Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Jazz Pharmaceuticals Ireland Ltd, 5 th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland
Epidyolex 100 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, colourless to yellow solution. |
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
0.0003 mg benzyl alcohol
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Cannabidiol is indicated for the treatment of seizures associated with Lennox‑Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. |
| List of Excipients |
|---|
|
Refined sesame oil |
Amber glass bottle (type III) with a child-resistant and tamper-evident screw cap (polypropylene).
The following pack sizes are available for Epidyolex 100 mg/ml oral solution:
100 ml (1 × 100 ml bottle) with 2 × 5 ml and 2 × 1 ml calibrated oral dosing syringes (HDPE plunger and Polypropylene barrel) and two bottle adaptors (LDPE).
300 ml (3 × 100 ml bottles) with 2 × 5 ml and 2 × 1 ml calibrated oral dosing syringes (HDPE plunger and Polypropylene barrel) and three bottle adaptors (LDPE).
The 5 ml syringes are graduated in 0.1 ml increments and the 1 ml syringes are graduated in 0.05 ml increments.
Not all pack sizes may be marketed.
Jazz Pharmaceuticals Ireland Ltd, 5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland
EU/1/19/1389/001
EU/1/19/1389/002
Date of first authorisation: 19 September 2019
Date of latest renewal: 26 July 2024
| Drug | Countries | |
|---|---|---|
| EPIDYOLEX | Austria, Australia, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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