP-1-based therapies (English only) adopted 2013-08-01    

Review of Octagam

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Octagam and associated names (English only) adopted 2013-05-28    

Review of teicoplanin-containing medicinal products

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Teicoplanin-containing medicinal products (English only) adopted 2013-04-22    

Supply chain for protamine-containing medicinal products

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Protamine-containing medicinal products (English only) adopted 2012-12-06    

Hypothesis on Pandemrix and development of narcolepsy

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Immunological differences of pandemic vaccines (review of hypothesis on Pandemrix and development of narcolepsy) (English only)   2012-11-12    

Non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk

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Anti-tuberculosis medicines used in children: review of dosing recommendations from the World Health Organization (WHO)

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Angiotensin-II-receptor antagonists and the risk of cancer

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Angiotensin II (type-1) receptor antagonists and risk of cancer (English only) adopted 2012-02-09    
Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (English only)   2011-10-20    

Particles on silicone tubing of diphtheria and tetanus toxoid (DT) and diphtheria/tetanus toxoid/pertussis (DTwP) antigen bulk containers

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Potential off-label use of celecoxib in patients with familial adenomatous polyposis

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Presence of endotoxins in Baxter peritoneal dialysis solutions

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Document(s) Language Status First published Last updated Effective Date
Assessment report for Article-5(3) procedure: Presence of endotoxins in Baxter peritoneal dialysis solutions (English only)   2010-12-20    
Questions and answers on the presence of endotoxins in Baxter peritoneal dialysis solutions (English only)   2010-12-17    

Detection of unexpected viral DNA in live attenuated vaccines

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Bisphosphonates and osteonecrosis of the jaw

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Novel influenza (H1N1) outbreak: Tamiflu (oseltamivir) and Relenza (zanamivir)

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Conventional antipsychotics

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Antidepressants

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Document(s) Language Status First published Last updated Effective Date
Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on antidepressants (English only)   2008-07-04    
Letter on efficacy of antidepressants (English only)   2008-03-18    
CHMP assessment report on antidepressants under Article 5(3) of Regulation (EC) No 726/2004 (English only)   2008-05-30    

Medicinal products containing or derived from heparin

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Document(s) Language Status First published Last updated Effective Date
Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on heparins (English only)   2008-06-06    
CHMP assessment report for medicinal products containing or derived from heparin under Article 5(3) of Regulation (EC) No 726/2004 (English only)   2008-05-30    
Questions and answers on heparins (English only)   2008-06-05    

Potential risk of carcinogens, mutagens and substances toxic to reproduction when these substances are used as excipients of medicinal products for human use

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Adequacy of guidance on the elderly regarding medicinal products for human use

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Document(s) Language Status First published Last updated Effective Date
Adequacy of guidance on the elderly regarding medicinal products for human use (English only)   2006-12-13    

Non-selective non-steroidal anti-inflammatory drugs (NSAIDs)

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