IDELVION albutrepenonacog alfa 3500 IU powder (and diluent) for injection

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

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Active ingredient:
Factor IX
Available from:
CSL Behring Australia Pty Ltd
Authorization status:
Registered
Authorization number:
324220

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Public Summary

Summary for ARTG Entry:

324220

IDELVION albutrepenonacog alfa 3500 IU powder (and diluent) for injection

ARTG entry for

Medicine Registered

Sponsor

CSL Behring Australia Pty Ltd

Postal Address

189-209 Camp Road, BROADMEADOWS, VIC, 3047

Australia

ARTG Start Date

19/11/2020

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 . IDELVION albutrepenonacog alfa 3500 IU powder (and diluent) for injection

Product Type

Composite Pack

Effective Date

19/11/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

IDELVION is indicated in all patients with haemophilia B for:,·Routine prophylaxis to prevent or reduce the frequency of bleeding episodes,·Control

and prevention of bleeding episodes,·Control and prevention of bleeding in the perioperative setting.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

30 Months

Store between 2 - 25

degrees celsius

Not recorded

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

3500 IU

Not scheduled. Not considered by committee

Components

1 . Water for injection

Dosage Form

Solution

Route of Administration

Intravenous

Visual Identification

Clear solution

Active Ingredients

purified water

5 mg

Other Ingredients (Excipients)

Public Summary

Page 1 of

Produced at 13.01.2021 at 12:37:38 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

2 . IDELVION albutrepenonacog alfa 3500 IU powder (and diluent) for injection

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

A pale yellow to white lyophilised powder

Active Ingredients

Factor IX

3500 IU

Other Ingredients (Excipients)

mannitol

polysorbate 80

sodium citrate dihydrate

sucrose

© 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 2 of

Produced at 13.01.2021 at 12:37:38 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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