Active substance
Nitrazepam
- SFDA 1
- Health Canada 2
- NHS prices 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| DUMOLID TAB. 5 MG. | 5 mg | Tablet · Oral use | 24 Blister | SAR 5.20 | NCE · Prescription | XELLIA PHARMACEUTICAL APS | Withdrawn by MAH · Not Marketed |
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Nitrazepam 2.5mg/5ml oral suspension | £170.47 | 70 ml | 1 Oct 2026 |
| NHS Drug Tariff | Nitrazepam 5mg tablets | £1.89 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
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.