288 results
Keyword Formoterol Remove keyword
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 19/11/2014, Revision: 2, Withdrawn, Last updated: 31/01/2017Budesonide/Formoterol Teva (budesonide / formoterol) in the European Union (EU … Teva, INN-Budesonide and Formoterol fumarate dihydrate … Budesonide/Formoterol Teva budesonide / formoterol This is a summary of the … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol fumarate dihydrate, Asthma; Pulmonary Disease, Chronic Obstructive
Date of authorisation: 03/04/2020, Revision: 2, Authorised, Last updated: 08/12/2021substances budesonide and formoterol. How is Budesonide/Formoterol … budesonide and 4.5 micrograms of formoterol), which can be used both for … budesonide and 9 micrograms of formoterol) can only be used for the … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017Pharma B.V. (budesonide / formoterol) in the European Union (EU … Pharma B.V. budesonide / formoterol This is a summary of the … substances budesonide and formoterol. It is used for the treatment … -
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Human medicine European public assessment report (EPAR): Duaklir Genuair (updated)
aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,
, Revision: 15, Authorised, Last updated: 11/01/2023
aclidinium bromide and formoterol fumarate dihydrate. How is … aclidinium and 12 micrograms of formoterol fumarate dihydrate for each … Genuair, aclinidium bromide and formoterol fumarate dihydrate, work … -
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Human medicine European public assessment report (EPAR): Bevespi Aerosphere
glycopyrronium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 18/12/2018, Revision: 5, Authorised, Last updated: 13/07/2022glycopyrronium / formoterol fumarate dihydrate … glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate. This … micrograms of glycopyrronium, and formoterol fumarate dihydrate 5.8 micrograms. For … -
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Human medicine European public assessment report (EPAR): DuoResp Spiromax
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 28/04/2014, Revision: 11, Authorised, Last updated: 09/06/2021substances budesonide and formoterol. It is used to treat asthma … agonists’ (such as budesonide and formoterol) taken by inhalation. DuoResp … budesonide and 4.5 micrograms of formoterol) can be used for the regular … -
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Human medicine European public assessment report (EPAR): BiResp Spiromax
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 28/04/2014, Revision: 11, Authorised, Last updated: 09/06/2021substances budesonide and formoterol. It is used to treat asthma … agonists’ (such as budesonide and formoterol) taken by inhalation. BiResp … budesonide and 4.5 micrograms of formoterol) can be used for the regular … -
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Human medicine European public assessment report (EPAR): Vylaer Spiromax
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 19/11/2014, Revision: 3, Withdrawn, Last updated: 26/01/2017Vylaer Spiromax (budesonide / formoterol) in the European Union (EU … Vylaer Spiromax budesonide / formoterol This is a summary of the … substances budesonide and formoterol. It is used for the treatment … -
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Human medicine European public assessment report (EPAR): Brimica Genuair (updated)
formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,, Revision: 13, Authorised, Last updated: 04/01/2023
aclidinium / formoterol fumarate dihydrate … Genuair aclidinium bromide / formoterol fumarate dihydrate This … substances: aclidinium bromide and formoterol fumarate dihydrate. How … -
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Human medicine European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 23/04/2018, Revision: 4, Authorised, Last updated: 13/12/2022substances beclometasone, formoterol and glycopyrronium bromide … patient to breathe more easily. Formoterol is a long-acting beta-2 agonist … Riarify (beclometasone plus formoterol). In the second study lasting … -
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Human medicine European public assessment report (EPAR): Riltrava Aerosphere
budesonide, formoterol fumarate dihydrate, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 06/01/2022, Revision: 1, Authorised, Last updated: 20/05/2022formoterol fumarate dihydrate / glycopyrronium … EMEA/H/C/005311 Riltrava Aerosphere (formoterol / glycopyrronium bromide … contains the active substances formoterol, glycopyrronium bromide and … -
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Human medicine European public assessment report (EPAR): Trixeo Aerosphere
formoterol fumarate dihydrate, glycopyrronium bromide, budesonide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 09/12/2020, Revision: 3, Authorised, Last updated: 20/05/2022formoterol / glycopyrronium bromide … EMEA/H/C/004983 Trixeo Aerosphere (formoterol / glycopyrronium bromide … contains the active substances formoterol, glycopyrronium bromide and … -
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Human medicine European public assessment report (EPAR): Trimbow
Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 17/07/2017, Revision: 7, Authorised, Last updated: 01/04/2022substances beclometasone, formoterol and glycopyrronium bromide … patient to breathe more easily. Formoterol is a long-acting beta-2 agonist … Trimbow (beclometasone / formoterol / glycopyrronium bromide … -
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Human medicine European public assessment report (EPAR): Trydonis
Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 26/04/2018, Revision: 4, Authorised, Last updated: 08/03/2022substances beclometasone, formoterol and glycopyrronium bromide … patient to breathe more easily. Formoterol is a long-acting beta-2 agonist … Trydonis (beclometasone plus formoterol). In the second study lasting … -
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Referral: Flutiform
fluticasone propionate, formoterol fumarate, associated names: Iffeza, Flofera, Flutiformo, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 28/06/2012, Last updated: 25/10/2012fluticasone propionate and formoterol fumarate. They are to be … long-acting beta-2 agonist (such as formoterol fumarate) is appropriate … long-acting beta-2 agonist formoterol fumarate exerts an effect … -
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Referral: Iffeza
fluticasone propionate, formoterol fumarate, associated names: Flutiform, Flofera, Flutiformo, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 28/06/2012, Last updated: 25/10/2012fluticasone propionate and formoterol fumarate. They are to be … long-acting beta-2 agonist (such as formoterol fumarate) is appropriate … long-acting beta-2 agonist formoterol fumarate exerts an effect … -
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Referral: Kantos Master
beclometasone dipropionate, formoterol fumarate, associated names: Kantos, Formodual, Foster, Inuxair, Innovair and associated names, Article 13 referrals
Status: European Commission final decision, opinion/position date: 17/01/2013, EC decision date: 10/04/2013, Last updated: 02/05/2013reduces inflammation), and formoterol fumarate, a bronchodilator … bronchodilator (beclometasone and formoterol) for MART. The CHMP therefore … beclomethasone dipropionate / formoterol fumarate, inhaler) PDF icon … -
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Withdrawn application: Zenhale
date of withdrawal: 05/11/2010, Initial authorisation, Last updated: 20/01/2011Zenhale (mometasone furoate/formoterol fumarate) On 5 November … substances mometasone furoate and formoterol fumarate. It was to be … expected to work? Both formoterol and mometasone have been … -
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Opinion/decision on a Paediatric investigation plan (PIP): fluticasone propionate, formoterol fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000127-PIP01-07-M03, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, suspension
Decision date: 24/11/2014, Last updated: 27/07/2015, Compliance check: V, 13/02/2015facts fluticasone propionate formoterol fumarate Pneumology-allergologyP/0297/2014EMEA-000127-PIP01-07-M03 … fluticasone propionate / formoterol fumarate (Flutiform and associated … fluticasone propionate / formoterol fumarate (Flutiform and associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate, formoterol fumarate dihydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000548-PIP01-09-M08, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Pressurised inhalation, solution
Decision date: 15/06/2018, Last updated: 21/09/2021, Compliance check: V, 26/04/2019Beclometasone dipropionate formoterol fumarate dihydrate Pneumology-allergologyP/0159/2018EMEA-000548-PIP01-09-M08 … Beclometasone dipropionate formoterol fumarate dihydrate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mometasone furoate, formoterol fumarate dihydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000025-PIP01-07-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised metered dose inhaler (MDI) with HFA-227 as propellant, suspension
Decision date: 27/01/2009, Last updated: 06/03/2009, Compliance check: XKey facts Mometasone furoate formoterol fumarate dihydrate Pneumology-allergologyP/4/2009EMEA-000025-PIP01-07-M01 … Plan for mometasone furoate, formoterol fumarate dihydrate (EMEA-000025-PIP01-07 … for mometasone furoate, formoterol fumarate dihydrate (EMEA-000025-PIP01-07-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide (CHF 5993)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001875-PIP02-18-M03, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, solution, Inhalation powder
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: XBeclometasone dipropionate formoterol fumarate dihydrate glycopyrronium … beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium … beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium … -
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Press release: Schering-Plough Europe withdraws its marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate)
Last updated: 09/11/2010Zenhale (mometasone furoate/formoterol fumarate … Zenhale (mometasone furoate/formoterol fumarate) 50/5, 100/5 or … Zenhale (mometasone furoate/formoterol fumarate) PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Onbrez Breezhaler
indacaterol maleate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 29/11/2009, Revision: 17, Authorised, Last updated: 23/09/2021treatment), tiotropium or formoterol (other inhaled medicines … tiotropium, and 80 ml with formoterol. What are the risks associated … treatment), tiotropium or formoterol (other inhaled medicines … -
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Human medicine European public assessment report (EPAR): Oslif Breezhaler
indacaterol maleate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 29/11/2009, Revision: 17, Authorised, Last updated: 08/09/2021treatment), tiotropium or formoterol (other inhaled medicines … tiotropium, and 80 ml with formoterol. What are the risks associated … treatment), tiotropium or formoterol (other inhaled medicines …