Summary for ARTG Entry:
PRIVIGEN normal immunoglobulin (human) 40g (100g/L, 10%) solution for intravenous infusion
ARTG entry for
CSL Behring Australia Pty Ltd
189-209 Camp Road,BROADMEADOWS, VIC, 3047
ARTG Start Date
Drug Safety Evaluation Branch
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.
1. PRIVIGEN normal immunoglobulin (human) 40g (100g/L, 10%) solution for intravenous infusion
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
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),
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
Glass Type II Clear
Store below 25
Protect from Light
Do not Freeze
Pack Size/Poison information
40 g: 400 mL solution in a 400 mL bottle
(S4) Prescription Only Medicine
1. Normal Immunoglobulin (Human)
Route of Administration
Clear or slightly opalescent and colourless or pale yellow solution
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Produced at 19.10.2017 at 04:00:22 AEDT
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