Is Prazepam approved by the US FDA?

Drugs@FDA lists 4 application product lines for Prazepam, including CENTRAX (Discontinued); PRAZEPAM (Discontinued); PRAZEPAM (Discontinued); CENTRAX (Discontinued).

Are there safety signals or safety updates for Prazepam?

EMA PRAC: 1 entry (latest 2026-05-07).

Active substance

Prazepam

US FDA 4
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CENTRAX	5MG; 10MG; 20MG	capsule · oral	PARKE DAVIS	Discontinued	30 Nov 1979
PRAZEPAM	5MG	capsule · oral	USL PHARMA	Discontinued
PRAZEPAM	10MG	capsule · oral	USL PHARMA	Discontinued
CENTRAX	10MG	tablet · oral	PARKE DAVIS	Discontinued

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

All safety entries for prazepam →

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.