Budesonide/Formoterol Teva
Withdrawn
This medicine's authorisation has been withdrawn
budesonide / formoterol
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 16 December 2016, the European Commission withdrew the marketing authorisation for Budesonide/Formoterol Teva (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 was granted marketing authorisation in the EU on 19 November 2014 for treatment of asthma and chronic obstructive pulmonary disease (COPD). The marketing authorisation was initially valid for a 5-year period. Budesonide/Formoterol Teva was a duplicate of DuoResp Spiromax, which is marketed in several EU countries.
The European Public Assessment Report (EPAR) for Budesonide/Formoterol Teva is updated accordingly to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
A31/0002
16/12/2016
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
- Active substance
- Budesonide
- formoterol fumarate dihydrate
- International non-proprietary name (INN) or common name
- budesonide
- formoterol
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Asthma
- Anatomical therapeutic chemical (ATC) code
- R03AK07
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only.
Asthma
Budesonide/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.
COPD
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.
Assessment history
News on Budesonide/Formoterol Teva
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