Is Fluticasone + Salmeterol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 19 valid registrations of Fluticasone + Salmeterol, including COMBIWAVE (50,25 µg,µg, Pressurised inhalation, SAR 36.75); COMBIWAVE (125,25 µg,µg, Pressurised inhalation, SAR 44.50); COMBIWAVE (250,25 µg,µg, Pressurised inhalation, SAR 64.40); Combiwave Instahaler (50,500 µg,µg, Inhalation powder, SAR 141.75); Combiwave Instahaler (50,250 µg,µg, Inhalation powder, SAR 107.50).

Is Fluticasone + Salmeterol approved by the US FDA?

Drugs@FDA lists 11 application product lines for Fluticasone + Salmeterol, including ADVAIR DISKUS 100/50 (Prescription); ADVAIR DISKUS 250/50 (Prescription); ADVAIR DISKUS 500/50 (Prescription); ADVAIR HFA (Prescription); AIRDUO RESPICLICK (Prescription).

Is Fluticasone + Salmeterol authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fluticasone + Salmeterol: Seffalair Spiromax.

Active substances

Fluticasone + Salmeterol

SFDA 28
US FDA 11
EMA 4
Health Canada 11
US price lines 18
NHS prices 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
COMBIWAVE	50,25 µg,µg	Pressurised inhalation · Inhalation use	1 Pressurised container	SAR 36.75	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
COMBIWAVE	125,25 µg,µg	Pressurised inhalation · Inhalation use	1 Pressurised container	SAR 44.50	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
COMBIWAVE	250,25 µg,µg	Pressurised inhalation · Inhalation use	1 Pressurised container	SAR 64.40	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Combiwave Instahaler	50,500 µg,µg	Inhalation powder · Inhalation use	1 Multidose container	SAR 141.75	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Combiwave Instahaler	50,250 µg,µg	Inhalation powder · Inhalation use	1 Multidose container	SAR 107.50	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Combiwave Instahaler	50,100 µg,µg	Inhalation powder · Inhalation use	1 Multidose container	SAR 76.15	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
ROLENIUM 250/50 mcg Elpenhaler	250,50 µg,µg	Inhalation powder, pre-dispensed · Inhalation use	1 Inhaler	SAR 120.85	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
ROLENIUM 500/50 mcg Elpenhaler	500,50 µg,µg	Inhalation powder, pre-dispensed · Inhalation use	1 Inhaler	SAR 159.40	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
SERETIDE DISKUS	250,50 µg,µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 126.45	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
SERETIDE DISKUS	100,50 µg,µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 89.60	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
SERETIDE DISKUS 50\500 MCG	500,50 µg,µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 166.75	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
SERETIDE EVOHALER	250,25 µg,µg	Pressurised inhalation, suspension · Inhalation use	1 Pressurised container	SAR 148.85	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
SERETIDE EVOHALER	125,25 µg,µg	Pressurised inhalation, suspension · Inhalation use	1 Pressurised container	SAR 112.80	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
SERETIDE EVOHALER 25/50	50,25 µg,µg	Pressurised inhalation, suspension · Inhalation use	1 Pressurised container	SAR 79.90	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
Seroflo 25/125 inhaler	125,25 µg,µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 69.70	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Seroflo 25/250 inhaler	250,25 µg,µg	Inhalation powder · Inhalation use	1 Inhaler	SAR 91.95	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Seroflo 50/100 Ciphaler	100,50 µg,µg	Inhalation powder · Inhalation use	60 Blister	SAR 59.55	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Seroflo 50/250 Ciphaler	250,50 µg,µg	Inhalation powder · Inhalation use	60 Blister	SAR 79.65	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Seroflo 50/500 ciphaler	500,50 µg,µg	Inhalation powder · Inhalation use	60 Blister	SAR 110.90	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
RESPIRA Aurohaler 25/125	25, 125 µg	Pressurised inhalation, suspension · Inhalation use	1 Pressurised container	SAR 107.85	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
RESPIRA Aurohaler 25/250	25, 250 µg	Pressurised inhalation, suspension · Inhalation use	1 Pressurised container	SAR 142.30	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
RESPIRA Aurohaler 25/50	25, 50 µg	Pressurised inhalation, suspension · Inhalation use	1 Pressurised container	SAR 76.35	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
RESPIRA Diskair 50/100	50, 100 µg	Inhalation powder, pre-dispensed · Inhalation use	1 Inhaler	SAR 77.20	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
RESPIRA Diskair 50/250	50, 250 µg	Inhalation powder, pre-dispensed · Inhalation use	1 Inhaler	SAR 108.75	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
RESPIRA Diskair 50/500	50, 500 µg	Inhalation powder, pre-dispensed · Inhalation use	1 Inhaler	SAR 143.45	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed

