Active substance
Loprazolam
- UK MHRA 2
- NHS prices 1
- Safety 1
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| LOPRAZOLAM 1MG TABLETS | PL 17780/0306 | ZENTIVA PHARMA UK LIMITED | POM |
| LOPRAZOLAM 1MG TABLETS | PL 20046/0295 | FOCUS PHARMACEUTICALS LIMITED | POM |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Loprazolam 1mg tablets | £15.34 | 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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.