IPTRAMOL tramadol hydrochloride 50mg capsule blister pack

Main information

  • Trade name:
  • IPTRAMOL tramadol hydrochloride 50mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IPTRAMOL tramadol hydrochloride 50mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 188378
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

188378

IPTRAMOL tramadol hydrochloride 50mg capsule 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

11/07/2012

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. IPTRAMOL tramadol hydrochloride 50mg capsule blister pack

Product Type

Single Medicine Product

Effective date

28/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Relief of moderate to severe pain

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. IPTRAMOL tramadol hydrochloride 50mg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

hard gelatin capsules, size 3, having green cap and yellow body filled with a

homogeneous white to off-white powder

Active Ingredients

Tramadol hydrochloride

50 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 01:34:34 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