ESAuthorised

EPIDYOLEX 100 MG/ML SOLUCION ORAL

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: VÍA ORAL
Dosage form: SOLUCIÓN ORAL, SOLUCIÓN/SUSPENSIÓN ORAL
Marketing holder: Jazz Pharmaceuticals Ireland Limited
Catalog status: Authorised
Source-reported status: Authorised

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.

1approval records

0source-reported patents

0exclusivity records

AEMPS

Authorised

Approval / market date · Not reported

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.

371candidate 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

DRUG · Full-Spectrum Cannabidiol (CBD)

Alcohol Use Disorder

PHASE2 · PHASE3RECRUITING

Randomized, Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Effects of Cannabidiol on Neurobehavioral and Function Outcomes in Sanfilippo Syndrome

DRUG · Epidiolex

Sanfilippo Syndrome · Mucopolysaccharidosis III

Source-reported use

Indications in regulatory records

No indication text was reported by the connected sources.

Medicine identity matching

RxNorm candidates

RxNorm normalizes identity; FAERS supplies non-causal post-market signals.

No RxNorm candidate was available in the latest local snapshot.

Safety signals

Locally preserved FAERS reports

23,265reports

13,754reported as serious

FAERS/AEMS reports are post-market signals. Counts do not establish causality or incidence and may contain duplicates or reporting bias.

Sources and provenance

Official source snapshots

AEMPS CIMA

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Retrieved 24/09/2026, 15:06:26Verify at source