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Guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis

We have adopted this International Scientific Guideline - CHMP/51230/2013 Corr.

Last updated

About this guideline

Overseas effective date: 1 September 2015

Replaces: EMEA/CHMP/EWP/604040/2009 Concept Paper on the Need for a Guideline on the Clinical Investigation of Medicinal Products Intended for Treatment of Systematic and Cutaneous Lupus Erythematosus (provided for information 26 March 2010)

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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