DICLOFENAC Actavis diclofenac sodium 25mg enteric-coated tablet blister pack

Main information

  • Trade name:
  • DICLOFENAC Actavis diclofenac sodium 25mg enteric-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DICLOFENAC Actavis diclofenac sodium 25mg enteric-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 188548
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

188548

DICLOFENAC Actavis diclofenac sodium 25mg enteric-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

14/08/2012

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. DICLOFENAC Actavis diclofenac sodium 25mg enteric-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

13/07/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Inflammatory and degenerative forms of rheumatism; rheumatoid arthritis; osteoarthritis. Relief of acute or chronic pain states in which there is an

inflammatory component. Symptomatic treatment of primary dysmenorrhoea.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

18 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Blister Pack

PP/Al

18 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

50 tablets

(S4) Prescription Only Medicine

Components

1. DICLOFENAC Actavis diclofenac sodium 25mg enteric-coated tablet blister pack

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Brown yellow enteric-coated tablet, biconvex with an intact surface and

uniform colour.

Active Ingredients

Diclofenac sodium

25 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 01:10:50 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