Three requirements for a medicine

Epidyolex complies with the principal regulatory requirements for a medicine:1




Studied in randomised Phase III clinical trials, evaluating efficacy and dosing compared to placebo.




Generally well tolerated



Comprehensive pre-clinical programme examining toxicity, drug-drug interactions, pharmacology, dosing and abuse potential; as well as extensive clinical trials.







Manufactured to GxP standards and complies with regulatory medicine standards, ensuring:



  • Freedom from contaminants such as pesticides, heavy metals and aflatoxins
  • Batch-to-batch consistency
  • A stable shelf life
  • Continuous investment in process and facilities


GxP, Good Practice.





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1. Epidyolex Summary of Product Characteristics (Date accessed: April 2021).