Active substance
Methacholine
- US FDA 2
- Health Canada 4
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROVOCHOLINE | 100MG/VIAL | for solution · inhalation | METHAPHARM | Prescription | 31 Oct 1986 |
| PROVOCHOLINE | 1600MG/VIAL | for solution · inhalation | METHAPHARM | Discontinued | 31 Oct 1986 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| METHACHOLINE OMEGA | 02263912 | 1600 MG / VIAL | POWDER FOR SOLUTION · INHALATION | OMEGA LABORATORIES LIMITED |
| PROVOCHOLINE | 02239656 | 100 MG / VIAL | POWDER FOR SOLUTION · INHALATION | METHAPHARM INC |
| PROVOCHOLINE | 02243834 | 1280 MG / VIAL | POWDER FOR SOLUTION · INHALATION | METHAPHARM INC |
| PROVOCHOLINE | 02288826 | 1600 MG / VIAL | POWDER FOR SOLUTION · INHALATION | METHAPHARM INC |
Safety signals and safety-related labeling changes
- US FDA 6 Jun 2026 PROVOCHOLINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.