AusPAR: Lisdexamfetamine dimesilate

Australian Public Assessment Report

AusPAR

AusPAR: Lisdexamfetamine dimesilate [PDF, 1.17 MB]

AusPAR: Lisdexamfetamine dimesilate [Word, 1.41 MB]

Attachment: Product Information: Lisdexamfetamine dimesilate [PDF, 437.35 KB]

Attachment: Product Information: Lisdexamfetamine dimesilate [Word, 182.75 KB]

Attachment: Extract from Clinical Evaluation Lisdexamfetamine dimesilate [PDF, 2.78 MB]

Attachment: Extract from Clinical Evaluation Lisdexamfetamine dimesilate [Word, 6.21 MB]

Attachment: Extract from Clinical Evaluation Lisdexamfetamine dimesilate [PDF, 707.58 KB]

Attachment: Extract from Clinical Evaluation Lisdexamfetamine dimesilate [Word, 1.22 MB]

Device/Product Name

Vyvanse

Active ingredients

Lisdexamfetamine dimesilate

AusPAR Date

15 May 2018

Published

30 July 2018

Submission Number

PM-2016-01092-1-1

Submission Type

Major variation; new strength and extension of indications

Decision

Approved