531 results
-
List item
Withdrawn application: Raltegravir Viatris
raltegravir potassium, date of withdrawal: 22/02/2023, Initial authorisation, Last updated: 21/04/2023Raltegravir Viatris: Withdrawn application … Raltegravir Viatris: Withdrawal of the marketing … authorisation of Raltegravir Viatris (raltegravir) The company Viatris withdrew its application … -
List item
Human medicine European public assessment report (EPAR): Pirfenidone Viatris
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,
, Authorised, Last updated: 17/01/2023
Pirfenidone Viatris Pulmonary Fibrosis Lung … Pirfenidone Viatris … EMEA/H/C/005862 Pirfenidone Viatris (pirfenidone) An overview … -
List item
Human medicine European public assessment report (EPAR): Dapagliflozin Viatris
dapagliflozin, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 24/03/2023,, Authorised, Last updated: 04/04/2023
Dapagliflozin Viatris Diabetes Mellitus Glucose … dapagliflozin Overview Dapagliflozin Viatris is a medicine used to treat … 2 diabetes, Dapagliflozin Viatris is used in adults and children … -
List item
Human medicine European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 4, Authorised, Last updated: 23/06/2023
Rivaroxaban Viatris (previously Rivaroxaban Mylan) Cardiovascular … Rivaroxaban Viatris : EPAR - All authorised presentations … MEDICINAL PRODUCT Rivaroxaban Viatris 2.5 mg film-coated tablets … -
List item
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Date of authorisation: 19/11/2014, Revision: 2, Withdrawn, Last updated: 31/01/2017Budesonide/Formoterol Teva Pulmonary Disease … Budesonide/Formoterol Teva … Public statement BudesonideFormoterolTeva3951.doc 30 Churchill Place … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
Clopidogrel Viatris (previously Clopidogrel Taw … Clopidogrel Viatris (previously Clopidogrel Taw … EMEA/H/C/001189 Clopidogrel Viatris1 (clopidogrel) An overview … -
List item
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: 08/12/2021Budesonide/Formoterol Teva Pharma B.V. Lung Diseases … Budesonide/Formoterol Teva Pharma B.V … THE MEDICINAL PRODUCT Budesonide/Formoterol Teva Pharma B.V. 160 micrograms … -
List item
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: 30/01/2017Budesonide/Formoterol Teva Pharma B.V. Asthma … Budesonide/Formoterol Teva Pharma B.V … EMEA/H/C/003953 Public statement Budesonide/Formoterol Teva Pharma B.V. Withdrawal … -
List item
Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,
, 
, 
, Revision: 5, Authorised, Last updated: 21/08/2023
Authorised budesonide Overview Kinpeygo is a medicine … active substance in Kinpeygo, budesonide, is a corticosteroid. Corticosteroids … Kinpeygo is designed to release budesonide when it reaches the intestine … -
List item
Orphan designation: Budesonide for: Treatment of primary IgA nephropathy
Date of designation: 18/11/2016, Positive, Last updated: 14/09/2022Budesonide … opinion on orphan designation Budesonide for the treatment of primary … Pharmalink AB, Sweden, for budesonide for the treatment of primary … -
List item
Human medicine European public assessment report (EPAR): Jorveza
Budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,
, , Revision: 6, Authorised, Last updated: 06/12/2022
budesonide … Assessment Report Jorveza (budesonide) 30 Churchill Place … Assessment Report Jorveza (budesonide) Treatment of eosinophilic … -
List item
Orphan designation: Budesonide for: Treatment of eosinophilic oesophagitis
Date of designation: 05/08/2013, Positive, Last updated: 18/01/2018Budesonide … opinion on orphan designation Budesonide for the treatment of eosinophilic … opinion on orphan designation Budesonide for the treatment of eosinophilic … -
List item
Human medicine European public assessment report (EPAR): Labazenit
Budesonide, salmeterol, Asthma
Date of refusal: 06/09/2013, Refused, Last updated: 22/03/2013budesonide / salmeterol … authorisation for Labazenit (budesonide / salmeterol) Outcome of … contains the active substances budesonide and salmeterol. It was to … -
List item
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: 12, Authorised, Last updated: 15/05/2023Authorised budesonideformoterol Overview BiResp Spiromax … medicine. active substances budesonide and formoterol. It is used … beta-2 agonists’ (such as budesonide and formoterol) taken by … -
List item
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: 12, Authorised, Last updated: 11/05/2023Authorised budesonideformoterol Overview DuoResp Spiromax … medicine. active substances budesonide and formoterol. It is used … beta-2 agonists’ (such as budesonide and formoterol) taken by … -
List item
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: 26/01/2017budesonide / formoterol … authorisation for Vylaer Spiromax (budesonide / formoterol) in the European … public Vylaer Spiromax budesonide / formoterol This is a … -
List item
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: 20/05/2022glycopyrronium bromide / budesonide … glycopyrronium bromide / budesonide) An overview of Trixeo Aerosphere … glycopyrronium bromide and budesonide. How is Trixeo Aerosphere … -
List item
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: 20/05/2022glycopyrronium bromide and budesonide. This medicine is the same … to keep the airways open. Budesonide belongs to a group of anti-inflammatory … different inhalers containing budesonide/formoterol. The second study, which lasted … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Trixeo Aerosphere, Budesonide, Formoterol (fumarate), Glycopyrronium bromide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002063-PIP01-16-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, suspension
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: XAerosphere Active substance Budesonide Formoterol (fumarate) Glycopyrronium … paediatric investigation plan for budesonide / glycopyrronium bromide … paediatric investigation plan for budesonide / glycopyrronium bromide … -
List item
Referral: Budesonide SUN
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/06/2020, EC decision date: 19/08/2020, Last updated: 16/09/2020Budesonide SUN … Budesonide SUN … budesonide … -
List item
Referral: Budesonide Sandoz
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/02/2009, EC decision date: 07/05/2009, Last updated: 25/06/2009Budesonide Sandoz … authorisation of the medicine Budesonide Sandoz. The Agency's Committee … concluded that the benefits of Budesonide Sandoz outweigh its risks … -
List item
Orphan designation: Budesonide for: Treatment of graft-versus-host disease
Date of designation: 03/11/2006, Positive, Last updated: 21/06/2011Budesonide … smop budesonide 7 Westferry Circus … opinion on orphan designation Budesonide (oral use) for the treatment … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Budesonide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001087-PIP02-12-M03, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Nebuliser suspension
Decision date: 31/01/2017, Last updated: 20/03/2017, Compliance check: XActive substance Budesonide Therapeutic area Pneumology-allergology … paediatric investigation plan for budesonide (EMEA-001087-PIP02-12-M03) 30 … paediatric investigation plan for budesonide (EMEA- 001087-PIP02-12-M03 … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Budesonide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001120-PIP01-10, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, solution
Decision date: 30/11/2011, Last updated: 21/12/2011, Compliance check: Xassociated names Active substance Budesonide Therapeutic area Neonatology-Paediatric … granting of a waiver for budesonide (Budiair and associated … granting of a waiver for budesonide (Budiair and associated … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Budesonide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-002500-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified release capsule
Decision date: 29/01/2020, Last updated: 10/06/2020, Compliance check: XActive substance Budesonide Therapeutic area Uro-nephrology … Budesonide …