Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: GW Research Limited, Sovereign House, Vision Park, Chivers Way, Histon, Cambridge CB24 9BZ, United Kingdom, e-mail: medicalinfo@gwpharm.com
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 | Description | |
|---|---|---|
| Cannabidiol |
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 bottle is packaged in a carton with two 5 ml and two 1 ml calibrated oral dosing syringes (plunger HDPE and barrel polypropylene) and two 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.
GW Research Limited, Sovereign House, Vision Park, Chivers Way, Histon, Cambridge CB24 9BZ, United Kingdom, e-mail: medicalinfo@gwpharm.com
PLGB 36772/0001
Date of first authorisation: 19 September 2019
| Drug | Countries | |
|---|---|---|
| EPIDYOLEX | Austria, Australia, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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