Regulatory PathRegulatory requirements compared

Active substance

Ciclesonide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ALVESCO 160MCG-PUFF INHALER160 µgPressurised inhalation, solution · Inhalation use1 InhalerSAR 52.70NCE · PrescriptionTAKEDA GMBHWithdrawn by MAH · Not Marketed
ALVESCO 160MCG-PUFF INHALER160 µgPressurised inhalation, solution · Inhalation use1 InhalerSAR 105.45NCE · PrescriptionTAKEDA GMBHWithdrawn by MAH · Not Marketed
ALVESCO 80MCG-PUFF INHALER80 µgPressurised inhalation, solution · Inhalation use1 InhalerSAR 63.00NCE · PrescriptionTAKEDA GMBHWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
OMNARIS0.05MG/SPRAYspray, metered · nasalAZURITYPrescription20 Oct 2006
OMNARIS50MCGspray · nasalNYCOMED US INCPrescription21 Nov 2007
ALVESCO0.08MG/INH; 0.16MG/INHaerosol, metered · inhalationAZURITYPrescription10 Jan 2008
ZETONNA0.037MG/INHaerosol, metered · nasalAZURITYDiscontinued20 Jan 2012

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ALVESCO02285606100 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONCOVIS PHARMA GMBH
ALVESCO02285614200 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONCOVIS PHARMA GMBH
OMNARIS0230367150 MCG / ACTSPRAY (METERED-DOSE) · NASALCOVIS PHARMA GMBH

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACALVESCO 160 MCG INHALER$42.97099per GM23 Sep 2026
US NADACALVESCO 80 MCG INHALER$42.95871per GM23 Sep 2026
US NADACOMNARIS 50 MCG NASAL SPRAY$22.5531per GM23 Sep 2026
NHS Drug TariffCiclesonide 160micrograms/dose inhaler CFC free£38.62120 dose1 Oct 2026
NHS Drug TariffCiclesonide 80micrograms/dose inhaler CFC free£32.83120 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.

WHO WHO Model List of Essential Medicines (2025)

  • 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
    Therapeutic equivalent to budesonide for Asthma

Safety signals and safety-related labeling changes

All safety entries for ciclesonide →

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.