AusPAR: Labetalol hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Labetalol hydrochloride [PDF, 306.36 KB]

AusPAR: Labetalol hydrochloride [Word, 359.98 KB]

Attachment 1: Product Information for Labetalol hydrochloride – SXP [PDF, 220.69 KB]

Attachment 1: Product Information for Labetalol hydrochloride – SXP [Word, 48.51 KB]

Attachment 2: Product Information for Labetalol hydrochloride – RMB [PDF, 220.95 KB]

Attachment 2: Product Information for Labetalol hydrochloride – RMB [Word, 48.58 KB]

Attachment 3: Product Information for Labetalol hydrochloride - TLB [PDF, 220.91 KB]

Attachment 3: Product Information for Labetalol hydrochloride - TLB [Word, 48.34 KB]

Device/Product Name

Labetalol SXP/RMB/TLB

Active ingredients

Labetalol hydrochloride

AusPAR Date

19 March 2021

Published

12 April 2021

Submission Number

PM-2018-01753-1-3

Submission Type

Extension of indications and new dosage form

Decision

Approved