Active substance
Trimebutine
- SFDA 1
- Health Canada 4
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| DEBRIDAT 1.2 GM-250ML SUSPENSION | 4.8 mg/ml | Suspension · Oral use | 1 Bottle | SAR 16.25 | NCE · Prescription | PARK-DAVIS | Withdrawn by MAH · Not Marketed |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-TRIMEBUTINE | 02245663 | 100 MG | TABLET · ORAL | APOTEX INC |
| APO-TRIMEBUTINE | 02245664 | 200 MG | TABLET · ORAL | APOTEX INC |
| MINT-TRIMEBUTINE | 02538202 | 100 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-TRIMEBUTINE | 02538210 | 200 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
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
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.