NEUTROPEG pegfilgrastim 6 mg/0.6 mL solution for injection pre-filled syringe

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Pegfilgrastim
Available from:
Accord Healthcare Pty Ltd
Authorization status:
Registered
Authorization number:
308176

Public Summary

Summary for ARTG Entry:

308176

NEUTROPEG pegfilgrastim 6 mg/0.6 mL solution for injection pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

19/08/2019

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. NEUTROPEG pegfilgrastim 6 mg/0.6 mL solution for injection pre-filled syringe

Product Type

Single Medicine Product

Effective date

19/08/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as

manifested by febrile neutropenia.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1 prefilled syringe

(S4) Prescription Only Medicine

Components

1. NEUTROPEG pegfilgrastim 6 mg/0.6 mL solution for injection pre-filled syringe

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Clear and colourless liquid

Active Ingredients

Pegfilgrastim

6 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 30.08.2019 at 11:29:16 AEST

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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