Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS CONFIDENTIAL2 1. NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg cannabidiol. Excipients with known effect Each ml of solution contains: 79 mg anhydrous ethanol 736 mg refined sesame oil mg benzyl alcohol For the full list of excipients, see section 3. PHARMACEUTICAL FORM Oral solution Clear, colourless to yellow solution 4.
the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other concurrent therapy (see sections 4.4 under hepatocellular injury and 5.2).
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