3 more — full table

Indications — CHI Daman Drug Formulary

ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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

Product	Strength	Form · route	Applicant	Status	First approved
ADVAIR DISKUS 100/50	0.1MG/INH;EQ 0.05MG BASE/INH	powder · inhalation	GLAXO GRP LTD	Prescription	24 Aug 2000
ADVAIR DISKUS 250/50	0.25MG/INH;EQ 0.05MG BASE/INH	powder · inhalation	GLAXO GRP LTD	Prescription	24 Aug 2000
ADVAIR DISKUS 500/50	0.5MG/INH;EQ 0.05MG BASE/INH	powder · inhalation	GLAXO GRP LTD	Prescription	24 Aug 2000
ADVAIR HFA	0.045MG/INH;EQ 0.021MG BASE/INH; 0.115MG/INH;EQ 0.021MG BASE/INH; 0.23MG/INH;EQ 0.021MG BASE/INH	aerosol, metered · inhalation	GLAXO GRP LTD	Prescription	8 Jun 2006
AIRDUO RESPICLICK	0.055MG/INH;EQ 0.014MG BASE/INH; 0.113MG/INH;EQ 0.014MG BASE/INH; 0.232MG/INH;EQ 0.014MG BASE/INH	powder · inhalation	TEVA PHARM	Prescription	27 Jan 2017
WIXELA INHUB	0.1MG/INH;EQ 0.05MG BASE/INH; 0.25MG/INH;EQ 0.05MG BASE/INH; 0.5MG/INH;EQ 0.05MG BASE/INH	powder · inhalation	MYLAN	Prescription	30 Jan 2019
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH; 0.25MG/INH;EQ 0.05MG BASE/INH; 0.5MG/INH;EQ 0.05MG BASE/INH	powder · inhalation	HIKMA PHARMS	Prescription	17 Dec 2020
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH; 0.25MG/INH;EQ 0.05MG BASE/INH; 0.5MG/INH;EQ 0.05MG BASE/INH	powder · inhalation	TEVA PHARMS USA	Prescription	13 Dec 2021
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH; 0.25MG/INH;EQ 0.05MG BASE/INH	powder · inhalation	RESPIRENT PHARMS	Prescription	12 Jan 2026
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH; 0.25MG/INH;EQ 0.05MG BASE/INH; 0.5MG/INH;EQ 0.05MG BASE/INH	powder · inhalation	CIPLA	Prescription	27 Jul 2026
AIRDUO DIGIHALER	0.055MG/INH;EQ 0.014MG BASE/INH; 0.113MG/INH;EQ 0.014MG BASE/INH; 0.232MG/INH;EQ 0.014MG BASE/INH	powder · inhalation	TEVA PHARM	Discontinued	27 Jan 2017

EMA European Union — centrally authorised medicines

Seffalair Spiromax Teva B.V. · Authorised · authorised 26 Mar 2021 · ATC R03AK06

Therapeutic indication (EMA)

Seffalair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ?? agonists.

Aerivio Spiromax Teva B.V. · Withdrawn · authorised 18 Aug 2016 · ATC R03AK06

Therapeutic indication (EMA)

Aerivio Spiromax is indicated for use in adults aged 18 years and older only. Asthma Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 agonist) is appropriate: patients not adequately controlled on a lower strength corticosteroid combination product or patients already controlled on a high dose inhaled corticosteroid and long-acting ?2 agonist. Chronic Obstructive Pulmonary Disease (COPD) Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Airexar Spiromax Teva B.V. · Withdrawn · authorised 18 Aug 2016 · ATC R03AK06

Therapeutic indication (EMA)

