PREGABALIN

Main information

  • Trade name:
  • PREGABALIN LUPIN pregabalin 20 mg/mL oral solution bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PREGABALIN LUPIN pregabalin 20 mg/mL oral solution bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215689
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215689

PREGABALIN LUPIN pregabalin 20 mg/mL oral solution bottle

ARTG entry for

Medicine Registered

Sponsor

Lupin Australia Pty Limited

Postal Address

Generic Health Pty Ltd,Level 1 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

5/12/2014

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. PREGABALIN LUPIN pregabalin 20 mg/mL oral solution bottle

Product Type

Single Medicine Product

Effective date

5/12/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Pregabalin Lupin is indicated for the treatment of neuropathic pain in adults.

Pregabalin Lupin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

6 Months

Store below 25

degrees Celsius

Child resistant closure

Do not Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. PREGABALIN LUPIN pregabalin 20 mg/mL oral solution bottle

Dosage Form

Oral Liquid, solution

Route of Administration

Oral

Visual Identification

A clear colorless liquid with characteristic banana odor.

Active Ingredients

Pregabalin

20 mg/mL

© 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 08:21:19 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

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