ZIPRASIDONE-WT ziprasidone (as hydrochloride) 60 mg capsule blister pack

Main information

  • Trade name:
  • ZIPRASIDONE-WT ziprasidone (as hydrochloride) 60 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZIPRASIDONE-WT ziprasidone (as hydrochloride) 60 mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 221084
  • Last update:
  • 19-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221084

ZIPRASIDONE-WT ziprasidone (as hydrochloride) 60 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

5/03/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ZIPRASIDONE-WT ziprasidone (as hydrochloride) 60 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

23/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy;,as

monotherapy for the short term treatment of acute manic or mixed episodes associated with bipolar I disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

36 Months

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. ZIPRASIDONE-WT ziprasidone (as hydrochloride) 60 mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

size 3 capsule: white body, white cap

Active Ingredients

Ziprasidone hydrochloride

65.16 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 01:32:40 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information