Airexar Spiromax is indicated for use in adults aged 18 years and older only. AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 agonist) is appropriate: - patients not adequately controlled on a lower strength corticosteroid combination product or - patients already controlled on a high dose inhaled corticosteroid and long-acting ?2 agonist. Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

BroPair Spiromax Teva B.V. · Withdrawn · authorised 26 Mar 2021 · ATC R03AK06

Therapeutic indication (EMA)

BroPair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ?? agonists.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADVAIR	02245126	25 MCG / ACT; 125 MCG / ACT	AEROSOL (METERED-DOSE) · INHALATION	GLAXOSMITHKLINE INC
ADVAIR	02245127	250 MCG / ACT; 25 MCG / ACT	AEROSOL (METERED-DOSE) · INHALATION	GLAXOSMITHKLINE INC
ADVAIR 100 DISKUS	02240835	50 MCG / ACT; 100 MCG / ACT	POWDER · INHALATION	GLAXOSMITHKLINE INC
ADVAIR 250 DISKUS	02240836	250 MCG / ACT; 50 MCG / ACT	POWDER · INHALATION	GLAXOSMITHKLINE INC
ADVAIR 500 DISKUS	02240837	500 MCG / ACT; 50 MCG / ACT	POWDER · INHALATION	GLAXOSMITHKLINE INC
PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI	02494507	50 MCG / ACT; 100 MCG / ACT	POWDER · INHALATION	PHARMASCIENCE INC
PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI	02494515	50 MCG / ACT; 250 MCG / ACT	POWDER · INHALATION	PHARMASCIENCE INC
PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI	02494523	50 MCG / ACT; 500 MCG / ACT	POWDER · INHALATION	PHARMASCIENCE INC
WIXELA INHUB	02495597	100 MCG / ACT; 50 MCG / ACT	POWDER · INHALATION	MYLAN PHARMACEUTICALS ULC
WIXELA INHUB	02495600	50 MCG / ACT; 250 MCG / ACT	POWDER · INHALATION	MYLAN PHARMACEUTICALS ULC
WIXELA INHUB	02495619	50 MCG / ACT; 500 MCG / ACT	POWDER · INHALATION	MYLAN PHARMACEUTICALS ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ADVAIR 100-50 DISKUS	$2.48669	per EA	23 Sep 2026
US NADAC	ADVAIR 250-50 DISKUS	$3.12275	per EA	23 Sep 2026
US NADAC	ADVAIR 500-50 DISKUS	$4.2281	per EA	23 Sep 2026
US NADAC	ADVAIR HFA 115-21 MCG INHALER	$25.39279	per GM	23 Sep 2026
US NADAC	ADVAIR HFA 115-21 MCG INHALER	$18.73125	per GM	23 Sep 2026
US NADAC	ADVAIR HFA 230-21 MCG INHALER	$35.01808	per GM	23 Sep 2026
US NADAC	ADVAIR HFA 230-21 MCG INHALER	$30.53125	per GM	23 Sep 2026
US NADAC	ADVAIR HFA 45-21 MCG INHALER	$19.9752	per GM	23 Sep 2026
US NADAC	ADVAIR HFA 45-21 MCG INHALER	$20.01825	per GM	23 Sep 2026
US NADAC	FLUTICASONE-SALMETEROL 100-50	$1.07358	per EA	7 Oct 2026
US NADAC	FLUTICASONE-SALMETEROL 113-14	$108.27886	per EA	23 Sep 2026
US NADAC	FLUTICASONE-SALMETEROL 115-21	$20.70767	per GM	23 Sep 2026
NHS Drug Tariff	Fluticasone 125micrograms/dose / Salmeterol 25micrograms/dose inhaler CFC free	£23.45	120 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone 250micrograms/dose / Salmeterol 25micrograms/dose inhaler CFC free	£29.32	120 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone 50micrograms/dose / Salmeterol 25micrograms/dose inhaler CFC free	£17.46	120 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone propionate 100micrograms/dose / Salmeterol 50micrograms/dose dry powder inhaler	£17.46	60 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone propionate 250micrograms/dose / Salmeterol 50micrograms/dose dry powder inhaler	£33.95	60 dose	1 Oct 2026
NHS Drug Tariff	Fluticasone propionate 500micrograms/dose / Salmeterol 50micrograms/dose dry powder inhaler	£32.74	60 dose	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.

Components

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.