PIP-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack

Main information

  • Trade name:
  • PIP-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PIP-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195320
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195320

PIP-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Ipca Pharma (Australia) Pty Ltd

Postal Address

6 Morotai Avenue,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

12/02/2013

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. PIP-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack

Product Type

Single Medicine Product

Effective date

19/02/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of children aged 6 years and older and adolescents with obsessive compulsive disorder. ,Treatment of major depression, obsessive

compulsive disorder and panic disorder in adults. Treatment of social phobia (social anxiety disorder) and the prevention of its relapse in

adults.,Treatment of premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

48 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

112 tablets

(S4) Prescription Only Medicine

120 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

14 tablets

(S4) Prescription Only Medicine

20 tablets

(S4) Prescription Only Medicine

28 tablets

(S4) Prescription Only Medicine

30 tablets

(S4) Prescription Only Medicine

56 tablets

(S4) Prescription Only Medicine

60 tablets

(S4) Prescription Only Medicine

84 tablets

(S4) Prescription Only Medicine

100 tablets

(S4) Prescription Only Medicine

Components

1. PIP-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, capsule shaped, biconvex film coated tablets with '100'

and 'BL' embossed on one side.

Active Ingredients

Sertraline hydrochloride

111.9 mg

Public Summary

Page 1 of

Produced at 28.11.2017 at 04:46:52 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

© 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 2 of

Produced at 28.11.2017 at 04:46:52 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