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Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)

We have adopted this International Scientific Guideline - CHMP/BPWP/410415/2011 Rev 1 

Last updated

About this guideline

Overseas effective date:  1 February 2016

Replaces: EMEA/CPMP/BPWG/283/00 Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular Use (adopted by TGA 12 March 2003)

Categories: Clinical efficacy and safety | Blood products (including biotech alternatives)

TGA Annotations: Nil
 

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.

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