Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

A Segec; B Keller-Stanislawski; N S Vermeer; C Macchiarulo; S M Straus; A Hidalgo-Simon; M L De Bruin

doi:10.1002/cpt.199

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

A Segec, B Keller-Stanislawski, N S Vermeer, C Macchiarulo, S M Straus, A Hidalgo-Simon, M L De Bruin

Pharmacoepidemiology and Clinical Pharmacology

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.

Original language	English
Pages (from-to)	502-505
Number of pages	4
Journal	Clinical Pharmacology and Therapeutics
Volume	98
Issue number	5
DOIs	https://doi.org/10.1002/cpt.199
Publication status	Published - Nov 2015

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Segec_et_al-2015-Clinical_Pharmacology_&_TherapeuticsFinal published version, 694 KBLicence: Taverne

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abstract = "Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.",

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AU - Straus, S M

AU - Hidalgo-Simon, A

AU - De Bruin, M L

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Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

Abstract

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