PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack

Main information

  • Trade name:
  • PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 191154
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

191154

PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Health Pty Ltd

Postal Address

Level 1 / 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

28/10/2011

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. PHARMACY ACTION Diarrhoea Relief loperamide hydrochloride 2mg capsule blister pack

Product Type

Single Medicine Product

Effective date

22/09/2015

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Symptomatic treatment of acute non-specific diarrhoea. Control and symptomatic treatment of chronic diarrhoea.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

12 capsules

(S2) Pharmacy Medicine

8 capsules

(S2) Pharmacy Medicine

6 capsules

(S2) Pharmacy Medicine

20 capsules

(S2) Pharmacy Medicine

10 capsules

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin capsule with grey cap and green body

Active Ingredients

Loperamide hydrochloride

2 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 28.11.2017 at 10:27:24 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