EPIDYOLEX

This brand name is authorized in Australia, Austria, Croatia, Estonia, Finland, France, Ireland, Italy, Lithuania, Poland, Romania, UK.

Active ingredients

The drug EPIDYOLEX contains one active pharmaceutical ingredient (API):

1
UNII 19GBJ60SN5 - 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.

 
Read more about Cannabidiol

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 EPIDYOLEX Oral solution MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
N03AX24 N Nervous system → N03 Antiepileptics → N03A Antiepileptics → N03AX Other antiepileptics
Discover more medicines within N03AX24

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 12467E
EE Ravimiamet 1801460, 1849866
FI Lääkealan turvallisuus- ja kehittämiskeskus 400959
FR Base de données publique des médicaments 61680130
GB Medicines & Healthcare Products Regulatory Agency 380299
IE Health Products Regulatory Authority 89117
IT Agenzia del Farmaco 048251019
LT Valstybinė vaistų kontrolės tarnyba 1088498
PL Rejestru Produktów Leczniczych 100417524
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W69656001

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