CSL Bulk

Main information

  • Trade name:
  • CSL Bulk Human Coagulation Factor VIII 250 IU / von Willebrand factor 600 IU powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CSL Bulk Human Coagulation Factor VIII 250 IU / von Willebrand factor 600 IU powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214083
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214083

CSL Bulk Human Coagulation Factor VIII 250 IU / von Willebrand factor 600 IU powder for injection vial

ARTG entry for

Medicine Listed (Export Only)

Sponsor

CSL Behring Australia Pty Ltd

Postal Address

189-209 Camp Road,BROADMEADOWS, VIC, 3047

Australia

ARTG Start Date

2/09/2013

Product category

Medicine

Status

Active

Approval area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

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, other than condition No. 8 and condition No. 9.

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, other than condition No.11

The therapeutic goods grouped in this registration/listing as export only goods under the following names are included in the Australian Register of

Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. CSL Bulk Human Coagulation Factor VIII 250 IU / von Willebrand factor 600 IU powder for injection vial

Product Type

Single Medicine Product

Effective date

26/05/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

von Willebrand disease (VWD)

- Treatment of haemorrhage or prevention and treatment of surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is

ineffective or contraindicated.

Haemophilia A (congenital FVIII deficiency)

- Prophylaxis and treatment of bleeding in patients with haemophilia A.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1.

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

A white or pale yellow, hygroscopic powder or friable solid

Active Ingredients

Factor VIII

250 IU

Von willebrand factor

600 IU

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:37:42 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

© 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 26.11.2017 at 10:37:42 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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30-7-2018

Zalmoxis (MolMed S.p.A.)

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29-6-2018

EU/3/18/2040 (IQVIA RDS Ireland Limited)

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Europe -DG Health and Food Safety

27-6-2018

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

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2-6-2018

EU/3/14/1350 (Novartis Europharm Limited)

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29-5-2018

EU/3/18/2015 (Baxalta Innovations GmbH)

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Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1817 (IQVIA RDS Ireland Limited)

EU/3/16/1817 (IQVIA RDS Ireland Limited)

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Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety