INSTANYL

Main information

  • Trade name:
  • INSTANYL
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INSTANYL
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 197680
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

197680

INSTANYL fentanyl (as citrate) 50 microgram nasal spray single-dose bottle

ARTG entry for

Medicine Registered

Sponsor

Takeda Pharmaceuticals Australia Pty Ltd

Postal Address

GPO Box 2728,Sydney, NSW, 2001

Australia

ARTG Start Date

17/06/2013

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. INSTANYL

Product Type

Single Medicine Product

Effective date

17/06/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

6 bottles per carton

(S8) Controlled Drug

8 bottles per carton

(S8) Controlled Drug

10 bottles per carton

(S8) Controlled Drug

2 bottles per carton

(S8) Controlled Drug

Components

1.

Dosage Form

Spray, nasal

Route of Administration

Nasal

Visual Identification

Nasal spray

Active Ingredients

Fentanyl citrate

.785 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 28.11.2017 at 12:09:28 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