Active substance
Propantheline
- US FDA 13
- NHS prices 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PRO-BANTHINE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | SHIRE | Discontinued | 2 Apr 1953 |
| PROPANTHELINE BROMIDE | 7.5MG; 15MG | tablet · oral | HIKMA PHARMS | Discontinued | 9 Sep 1974 |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | WATSON LABS | Discontinued | 15 Jan 1975 |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | PVT FORM | Discontinued | 4 Aug 1976 |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | PAR PHARM | Discontinued | 25 Oct 1993 |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | SANDOZ | Discontinued | |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | WATSON LABS | Discontinued | |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | MYLAN | Discontinued | |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | TABLICAPS | Discontinued | |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | IMPAX LABS | Discontinued | |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | HEATHER | Discontinued | |
| PROPANTHELINE BROMIDE | 15MG | tablet · oral | ASCOT | Discontinued | |
| PRO-BANTHINE | 30MG/VIAL | injectable · injection | GD SEARLE LLC | Discontinued |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Propantheline bromide 15mg tablets | £20.74 | 112 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.