ESAuthorised

SATIVEX 2,7 MG/2,5 MG SOLUCION PARA PULVERIZACION BUCAL

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: DRONABINOL, CANNABIDIOL
Route: Vía bucal (buccal use)
Dosage form: SOLUCIÓN PARA PULVERIZACIÓN BUCAL, PULVERIZACION BUCAL
Marketing holder: Cnx Therapeutics 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 Delta(9)-tetrahydrocannabinol

Condition reports

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

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.

509candidate 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

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 5 mg dronabinol + 125 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

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

31,165reports

19,660reported 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

72544 · version f6dfadbfc2fc8d1280733f26d77b70c7b3a88ca4c55aacb8050689bc25e923bd

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