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Community register of medicinal products for human use


Product information

Invented name: BiResp Spiromax   
Auth. number : EU/1/14/921
Active substance : budesonide / formoterol
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R03 - Anti-asthmatics
Pharmacological subgroup: R03A - Adrenergics, inhalants
Chemical subgroup: R03AK - Adrenergics and other anti-asthmatics
Chemical substance: R03AK07 - formoterol and budesonide
(See WHO ATC Index)
Indication: BiResp Spiromax is indicated in adults 18 years of age and older only.


BiResp Spiromax 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.
-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.


Symptomatic 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.
Marketing Authorisation Holder: Teva Pharma B.V.
Swensweg 5, 2031GA Haarlem, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/05/2014 Centralised - Authorisation EMEA/H/C/3890 (2014)2930 of 28/04/2014
17/09/2015 Centralised - Variation EMEA/H/C/3890/IB/9/G
Updated with Decision(2016)4298 of 04/07/2016
4/11/2015 Centralised - Notification EMEA/H/C/3890/N/10
Updated with Decision(2016)4298 of 04/07/2016
6/07/2016 Referral EMEA/H/A-31/415 (2016)4298 of 4/07/2016
24/03/2017 Centralised - Variation EMEA/H/C/3890/IB/19/G
Updated with Decision(2018)1410 of 01/03/2018
9/06/2017 Centralised - Variation EMEA/H/C/3890/IA/20
Updated with Decision(2018)1410 of 01/03/2018
30/11/2017 Centralised - Notification EMEA/H/C/3890/N/22
Updated with Decision(2018)1410 of 01/03/2018
5/03/2018 Centralised - Yearly update (2018)1410 of 1/03/2018