FENTANYL WATSON 100 fentanyl 100 mcg/hr transdermal patch pouch

Main information

  • Trade name:
  • FENTANYL WATSON 100 fentanyl 100 mcg/hr transdermal patch pouch
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FENTANYL WATSON 100 fentanyl 100 mcg/hr transdermal patch pouch
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 190798
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

190798

FENTANYL WATSON 100 fentanyl 100 mcg/hr transdermal patch pouch

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

28/08/2012

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. FENTANYL WATSON 100 fentanyl 100 mcg/hr transdermal patch pouch

Product Type

Single Medicine Product

Effective date

5/02/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Management of chronic pain requiring opioid analgesia.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Other plastic

laminate/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

5 patches

(S8) Controlled Drug

Components

1. FENTANYL WATSON 100 fentanyl 100 mcg/hr transdermal patch

Dosage Form

Drug delivery system, transdermal

Route of Administration

Transdermal

Visual Identification

Rectangular, round cornered, transparent and colourless patch with 30 cm2

active surface area contained in a protective pouch made from composite

foil.

Active Ingredients

Fentanyl

16.5 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 10:43:19 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