New safety signals assessed by the Pharmacovigilance Risk Assessment Committee at EU level in 2014

New safety signals assessed by the Pharmacovigilance Risk Assessment Committee at EU level in 2014–2017

Published:2018-10-01 Issue:10 Volume:11 Page:1045-1051
ISSN:1751-2433
Container-title:Expert Review of Clinical Pharmacology
language:en
Short-container-title:Expert Review of Clinical Pharmacology

Author:

Farcaş Andrea¹,Măhălean Andreea¹,Bulik Noémi Beátrix¹,Leucuta Daniel²^ORCID,Mogoșan Cristina¹

Affiliation:

1. Drug Information Research Center, “Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania

2. Medical Informatics and Biostatistics Department, “Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Pharmacology, Toxicology and Pharmaceutics,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/17512433.2018.1526676

Reference29 articles.

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3. Commission of the European Communities. Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use. COM(2008) 665 final [online] [cited 2018 Feb 23]. Available from: http://eur-lex.europa.eu/LexUriServ/%20LexUriServ.do?uri=COM:2008:0665:FIN:en:PDF

4. Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works

5. The European Parliament and the Council of the European Union. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products [online] [cited 2018 Jan 24]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF

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