AusPAR: Diltiazem hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Diltiazem hydrochloride [PDF, 535.06 KB]

AusPAR: Diltiazem hydrochloride [Word, 432.53 KB]

Attachment: Extract from Clinical Evaluation Report: Diltiazem hydrochloride [PDF, 567.93 KB]

Attachment: Extract from Clinical Evaluation Report: Diltiazem hydrochloride [Word, 678.55 KB]

Device/Product Name

Ano-Cream

Active ingredients

Diltiazem hydrochloride

AusPAR Date

10 May 2017

Published

22 June 2017

Submission Number

PM-2015-01099-1-1

Submission Type

Major variation (new dosage form)

Decision

Rejected