EUAuthorised

Epidyolex

This is a locally preserved regulatory record. Source labeling does not by itself prove efficacy for a condition.

Regulatory product record. The connected regulator reports this product as approved, authorised or currently marketed.

Product data

Locally preserved regulatory fields

Active ingredients: cannabidiol
Route: Not reported
Dosage form: Not reported
Marketing holder: Jazz Pharmaceuticals Ireland Limited
Catalog status: Authorised
Source-reported status: Authorised

Medicine name group

2 preserved variants

Records share the same exact normalized name. Different identifiers, strengths, countries, presentations and statuses remain separate.

AuthorisedEUCurrent record

Epidyolex

Strength not reported

Route and form not reported

2 identifiers · EMA medicines

Status not establishedMULTI

Epidyolex

Strength not reported

orale · solution buvable

4 identifiers · EU Union Register of medicinal products · French Public Database of Medicines

Linked local records

Related local records

Substance links use source-reported active ingredients. Condition links come from registered study context and are not efficacy claims.

Cannabinoids and active compounds

cannabidiol

Condition reports

epilepsy Chronic Pain Multiple Sclerosis Parkinson Disease Alzheimer Disease Anxiety Disorders Cancer Pain Stress Disorders, Post-Traumatic Opioid-Related Disorders Alcoholism Bipolar Disorder

Regulatory record

Approval, patents and exclusivity

Patent and exclusivity fields are preserved from the regulator. They are not a legal opinion and are separate from clinical development.

0approval records

0source-reported patents

0exclusivity records

Clinical development

Related registered studies

Phases and statuses are source-reported study stages matched by governed token phrases. They do not prove medicine identity, approval or efficacy.

372candidate study links

PHASE4NOT_YET_RECRUITING

A Phase 3b/4, Interventional, Prospective, Multicenter, Open-Label Study Evaluating the Effectiveness of a Gradual Titration Regimen to Optimize CBD-OS as Add-On Therapy in Adults With Lennox-Gastaut Syndrome

DRUG · Cannabidiol Oral Solution

Lennox-Gastaut Syndrome

PHASE2RECRUITING

Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).

DRUG · Cannabidiol Administered as Nantheia ATL5

PTSD

PHASE2RECRUITING

Efficacy and Safety of Cannabidiol for Pain Relief of Patients With End-stage Metastatic Castration Resistant Prostate Cancer - a Randomised Double-blinded Placebo-controlled Phase II Trial

DRUG · Cannabidiol

Metastatic Castration Resistant Prostate Cancer (mCRPC)

PHASE2RECRUITING

Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine

DRUG · Broad-Spectrum Cannabidiol (CBD)

Alcohol Use Disorder

PHASE2RECRUITING

Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine

Source-reported use

Indications in regulatory records

Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.

Medicine identity matching