PRIVIGEN

Main information

  • Trade name:
  • PRIVIGEN normal immunoglobulin (human) 40g (100g/L, 10%) solution for intravenous infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRIVIGEN normal immunoglobulin (human) 40g (100g/L, 10%) solution for intravenous infusion
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219160
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219160

PRIVIGEN normal immunoglobulin (human) 40g (100g/L, 10%) solution for intravenous infusion

ARTG entry for

Medicine Registered

Sponsor

CSL Behring Australia Pty Ltd

Postal Address

189-209 Camp Road,BROADMEADOWS, VIC, 3047

Australia

ARTG Start Date

17/06/2014

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. PRIVIGEN normal immunoglobulin (human) 40g (100g/L, 10%) solution for intravenous infusion

Product Type

Single Medicine Product

Effective date

11/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Replacement therapy for

Primary immunodeficiency diseases (PID),

Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections,

Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Immunomodulatory therapy for

Idiopathic thrombocytopenic purpura (ITP) in patients at high risk of bleeding or prior to surgery to correct the platelet count,

Guillain-Barr Syndrome (GBS),

Kawasaki disease,

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP),

Multifocal Motor Neuropathy (MMN),

Myasthenia Gravis (MG) exacerbations,

Lambert-Eaton Myasthenic Syndrome (LEMS),

Stiff Person Syndrome (SPS).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type II Clear

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

40 g: 400 mL solution in a 400 mL bottle

(S4) Prescription Only Medicine

Components

1. Normal Immunoglobulin (Human)

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear or slightly opalescent and colourless or pale yellow solution

Active Ingredients

normal immunoglobulin

40 g

© 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 19.10.2017 at 04:00:22 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

24-8-2018

Imagine recalls Buckyballs magnet sets

Imagine recalls Buckyballs magnet sets

Health Canada has determined that these magnet sets are a danger to human health and safety because they contain small powerful magnets which can be easily swallowed or inhaled by children. Unlike other small objects that would be more likely to pass normally through the digestive system if swallowed, when more than one small powerful magnet is swallowed, the magnets can attract one another while travelling through the digestive system. The magnets can then pinch together and create a blockage and slowly...

Health Canada

7-8-2018

Dollarama recalls the Skip Ball toy

Dollarama recalls the Skip Ball toy

The Skip Ball toy may contain levels of phthalates that exceed the allowable limit. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

Health Canada

23-5-2018

Do Teething Babies Need Medicine on Their Gums? No

Do Teething Babies Need Medicine on Their Gums? No

Teething is a normal part of childhood that doesn’t need a 'cure' with prescription or over-the-counter (OTC) medications. FDA warns parents that benzocaine products are not safe for treating teething in children. There are safer, non-toxic alternatives.

FDA - U.S. Food and Drug Administration

16-5-2018

FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

FDA - U.S. Food and Drug Administration

22-9-2016

Manufacturers and wholesale distributors must be contactable outside opening hours

Manufacturers and wholesale distributors must be contactable outside opening hours

The Danish Medicines Agency will make calls to companies' main phone numbers, or emergency lines, to check that wholesale distributors and pharmaceutical manufacturers are contactable outside normal opening hours and during holidays.

Danish Medicines Agency

4-6-2018

EU/3/05/334 (Florence Porte ThomE)

EU/3/05/334 (Florence Porte ThomE)

EU/3/05/334 (Active substance: Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein) - Transfer of orphan designation - Commission Decision (2018)3629 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/05/T/03

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2022 (Hanmi Europe Limited)

EU/3/18/2022 (Hanmi Europe Limited)

EU/3/18/2022 (Active substance: Glucagon analogue linked to a human immunoglobulin Fc fragment) - Orphan designation - Commission Decision (2018)3389 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/257/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2021 (Chemo Research S.L.)

EU/3/18/2021 (Chemo Research S.L.)

EU/3/18/2021 (Active substance: Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin) - Orphan designation - Commission Decision (2018)3388 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/17

Europe -DG Health and Food Safety