Risk Minimization Activities of Centrally Authorized Products in the EU: A Descriptive Study
Risk Minimization Activities of Centrally Authorized Products in the EU: A Descriptive Study
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Cham: Springer International Publishing
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Language
English
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Cham: Springer International Publishing
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Background:
Since the new legislation on risk management, which came into force in November 2005, an EU Risk Management Plan (EU-RMP) is a required part of the authorization dossier of innovative drugs licensed in the EU. The EU-RMP can include additional risk minimization activities (RMAs) to strengthen the benefit-risk balance of a drug. This...
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Risk Minimization Activities of Centrally Authorized Products in the EU: A Descriptive Study
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TN_cdi_crossref_primary_10_2165_11594560_000000000_00000
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https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_crossref_primary_10_2165_11594560_000000000_00000
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ISSN
0114-5916
E-ISSN
1179-1942
DOI
10.2165/11594560-000000000-00000
