PHARMACOR OLANZAPINE 15 olanzapine 15 mg film-coated tablet in bottle pack

Main information

  • Trade name:
  • PHARMACOR OLANZAPINE 15 olanzapine 15 mg film-coated tablet in bottle pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PHARMACOR OLANZAPINE 15 olanzapine 15 mg film-coated tablet in bottle pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 178055
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

178055

PHARMACOR OLANZAPINE 15 olanzapine 15 mg film-coated tablet in bottle pack

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

23/03/2012

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. PHARMACOR OLANZAPINE 15 olanzapine 15 mg film-coated tablet in bottle pack

Product Type

Single Medicine Product

Effective date

23/03/2012

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses.,Olanzapine tablets alone or in combination with lithium or

valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.,Olanzapine tablets are also indicated for

preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

18 Months

Store below 25

degrees Celsius

Child resistant closure

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

100 Tablets in bottle pack

(S4) Prescription Only Medicine

Components

1. PHARMACOR OLANZAPINE 15 olanzapine 15 mg film-coated tablet in bottle pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light blue,elliptical, biconvex, film-coated tablets debossed with "O4" on

one side and plain on the other side.

Active Ingredients

Olanzapine

15 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 29.11.2017 at 10:45:56 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