AusPAR: Propranolol hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Propranolol hydrochloride [PDF, 1.3 MB]

AusPAR: Propranolol hydrochloride [Word, 1.63 MB]

Attachment: Product Information: Propranolol hydrochloride [PDF, 253.23 KB]

Attachment: Product Information: Propranolol hydrochloride [Word, 176.24 KB]

Attachment: Extract from Clinical Evaluation Report: Propranolol hydrochloride [PDF, 3.86 MB]

Attachment: Extract from Clinical Evaluation Report: Propranolol hydrochloride [Word, 6.1 MB]

Device/Product Name

Hemangiol

Active ingredients

Propranolol hydrochloride

AusPAR Date

19 August 2015

Published

22 September 2015

Submission Number

PM-2013-01250-1-4

Submission Type

Major variation (extension of indications new dose form and strength)

Decision

Rejected (initial), Approved (final)