ZIPRASIDONE-WT
Main information
- Trade name:
- ZIPRASIDONE-WT ziprasidone (as hydrochloride) 80 mg capsule blister pack
- Active ingredient:
- Ziprasidone hydrochloride
- Available from:
- Medis Pharma Pty Ltd
- INN (International Name):
- Ziprasidone hydrochloride
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 221097
- Last update:
- 08-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
221097
ZIPRASIDONE-WT ziprasidone (as hydrochloride) 80 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) 80 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) 80 mg capsule blister pack
Dosage Form
Capsule, hard
Route of Administration
Oral
Visual Identification
size 2 capsule: white body, blue cap
Active Ingredients
Ziprasidone hydrochloride
86.88 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 01:30:20 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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
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