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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||DuoResp Spiromax|
|Auth. number :||EU/1/14/920|
|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:||DuoResp Spiromax is indicated in adults 18 years of age and older only. |
DuoResp 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|
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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|01/05/2014||Centralised - Authorisation||EMEA/H/C/2348||(2014)2931 of 28/04/2014|
|21/07/2014||Centralised - Variation||EMEA/H/C/2348/IA/1|
|Updated with Decision(2015)4855 of 08/07/2015|
|11/09/2014||Corrigendum||(2014)2931 of 28/04/2014|
|13/07/2015||Centralised - Yearly update||(2015)4855 of 08/07/2015|
|17/09/2015||Centralised - Variation||EMEA/H/C/2348/IB/11/G|
|Updated with Decision(2016)4299 of 04/07/2016|
|06/07/2016||Referral||EMEA/H/A-31/1415||(2016)4299 of 04/07/2016|
|24/03/2017||Centralised - Variation||EMEA/H/C/2348/IB/20/G|
|09/06/2017||Centralised - Variation||EMEA/H/C/2348/IAIN/21|