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Panvax® H1N1 Approval For Registration For Use in Australia by Therapeutic Goods Administration

Panvax® H1N1 Approval For Registration For Use in Australia by Therapeutic Goods Administration

Melbourne, Australia — 18/09/2009

CSL Biotherapies, a subsidiary of CSL Limited, Australia's leading biopharmaceutical company, can today confirm that its vaccine against the pandemic (H1N1) 2009 influenza or 'swine flu' has been approved registration for use in people aged 10 years and over. The TGA assesses safety, efficacy and quality when arriving at the decision to register a medical product for use by the general public. 

The TGA, Australia’s regulator of drugs and medical devices, has registered the vaccine after an assessment of the clinical trial results demonstrating that a single standard 15mcg dose produces a strong immune response against the swine flu in over 95% of healthy adults, and that side-effects are similar to those experienced with the seasonal flu vaccine. The most commonly reported side effects were injection site tenderness, headache and injection site pain.1 This approval paves the way for a Government program to immunise Australians against the influenza pandemic.


Download the Release:
PDF icon Panvax® H1N1 Approval For Registration For Use in Australia by Therapeutic Goods Administration (0.04MB)

Download the Product Information:
Panvax® H1N1 / Panvax® H1N1 Junior Vaccine Product Information (0.12Mb)


Media Contact:

Dr Rachel David
Director, Public Affairs
CSL Biotherapies
Mobile: 0401 775 779
Email: rachel.david@csl.com.au


Panvax® H1N1 is a registered trademark of CSL Ltd

* Panvax® H1N1 has been licensed for use in the prevention of pandemic(H1N1) 2009 influenza; however its availability to the Australian public will depend upon the Department of Health and Ageing approving an immunisation program against the disease.

1 Greenberg etal’ Response after One Dose of a Monovalent Influenza A (H1N1) Vaccine – Preliminary Report’ NEJM September 10, 2009

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