CSL Malaysia

Main information

  • Trade name:
  • CSL Malaysia Intragam P Normal Immunoglobulin (Human) 6% w/v (60 g/L) Solution for Intravenous Use
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CSL Malaysia Intragam P Normal Immunoglobulin (Human) 6% w/v (60 g/L) Solution for Intravenous Use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219007
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219007

CSL Malaysia Intragam P Normal Immunoglobulin (Human) 6% w/v (60 g/L) Solution for Intravenous Use

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

8/01/2014

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.

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 Malaysia Intragam P Normal Immunoglobulin (Human) 6% w/v (60 g/L) Solution for Intravenous Use

Product Type

Single Medicine Product

Effective date

19/05/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Intragam P is indicated for replacement IgG therapy in:

* primary immunodeficiency (PID);

* myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections;

* congenital or acquired immune deficiency syndrome with with recurrent infections;

* congenital or acquired immune deficiency syndrome with recurrent infections.

Intragam P is indicated for immunomodulatory therapy in:

* Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count;

* allogeneic bone marrow transplantation;

* Kawasaki disease;

* Guillain-Barre Syndrome (GBS).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Not recorded

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

50 mL

(S1) This Schedule is intentionally blank

Components

1.

Dosage Form

Injection, solution

Route of Administration

Intravenous Infusion

Visual Identification

A clear or slightly opalescent and colourless or pale yellow liquid.

Active Ingredients

normal immunoglobulin

3 g

Public Summary

Page 1 of

Produced at 23.11.2017 at 08:29:12 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 23.11.2017 at 08:29:12 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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