Active substance
Bromazepam
- SFDA 3
- Health Canada 4
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LEXOTANIL TAB. 3MG | 3 mg | Tablet · Oral use | 30 Bottle | SAR 17.05 | NCE · Prescription | CHEPLAPHARM Arzneimittel GmbH | Valid |
| LEXOTANIL TAB. 1.5 MG. | 1.5 mg | Tablet · Oral use | 30 Bottle | SAR 12.30 | NCE · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| LEXOTANIL TAB. 6 MG. | 6 mg | Tablet · Oral use | 30 Bottle | SAR 19.10 | NCE · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE MANIA; ANXIETY DISORDERS; SCHIZOPHRENIA; VERTIGO - BENIGN PAROXYSMAL POSITIONAL VERTIGO AND ACUTE VESTIBULAR NEURONITIS OR LABYRINTHITIS OR MENIERE'S DISEASE; VERTIGO - MOTION SICKNESS
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-BROMAZEPAM | 02177161 | 3 MG | TABLET · ORAL | APOTEX INC |
| APO-BROMAZEPAM | 02177188 | 6 MG | TABLET · ORAL | APOTEX INC |
| TEVA-BROMAZEPAM | 02230584 | 3 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-BROMAZEPAM | 02230585 | 6 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Safety signals and safety-related labeling changes
- EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No - EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.