Nuwiq, Human cell line recombinant human factor VIII (Human-cl rhFVIII) 4000 IU powder and solvent for solution for injection. V

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

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Active ingredient:
simoctocog alfa
Available from:
Octapharma Australia Pty Ltd
Authorization status:
Registered
Authorization number:
323189

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Public Summary

Summary for ARTG Entry:

323189

Nuwiq Human cell line recombinant human factor VIII (Human-cl rhFVIII) 4000 IU powder and solvent for

solution for injection

ARTG entry for

Medicine Registered

Sponsor

Octapharma Australia Pty Ltd

Postal Address

Jones Bay Wharf 42/26-32 Pirrama Road, PYRMONT, NSW, 2009

Australia

ARTG Start Date

12/11/2020

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 . Nuwiq, Human cell line recombinant human factor VIII (Human-cl rhFVIII) 4000 IU powder and solvent for

solution for injection. Vial of powder and prefilled WFI syringe

Product Type

Single Medicine Product

Effective Date

12/11/2020

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

Treatment and prophylaxis of bleeding (also during and after surgery) in previously treated paediatric (>= 2 years) and adult patients with haemophilia A

(congenital factor VIII deficiency).

Nuwiq does not contain von Willebrand Factor and is thus not indicated to treat von Willebrand's Disease.

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

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

exempt from scheduling - Appendix A; prescription medicine

Components

1 .

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

Nuwiq - white to off-white lyophilised powder,WFI - clear, colourless liquid

Active Ingredients

simoctocog alfa

4000 IU

Public Summary

Page 1 of

Produced at 13.01.2021 at 01:45:03 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

Other Ingredients (Excipients)

arginine hydrochloride

calcium chloride dihydrate

poloxamer

sodium chloride

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 01:45:03 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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