A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006-2015

Rubino Annalisa; Artime Esther

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A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006-2015

机译：2006 - 2015年欧盟集中授权药物额外风险最小化措施的描述性综述

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Background: Guidance on therapeutic risk management, first released in EU in 2005, was updated in 2012-2013 with increased requirements on additional risk minimisation measures (aRMM). This study describes aRMM imposed at initial EU central marketing authorisation of medicines in 2006-2015.

机译：背景：2005年欧盟首次发布的治疗风险管理指南，于2012 - 2013年更新，提高了对额外风险最小化措施（ARMM）的要求。本研究描述了2006 - 2015年药物初始欧盟中央营销授权的ARMM。

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来源
《Expert opinion on drug safety》 |2017年第12期|共8页
作者
Rubino Annalisa; Artime Esther;
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作者单位

OXON Epidemiol Risk Management Epidemiol London England;

OXON Epidemiol Risk Management Epidemiol Madrid Spain;

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原文格式 PDF
正文语种 eng
中图分类药品;
关键词
Risk minimisation measures; risk management; effectiveness evaluation; pharmacovigilance; educational interventions;

机译：风险最小化措施;风险管理;有效性评估;药物理论;教育干预措施;

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1. A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006-2015 [J] . Rubino Annalisa, Artime Esther Expert opinion on drug safety . 2017,第7a12期

机译：2006 - 2015年欧盟集中授权药物额外风险最小化措施的描述性综述
2. A Qualitative and Quantitative Review of Additional Risk Minimisation Measures for EU Centrally Authorised Products, 2006-2014 [J] . Artime E., Rubino A., Qizilbash N. Drug safety: An international journal of medical toxicology and drug experience . 2015,第10期

机译：2006-2014年欧盟中央授权产品附加风险最小化措施的定性和定量审查
3. Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder [J] . Elaine Agyemang, Lorna Bailey, John Talbot Pharmaceutical medicine . 2017,第2期

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A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006-2015

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