Regulatory PathRegulatory requirements compared

Active substance

Hyoscine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
TRANSDERM SCOP1MG/72HRsystem · transdermalBAXTER HLTHCARE CORPPrescription31 Dec 1979
SCOPOLAMINE1MG/72HRsystem · transdermalPADAGIS USPrescription30 Jan 2015
SCOPOLAMINE1MG/72HRsystem · transdermalMYLAN TECHNOLOGIESPrescription19 Jun 2019
SCOPOLAMINE1MG/72HRsystem · transdermalRICONPHARMA LLCPrescription24 Nov 2020
SCOPOLAMINE1MG/72HRsystem · transdermalACTAVIS LABS UT INCPrescription10 Jan 2022
SCOPOLAMINE1MG/72HRsystem · transdermalRHODES PHARMSPrescription6 May 2024
SCOPOLAMINE1MG/72HRsystem · transdermalZYDUS PHARMSPrescription29 Aug 2024
SCOPOLAMINE1MG/72HRsystem · transdermalAMNEALPrescription9 Jun 2025

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
SCOPOLAMINE HYDROBROMIDE INJECTION022428100.4 MG / MLLIQUID · INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUSJUNO PHARMA CANADA INC.
SCOPOLAMINE HYDROBROMIDE INJECTION022428110.6 MG / MLLIQUID · INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUSJUNO PHARMA CANADA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACSCOPOLAMINE 1 MG/3 DAY PATCH$4.33565per EA23 Sep 2026
NHS Drug TariffHyoscine hydrobromide 150microgram tablets£2.5012 tablet1 Oct 2026
NHS Drug TariffHyoscine hydrobromide 300microgram tablets£2.5012 tablet1 Oct 2026
NHS Drug TariffHyoscine hydrobromide 400micrograms/1ml solution for injection ampoules£22.7010 ampoule1 Oct 2026
NHS Drug TariffHyoscine hydrobromide 600micrograms/1ml solution for injection ampoules£224.1310 ampoule1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 2.3. Medicines for other common symptoms in palliative care · core
    Palliative care
    Local > Topical > Transdermal patch: 1 mg per 72 hours transdermal patch (EMLc) | Parenteral > General injections > unspecified: 400 µg per mL injection (EMLc); 600 µg per mL injection (EMLc)

Safety signals and safety-related labeling changes

  • US FDA 25 Apr 2025 TRANSDERM SCOP — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for hyoscine →

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.