485 results
Keyword Budesonide Sandoz Remove keyword
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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 … Budesonide Sandoz … Budesonide Sandoz referrals European … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … application for Duloxetine Sandoz (duloxetine) On 08 April … duloxetine) On 08 April 2015, Sandoz GmbH officially notified … -
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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Date of authorisation: 19/11/2014, Revision: 2, Withdrawn, Last updated: 31/01/2017Budesonide/Formoterol Teva Pulmonary Disease … Budesonide/Formoterol Teva … Public statement BudesonideFormoterolTeva3951.doc 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 11/11/2013, Revision: 8, Authorised, Last updated: 14/12/2020Levodopa/Carbidopa/Entacapone Sandoz) Parkinson Disease … Levodopa/Carbidopa/Entacapone Sandoz) … Levodopa/Carbidopa/Entacapone Sandoz) levodopa carbidopa entacap … -
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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Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017Budesonide/Formoterol Teva Pharma B.V. Asthma … Budesonide/Formoterol Teva Pharma B.V … EMEA/H/C/003953 Public statement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 … -
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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, Authorised, Last updated: 07/04/2020Budesonide/Formoterol Teva Pharma B.V. Asthma Pulmonary … Budesonide/Formoterol Teva Pharma B.V … Budesonide/Formoterol Teva Pharma B.V budesonide formoterol fumarate dihydrat … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 19/06/2015,
, Revision: 5, Authorised, Last updated: 27/08/2020
Pregabalin Sandoz Anxiety Disorders Neuralgia … Pregabalin Sandoz … for the public Pregabalin Sandoz pregabalin This is a summary … -
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/07/2020
Aripiprazole Sandoz Schizophrenia Bipolar Disor … Aripiprazole Sandoz … Aripiprazole Sandoz EPAR summary 30 … -
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma, Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 16, Authorised, Last updated: 14/10/2019
Temozolomide Sandoz Glioma Glioblastoma … Temozolomide Sandoz … Temozolomide Sandoz, INN-temozolomide EMA/729989/2014 … -
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Human medicine European public assessment report (EPAR): Rivastigmine Sandoz
rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 11, Authorised, Last updated: 04/12/2018Rivastigmine Sandoz Dementia Alzheimer Disease Parkinson … Rivastigmine Sandoz … Rivastigmine Sandoz, INN-rivastigmine … -
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Human medicine European public assessment report (EPAR): Clopidogrel Sandoz
clopidogrel, Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 2, Withdrawn, Last updated: 26/10/2011
Clopidogrel Sandoz Peripheral Vascular Diseases Stroke Myocardial … Clopidogrel Sandoz … Clopidogrel Sandoz (clopidogrel) Withdrawal … -
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Orphan designation: budesonide for: Treatment of eosinophilic oesophagitis
Date of first decision: 05/08/2013, Positive, Last updated: 18/01/2018Pharma GmbH, Germany, for budesonide for the treatment of eosinophilic … eosinophilic oesophagitis. Budesonide has been authorised in the … medicine expected to work? Budesonide is a well-known corticosteroid … -
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Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,
, 
, Revision: 2, Authorised, Last updated: 04/06/2020
budesonide … Assessment Report Jorveza (budesonide) 30 Churchill Place … Assessment Report Jorveza (budesonide) Treatment of eosinophilic … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 19/06/2015,, Revision: 7, Authorised, Last updated: 10/02/2021
Pregabalin Sandoz GmbH Anxiety Disorders Epil … report (EPAR) for Pregabalin Sandoz GmbH. It explains how the … on how to use Pregabalin Sandoz GmbH. For practical information … -
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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 … -
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 8, Authorised, Last updated: 11/11/2020
Ibandronic Acid Sandoz Breast Neoplasms Neoplasm … Ibandronic Acid Sandoz … public Ibandronic Acid Sandoz ibandronic acid This document … -
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Human medicine European public assessment report (EPAR): Pemetrexed Sandoz
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/09/2015,, Revision: 5, Authorised, Last updated: 27/08/2020
Pemetrexed Sandoz Carcinoma, Non-Small-Cell … Pemetrexed Sandoz … for the public Pemetrexed Sandoz pemetrexed This is a summary … -
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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 budesonide … -
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Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 29/06/2016, Last updated: 15/07/2016substances beclomethasone, budesonide, flunisolide, fluticasone … airways). Beclomethasone, budesonide, flunisolide, fluticasone … substances beclomethasone, budesonide, flunisolide, fluticasone … -
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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: 10, Authorised, Last updated: 31/07/2020budesonide / formoterol … public BiResp Spiromax budesonide / formoterol This is a … contains the active substances budesonide and formoterol. It is used … -
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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: 9, Authorised, Last updated: 24/03/2020budesonide / formoterol … DuoResp Spiromax, INN: Budesonide Formoterol fumarate dihydrate … public DuoResp Spiromax budesonide / formoterol This is a … -
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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: 26/01/2017budesonide / formoterol … authorisation for Vylaer Spiromax (budesonide / formoterol) in the European … public Vylaer Spiromax budesonide / formoterol This is a … -
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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, Authorised, Last updated: 05/01/2021glycopyrronium bromide / budesonide … glycopyrronium bromide / budesonide) An overview of Trixeo Aerosphere … glycopyrronium bromide and budesonide. How is Trixeo Aerosphere … -
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Orphan designation: budesonide for: Treatment of primary IgA nephropathy
Date of first decision: 18/11/2016, Positive, Last updated: 13/12/2016Pharmalink AB, Sweden, for budesonide for the treatment of primary … medicine expected to work? Budesonide is a well-known type of medicine … designation, clinical trials with budesonide in patients with primary … -
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Orphan designation: budesonide for: Treatment of graft-versus-host disease
Date of first decision: 03/11/2006, Positive, Last updated: 21/06/2011Pharma GmbH, Germany, for budesonide (oral use) for the treatment … medicine expected to work? Budesonide belongs to the group of corticosteroids … medicinal product contains budesonide, which is intended for use …