CAApproved

APO-NABILONE

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: NABILONE
Route: Oral
Dosage form: Capsule
Marketing holder: APOTEX INC
Catalog status: Approved
Source-reported status: Approved

Medicine name group

3 preserved variants

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

ApprovedCACurrent record

APO-NABILONE

NABILONE · 0.25 MG

Oral · Capsule

3 identifiers · Health Canada Drug Product Database

ApprovedCA

APO-NABILONE

NABILONE · 1 MG

Oral · Capsule

3 identifiers · Health Canada Drug Product Database

ApprovedCA

APO-NABILONE

NABILONE · 0.5 MG

Oral · Capsule

3 identifiers · Health Canada Drug Product Database

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

No governed active-ingredient link was found.

Condition reports

Multiple Sclerosis Parkinson Disease Alzheimer Disease Stress Disorders, Post-Traumatic Inflammatory Bowel Diseases

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

Health Canada

Approved

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.

37candidate study links

PHASE1COMPLETED

The Roles of Endocannabinoids in Insulin Secretion and Action

OTHER · Nabilone

Healthy Volunteers

PHASE1COMPLETED

The Roles of Endocannabinoids in Insulin Secretion and Action

OTHER · Nabilone

Healthy Volunteers

PHASE3RECRUITING

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Clinical Trial of Titrating Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder: Core Study With Safety Extension Phase

DRUG · Nabilone

Cannabis Withdrawal

PHASE2TERMINATED

Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia

DRUG · Nabilone

Frontotemporal Dementia · Frontotemporal Dementia, Behavioral Variant · Primary Progressive Aphasia · bvFTD · PPA · FTD

PHASE2TERMINATED

Impact of Chronic Nabilone Self-administration on Body Weight, Metabolic Markers, Gut Microbiota, and Neural Circuitry in Human Obesity

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 14.063495635986328

Nabilone

Matched from: NABILONE

Official RxNorm record

Identity candidate · score 13.50800895690918

nabilone Pill

Matched from: TEVA-NABILONE

Official RxNorm record

Identity candidate · score 13.033520698547363

nabilone Oral Product

Matched from: TEVA-NABILONE

Official RxNorm record

Identity candidate · score 12.202735900878906

nabilone Oral Capsule [Cesamet]

Matched from: TEVA-NABILONE

Official RxNorm record

Identity candidate · score 13.033520698547363

nabilone Oral Capsule

Matched from: TEVA-NABILONE

Official RxNorm record

Safety signals

Locally preserved FAERS reports

1,991reports

1,954reported 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

Health Canada Drug Product Database

02441497 · version 2026-06-23

Retrieved 20/08/2026, 10:36:56Verify at source