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Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing

We have adopted this International Scientific Guideline - EMA/CHMP/336243/2013

Last updated

About this guideline

Overseas effective date:  1 January 2016

Replaces: EMA/CHMP/462198/2012 Concept paper on the need of a guideline for clinical investigation of medicinal products for the treatment of chronic constipation (provided for information 1 August 2014)

Categories: Clinical efficacy and safety | Alimentary tract and metabolism

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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