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

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Segec_et_al_2015_Clinical_Pharmacology_Therapeutics.pdf (693.76 KB)

Publication date

2015-11

Authors

Segec, A
Keller-Stanislawski, B
Vermeer, N SISNI 0000000507779771
Macchiarulo, C
Straus, S M
Hidalgo-Simon, A
De Bruin, M.L.ORCID 0000-0001-9197-7068ISNI 0000000397182332

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DOI

https://doi.org/10.1002/cpt.199

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Article

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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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Citation

Segec, A, Keller-Stanislawski, B, Vermeer, N S, Macchiarulo, C, Straus, S M, Hidalgo-Simon, A & De Bruin, M L 2015, 'Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy', Clinical Pharmacology and Therapeutics, vol. 98, no. 5, pp. 502-505. https://doi.org/10.1002/cpt.199

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http://hdl.handle.net/1874/330056