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AusPAR: Dabigatran etexilate

Australian Public Assessment Report

AusPAR

AusPAR Dabigatran etexilate [PDF, 1.75 MB]

AusPAR Dabigatran etexilate [Word, 3.4 MB]

Attachment: Product Information: Dabigatran etexilate [PDF, 626.19 KB]

Attachment: Product Information: Dabigatran etexilate [Word, 745 KB]

Attachment: Extract from Clinical Evaluation Report: Dabigatran etexilate [PDF, 3.49 MB]

Attachment: Extract from Clinical Evaluation Report: Dabigatran etexilate [Word, 7.64 MB]

Device/Product Name

Pradaxa

Active ingredients

Dabigatran etexilate

AusPAR Date

4 January 2016

Published

11 February 2016

Submission Number

PM-2013-02038-1-3

Submission Type

Major variation (extension of indications)

Decision

Approved