USSubmitted label - approval not established

LEAFPRO CBDMED OIL FS QP 3% (CANNABIDIOL) OIL

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

Submitted product label. A product label is preserved locally, but approval or current marketing status is not established.

Product data

Locally preserved regulatory fields

Active ingredients: cannabidiol
Route: Not reported
Dosage form: Not reported
Marketing holder: LEAFMED GMBH
Catalog status: Submitted label - approval not established
Source-reported status: Not reported

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.

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.

Identity candidate · score 13.754777659530639

RxNorm concept

Matched from: LEAFPRO CBDMED OIL FS QP 3% (CANNABIDIOL) OIL

Official RxNorm record

Identity candidate · score 12.993089755249022

fluocinolone acetonide Topical Oil [Derma-Smoothe FS]

Matched from: LEAFPRO CBDMED OIL FS QP 3% (CANNABIDIOL) OIL

Official RxNorm record

Identity candidate · score 12.993089755249022

Derma-Smoothe/FS 0.01 % Topical Oil

Matched from: LEAFPRO CBDMED OIL FS QP 3% (CANNABIDIOL) OIL

Official RxNorm record

Identity candidate · score 12.758531255645277

cannabidiol Oral Solution

Matched from: cannabidiol

Official RxNorm record

Identity candidate · score 17.158288955688477

CANNABIDIOL OIL

Matched from: LEAFPRO CBDMED OIL FS QP 3% (CANNABIDIOL) OIL

Official RxNorm record

Identity candidate · score 14.54064775466919

RxNorm concept

Matched from: LEAFPRO CBDMED OIL FS QP 3% (CANNABIDIOL) OIL

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

DailyMed structured labels

9f5071ef-2f9c-dd37-e053-2995a90afc9c · version 1

Retrieved 22/08/2026, 21:20:19Verify at source

Locally preserved regulatory fields

Related local records

Cannabinoids and active compounds

Condition reports

Approval, patents and exclusivity

Related registered studies

Indications in regulatory records

RxNorm candidates

RxNorm concept

fluocinolone acetonide Topical Oil [Derma-Smoothe FS]

Derma-Smoothe/FS 0.01 % Topical Oil

cannabidiol Oral Solution

CANNABIDIOL OIL

RxNorm concept

Locally preserved FAERS reports

Official source snapshots

DailyMed structured labels

cannabidiol Oral Product

Cannabidiolic acid

CANNABIDIOL 20 mg ORAL CAPSULE, LIQUID FILLED [leafPro CBDmed Softgels T-FS QD 20]

cannabidiol Oral Liquid Product

CANNABIDIOL 5 g in 100 mL ORAL OIL [leafPro CBDmed Oil FS QP 5%]

CANNABIDIOL 20 g in 100 mL ORAL OIL [leafPro CBDmed Oil FS QP 20%]

RxNorm concept

fluocinolone Topical Oil [Derma-Smoothe FS]

CANNABIDIOL 3 g in 100 mL ORAL OIL [leafPro CBDmed Oil FS QP 3%]

CANNABIDIOL 20 g in 100 mL ORAL OIL [leafPro CBDmed Oil T-FS QD 20%]

CANNABIDIOL 20 mg ORAL CAPSULE, LIQUID FILLED [leafPro CBDmed Softgels FS QP 20]

CANNABIDIOL 5 g in 100 mL ORAL OIL [leafPro CBDmed Oil T-FS QD 5%]

CANNABIDIOL 3 g in 100 mL ORAL OIL [leafPro CBDmed Oil T-FS QD 3%]