578 results
Keyword Bosentan Mylan Remove keyword
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Human medicine European public assessment report (EPAR): Tracleer
bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 41, Authorised, Last updated: 29/10/2021bosentan … Tracleer, INN-bosentan 30 Churchill Place … authorisation(s) Active substance(s): bosentan Procedure No. EMEA/H/C/PSUSA/00000425/201511 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tracleer, Bosentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000425-PIP02-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 29/04/2013, Last updated: 31/05/2013, Compliance check: V, 21/03/2014Tracleer Active substance Bosentan Therapeutic area Pneumology-allergology … paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04 … paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04 … -
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Human medicine European public assessment report (EPAR): Stayveer
bosentan (as monohydrate), Hypertension, Pulmonary; Scleroderma, Systemic
Date of authorisation: 24/06/2013, Revision: 14, Authorised, Last updated: 20/07/2021Authorised bosentan monohydrate Overview Stayveer … medicine. active substance bosentan. This medicine is the same … active substance in Stayveer, bosentan, blocks a naturally occurring … -
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Orphan designation: Bosentan for: Treatment of systemic sclerosis (scleroderma)
Date of designation: 18/03/2003, Withdrawn, Last updated: 08/05/2014Bosentan Overview Please note that … Limited, United Kingdom, for bosentan for the treatment of systemic … treatment of systemic sclerosis. Bosentan for treatment of systemic … -
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Orphan designation: Bosentan for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 05/09/2008, Withdrawn, Last updated: 08/05/2014Bosentan Overview Please note that … Limited, United Kingdom, for bosentan for the treatment of idiopathic … orphan drug designation. Bosentan might be of potential significant … -
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Orphan designation: Bosentan for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 15/02/2001, Expired, Last updated: 27/02/2013Bosentan Overview Please note that … Pharmaceuticals, France, for bosentan for the treatment of pulmonary … United Kingdom in July 2001. Bosentan for treatment of pulmonary … -
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Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
clopidogrel hydrochloride, Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 21/09/2009,
, Revision: 19, Authorised, Last updated: 22/02/2022
Pharma (previously Clopidogrel Mylan) Vascular Diseases Cardiovascular … Clopidogrel Taw Pharma Clopidogrel Mylan received a The approval to … Pharma (previously Clopidogrel Mylan) : EPAR - Summary for the … -
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Withdrawn application: Fingolimod Mylan
fingolimod, date of withdrawal: 08/05/2020, Initial authorisation, Last updated: 17/06/2020Fingolimod Mylan: Withdrawn application … Fingolimod Mylan Fingolimod Mylan fingolimod fingolimod hydro … -
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Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018Rotigotine Mylan: Withdrawn application … Rotigotine Mylan: Withdrawal of the marketing … application for Rotigotine Mylan (rotigotine) On 22 December … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015Aripiprazole Mylan: Withdrawn application … Aripiprazole Mylan: Withdrawal of the marketing … application for Aripiprazole Mylan (aripiprazole) On 7 May … -
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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … Docetaxel Mylan: Withdrawal of the marketing … application for Docetaxel Mylan (docetaxel) On 8 March … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 08/01/2016, Initial authorisation, Last updated: 29/03/2016Aripiprazole Mylan: Withdrawn application … application for Aripiprazole Mylan (aripiprazole) On 8 January … aripiprazole) On 8 January 2016, Mylan S.A.S. officially notified … -
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Withdrawn application: Alendronic Acid / Colecalciferol Mylan
date of withdrawal: 27/05/2016, Initial authorisation, Last updated: 02/02/2017dronic Acid / Colecalciferol Mylan: Withdrawn application … dronic Acid / Colecalciferol Mylan: Withdrawal of the marketing … Alendronic Acid/Colecalciferol Mylan (alendronic acid and colecalciferol … -
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 12, Authorised, Last updated: 06/05/2022
Ritonavir Mylan Blood-Borne Infections Communicable … report (EPAR) for Ritonavir Mylan. It explains how the Agency … advice on how to use Ritonavir Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 11, Authorised, Last updated: 18/01/2022
Darunavir Mylan Blood-Borne Infections Communicable … Darunavir Mylan … Darunavir Mylan, INN-darunavir 30 … -
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Human medicine European public assessment report (EPAR): Azacitidine Mylan (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 4, Authorised, Last updated: 24/06/2022
Azacitidine Mylan Bone Marrow Diseases Hematologic … azacitidine Overview Azacitidine Mylan is used for the treatment … myeloid cells). Azacitidine Mylan is used in patients with … -
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Human medicine European public assessment report (EPAR): Gefitinib Mylan (updated)
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 5, Authorised, Last updated: 17/06/2022
Gefitinib Mylan Cancer Neoplasms Respiratory … gefitinib Overview Gefitinib Mylan is a cancer medicine used … receptor (EGFR). Gefitinib Mylan contains the The substance … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 13, Authorised, Last updated: 23/05/2022
Pregabalin Mylan Mental Disorders Nervous … report (EPAR) for Pregabalin Mylan. It explains how the Agency … on how to use Pregabalin Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Lenalidomide Mylan (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Revision: 4, Authorised, Last updated: 31/05/2022
Lenalidomide Mylan Cancer Neoplasms Neoplasms … lenalidomide Overview Lenalidomide Mylan is a medicine used for the … EMEA/H/C/005306 Lenalidomide Mylan (lenalidomide) An overview … -
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Human medicine European public assessment report (EPAR): Deferasirox Mylan
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 7, Authorised, Last updated: 17/05/2022
Deferasirox Mylan Nutritional and Metabolic … deferasirox Overview Deferasirox Mylan is a medicine used to treat … from the gut. Deferasirox Mylan contains the The substance … -
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Human medicine European public assessment report (EPAR): Duloxetine Mylan
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 17, Authorised, Last updated: 25/04/2022
Duloxetine Mylan Nervous System Diseases Neuromuscular … report (EPAR) for Duloxetine Mylan. It explains how the Agency … on how to use Duloxetine Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Febuxostat Mylan
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,, Revision: 7, Authorised, Last updated: 15/03/2022
Febuxostat Mylan Pathological Conditions … Febuxostat Mylan … Febuxostat Mylan, INN - febuxostat … -
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Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 7, Authorised, Last updated: 24/11/2021
Zonisamide Mylan Brain Diseases Central … Zonisamide Mylan … Zonisamide Mylan, INN-zonisamide 30 … -
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Human medicine European public assessment report (EPAR): Olanzapine Mylan
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 17, Authorised, Last updated: 24/11/2021
Olanzapine Mylan Schizophrenia Spectrum and … Olanzapine Mylan … REPORT (EPAR) OLANZAPINE MYLAN EPAR summary for the public … -
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Human medicine European public assessment report (EPAR): 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,, Authorised, Last updated: 25/02/2022
Rivaroxaban Mylan Cardiovascular Diseases Vascular … rivaroxaban Overview Rivaroxaban Mylan is an anticoagulant medicine … with aspirin. Rivaroxaban Mylan contains the The substance …