Evaluation of the effectiveness of additional risk minimisation measures (aRMMs) that aim to reduce the risks of phototoxicity, squamous cell carcinoma (SCC) of the skin and hepatic toxicity in patients receiving voriconazole in the European Union (EU)

First published 29/07/2015

Last updated 22/02/2024

EU PAS number:

EUPAS10428

Study

Finalised

Documents

Study protocol

Initial protocol

A1501102_VFEND aRMM evalution survey PROTOCOL_FINAL REDACTED_7_28_2015_B

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Updated protocol

A1501102_PROTOCOL AND APPROVAL_NIS_08JULY2015_FINAL_part1

First published: 22/02/2024

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Study results

a1501102-report-body_1

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Study report

a1501102-abstract

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Other information

Study, other information

A1501102_PROTOCOL AND APPROVAL_NIS_08JULY2015_FINAL_part2

English (1.68 MB - PDF)View document

A1501102_PROTOCOL AND APPROVAL_NIS_08JULY2015_FINAL_part3

English (1.16 MB - PDF)View document

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