SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| BUFOMIX 320/9MCG EASYHALER | 320,9 µg,µg | Inhalation powder · Inhalation use | 1 Inhaler | SAR 84.20 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| SYMBICORT 320 MCG/9 MCG TURBOHALER | 320,9 µg,µg | Inhalation powder · Inhalation use | 1 Inhaler | SAR 129.55 | NCE · Prescription | AstraZeneca | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); GRAFT VERSUS HOST DISEASE
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| SYMBICORT | 0.08MG/INH;0.0045MG/INH; 0.16MG/INH;0.0045MG/INH | aerosol, metered · inhalation | ASTRAZENECA | Prescription | 21 Jul 2006 |
| BREYNA | 0.08MG/INH;0.0045MG/INH; 0.16MG/INH;0.0045MG/INH | aerosol, metered · inhalation | MYLAN | Prescription | 15 Mar 2022 |
| SYMBICORT AEROSPHERE | 0.16MG/INH;0.0048MG/INH; 0.08MG/INH;0.0048MG/INH | aerosol, metered · inhalation | ASTRAZENECA | Prescription | 28 Apr 2023 |
| BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | 0.08MG/INH;0.0045MG/INH; 0.16MG/INH;0.0045MG/INH | aerosol, metered · inhalation | TEVA PHARMS USA INC | Prescription | 23 Apr 2026 |
EMA European Union — centrally authorised medicines
DuoResp Spiromax Teva Pharma B.V. · Authorised · authorised 28 Apr 2014 · ATC R03AK07
Therapeutic indication (EMA)
Asthma DuoResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. COPDDuoResp Spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
BiResp Spiromax Teva Pharma B.V. · Authorised · authorised 28 Apr 2014 · ATC R03AK07
Therapeutic indication (EMA)
Asthma BiResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. COPDBiResp Spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Therapeutic indication (EMA)
Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. Asthma Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. COPD Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Budesonide/Formoterol Teva Teva Pharma B.V. · Withdrawn · authorised 19 Nov 2014 · ATC R03AK07
Therapeutic indication (EMA)
Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only. AsthmaBudesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists.or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists. COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Vylaer Spiromax Teva Pharma B.V. · Withdrawn · authorised 19 Nov 2014 · ATC R03AK07
Therapeutic indication (EMA)
Vylaer Spiromax is indicated in adults 18 years of age and older only. AsthmaVylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists.or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists. COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Therapeutic indication (EMA)
Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate: or in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists. in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists.
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | BREYNA 160-4.5 MCG INHALER | $21.61843 | per GM | 23 Sep 2026 |
| US NADAC | BREYNA 80-4.5 MCG INHALER | $18.53679 | per GM | 23 Sep 2026 |
| US NADAC | BUDESONIDE-FORMOTEROL 160-4.5 | $17.26446 | per GM | 23 Sep 2026 |
| US NADAC | BUDESONIDE-FORMOTEROL 80-4.5 | $15.66845 | per GM | 23 Sep 2026 |
| US NADAC | SYMBICORT 160-4.5 MCG INHALER | $21.98404 | per GM | 23 Sep 2026 |
| US NADAC | SYMBICORT 160-4.5 MCG INHALER | $25.45735 | per GM | 23 Sep 2026 |
| US NADAC | SYMBICORT 80-4.5 MCG INHALER | $19.24533 | per GM | 23 Sep 2026 |
| US NADAC | SYMBICORT 80-4.5 MCG INHALER | $19.28281 | per GM | 23 Sep 2026 |
| NHS Drug Tariff | Budesonide 100micrograms/dose / Formoterol 3micrograms/dose inhaler CFC free | £14.00 | 120 dose | 1 Oct 2026 |
| NHS Drug Tariff | Budesonide 100micrograms/dose / Formoterol 6micrograms/dose dry powder inhaler | £28.00 | 120 dose | 1 Oct 2026 |
| NHS Drug Tariff | Budesonide 200micrograms/dose / Formoterol 6micrograms/dose dry powder inhaler | £28.00 | 120 dose | 1 Oct 2026 |
| NHS Drug Tariff | Budesonide 200micrograms/dose / Formoterol 6micrograms/dose inhaler CFC free | £28.00 | 120 dose | 1 Oct 2026 |
| NHS Drug Tariff | Budesonide 400micrograms/dose / Formoterol 12micrograms/dose dry powder inhaler | £28.00 | 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.
WHO WHO Model List of Essential Medicines (2025)
- 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
Asthma
Respiratory > Inhalation > powder: 100 µg + 6 µg per dose actuation in dry powder inhaler; 200 µg + 6 µg per dose actuation in dry powder inhaler
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.