Regulatory PathRegulatory requirements compared

Active substance

Salmeterol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
SEREVENTEQ 0.05MG BASE/INHpowder · inhalationGLAXOSMITHKLINEPrescription19 Sep 1997
SEREVENTEQ 0.021MG BASE/INHaerosol, metered · inhalationGLAXOSMITHKLINEDiscontinued4 Feb 1994

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
SEREVENT DISKUS (50MCG/DOSE)0223112950 MCG / ACTPOWDER · INHALATIONGLAXOSMITHKLINE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACSEREVENT DISKUS 50 MCG$6.74459per EA23 Sep 2026
NHS Drug TariffSalmeterol 25micrograms/dose inhaler CFC free£29.26120 dose1 Oct 2026
NHS Drug TariffSalmeterol 50micrograms/dose dry powder inhaler£35.1160 dose1 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

  • US FDA 9 Jul 2021 AIRDUO RESPICLICK — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Jul 2019 SEREVENT — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Jan 2019 ADVAIR DISKUS 100/50 — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Jan 2019 ADVAIR DISKUS 250/50 — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Jan 2019 ADVAIR DISKUS 500/50 — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Jan 2019 ADVAIR HFA — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for salmeterol →

Combinations containing Salmeterol

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.