Regulatory PathRegulatory requirements compared

Active substance

Carbachol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
MIOSTAT0.01%solution · intraocularALCONPrescription28 Sep 1972
CARBASTAT0.01%solution · intraocularNOVARTISDiscontinued28 Apr 1995
CARBACHOL0.01%solution · intraocularPHARMAFAIRDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MIOSTAT OPHTHALMIC LIQ 0.01%000425440.01 %SOLUTION · INTRAOCULARALCON CANADA INC

WHO WHO Model List of Essential Medicines (2025)

  • 21.4. Ophthalmological preparations > Miotics and antiglaucoma medicines · core
    Therapeutic equivalent to pilocarpine for Acute angle closure with pupillary block; Therapeutic equivalent to pilocarpine for Ocular hypertension; Therapeutic equivalent to pilocarpine for Primary open-angle glaucoma

Safety signals and safety-related labeling changes

All safety entries for carbachol →

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.