Budesonide/Formoterol Teva
Withdrawn
This medicine's authorisation has been withdrawn
budesonide / formoterol
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Budesonide/Formoterol Teva has been withdrawn at the request of the marketing-authorisation holder.
Budesonide/Formoterol Teva : EPAR - Summary for the public
Reference Number: EMA/601019/2014
English (EN) (218.08 KB - PDF)
First published: Last updated:
български (BG) (283.13 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
español (ES) (218.08 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
čeština (CS) (286.09 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
dansk (DA) (218.16 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Deutsch (DE) (221.56 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
eesti keel (ET) (227.26 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
ελληνικά (EL) (288.69 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
français (FR) (241.63 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
hrvatski (HR) (239.52 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
italiano (IT) (216.72 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
latviešu valoda (LV) (261.49 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
lietuvių kalba (LT) (267.39 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
magyar (HU) (260.81 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Malti (MT) (266.82 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Nederlands (NL) (218.13 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
polski (PL) (263.5 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
português (PT) (240.68 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
română (RO) (245.53 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
slovenčina (SK) (286.28 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
slovenščina (SL) (275.44 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Suomi (FI) (215.95 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
svenska (SV) (217.83 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Budesonide/Formoterol Teva : EPAR - Risk-management-plan summary
Reference Number: EMA/639304/2014
English (EN) (411.39 KB - PDF)
First published: Last updated:
Product information
Budesonide/Formoterol Teva : EPAR - Product Information
English (EN) (826.65 KB - PDF)
First published: Last updated:
български (BG) (1.57 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
español (ES) (868.13 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
čeština (CS) (1.17 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
dansk (DA) (800.12 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Deutsch (DE) (872.95 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
eesti keel (ET) (787.63 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
ελληνικά (EL) (1.63 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
français (FR) (901.88 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
hrvatski (HR) (873.05 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
íslenska (IS) (824.4 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
italiano (IT) (785.48 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
latviešu valoda (LV) (1.17 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
lietuvių kalba (LT) (842.71 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
magyar (HU) (1.19 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Malti (MT) (1.18 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Nederlands (NL) (838.23 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
norsk (NO) (829.08 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
polski (PL) (1.22 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
português (PT) (852.55 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
română (RO) (857.73 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
slovenčina (SK) (1.16 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
slovenščina (SL) (1.15 MB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Suomi (FI) (817.15 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
svenska (SV) (818.27 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
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).
Budesonide/Formoterol Teva : EPAR - All Authorised presentations
English (EN) (148.9 KB - PDF)
First published: Last updated:
български (BG) (177.38 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
español (ES) (154.67 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
čeština (CS) (167.8 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
dansk (DA) (148.6 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Deutsch (DE) (150.75 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
eesti keel (ET) (148.63 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
ελληνικά (EL) (178.23 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
français (FR) (149.01 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
hrvatski (HR) (156.27 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
íslenska (IS) (149.36 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
italiano (IT) (149.61 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
latviešu valoda (LV) (176.69 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
lietuvių kalba (LT) (163.9 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
magyar (HU) (158.21 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Malti (MT) (171.76 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Nederlands (NL) (148.84 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
norsk (NO) (146.07 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
polski (PL) (162.91 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
português (PT) (147.19 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
română (RO) (164.81 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
slovenčina (SK) (169.72 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
slovenščina (SL) (160.28 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
Suomi (FI) (149.3 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
svenska (SV) (151.69 KB - PDF)
First published: 04/12/2014Last updated: 31/01/2017
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.
Authorisation details
- EMA product number
- EMEA/H/C/003951
- Marketing authorisation holder
- Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands - Marketing authorisation issued
- 19/11/2014
- Revision
- 2
Assessment history
Budesonide/Formoterol Teva : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (222.74 KB - PDF)
First published: Last updated:
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion
English (EN) (184.47 KB - PDF)
First published: Last updated:
български (BG) (258.44 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
español (ES) (185.55 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
čeština (CS) (240.13 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
dansk (DA) (183.32 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
Deutsch (DE) (188.6 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
eesti keel (ET) (190.99 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
ελληνικά (EL) (267.25 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
français (FR) (185.95 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
hrvatski (HR) (215.19 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
italiano (IT) (182.71 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
latviešu valoda (LV) (239.48 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
lietuvių kalba (LT) (217.79 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
magyar (HU) (227.4 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
Malti (MT) (244.94 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
Nederlands (NL) (184.25 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
polski (PL) (221.03 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
português (PT) (184.53 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
română (RO) (218.31 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
slovenčina (SK) (239.17 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
slovenščina (SL) (233.71 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
Suomi (FI) (182.58 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
svenska (SV) (184.6 KB - PDF)
First published: 15/07/2016Last updated: 31/01/2017
Budesonide/Formoterol Teva-H-C-3951-A31-14165: EPAR - Assessment Report - Article 31
AdoptedReference Number: EMA/330021/2016
English (EN) (228.27 KB - PDF)
First published: Last updated:
Budesonide/Formoterol Teva : EPAR - Public assessment report
AdoptedReference Number: EMA/CHMP/707207/2014
English (EN) (1.92 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Budesonide / Formoterol Teva
AdoptedReference Number: EMA/CHMP/436479/2014
English (EN) (215.7 KB - PDF)
First published: Last updated:
News on Budesonide/Formoterol Teva
More information on Budesonide/Formoterol Teva
Public statement on Budesonide/Formoterol Teva: Withdrawal of the marketing authorisation in the European Union
English (EN) (58.4 KB - PDF)
First published: Last updated:
Topics
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