- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 16 December 2016, the European Commission withdrew the marketing authorisation for Budesonide/Formoterol Teva Pharma B.V. (budesonide / formoterol) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva Pharma B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Budesonide/Formoterol Teva Pharma B.V. was granted marketing authorisation in the EU on 19 November 2014 for treatment of asthma. The marketing authorisation was initially valid for a 5-year period. Budesonide/Formoterol Teva Pharma B.V. was of DuoResp Spiromax, which is marketed in several EU countries.
The European Public Assessment Report (EPAR) for Budesonide/Formoterol Teva Pharma B.V. is updated accordingly to indicate that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Budesonide/Formoterol Teva Pharma B.V.
- Active substance
- Budesonide
- formoterol
- International non-proprietary name (INN) or common name
- budesonide
- formoterol fumarate dihydrate
- Therapeutic area (MeSH)
- Asthma
- Anatomical therapeutic chemical (ATC) code
- R03AK07
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
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 ?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.