436 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: 39, Authorised, Last updated: 16/10/2020bosentan … 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: 13, Authorised, Last updated: 15/10/2020bosentan monohydrate … International non-proprietary name: bosentan Procedure No. EMEA/H/C/PSUSA/00000425/201411 … Assessment Report on the PSUR for bosentan, the scientific conclusions … -
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Orphan designation: Bosentan for: Treatment of systemic sclerosis (scleroderma)
Date of first decision: 18/03/2003, Withdrawn, Last updated: 08/05/2014Limited, United Kingdom, for bosentan for the treatment of systemic … treatment of systemic sclerosis. Bosentan for treatment of systemic … orphan drug designation. Bosentan might be of potential significant … -
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Orphan designation: Bosentan for: Treatment of idiopathic pulmonary fibrosis
Date of first decision: 05/09/2008, Withdrawn, Last updated: 08/05/2014Limited, United Kingdom, for bosentan for the treatment of idiopathic … orphan drug designation. Bosentan might be of potential significant … medicine expected to work? Bosentan opposes the effect of a substance … -
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Orphan designation: Bosentan for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of first decision: 15/02/2001, Expired, Last updated: 27/02/2013Pharmaceuticals, France, for bosentan for the treatment of pulmonary … United Kingdom in July 2001. Bosentan for treatment of pulmonary … orphan-drug designation. Bosentan might be of potential significant … -
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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 … application for Rotigotine Mylan (rotigotine) On 22 December … On 22 December 2017, Mylan SAS officially notified the … -
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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: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015Aripiprazole Mylan: Withdrawn application … application for Aripiprazole Mylan (aripiprazole) On 7 May … authorisation for Aripiprazole Mylan, for the treatment of schizophrenia … -
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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 … application for Docetaxel Mylan (docetaxel) On 8 March … docetaxel) On 8 March 2010, 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 … Alendronic Acid/Colecalciferol Mylan (alendronic acid and colecalciferol … colecalciferol) On 27 May 2016, Mylan SAS officially notified the … -
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,
, Revision: 8, Authorised, Last updated: 16/02/2021
Darunavir Mylan HIV Infections … report (EPAR) for Darunavir Mylan. It explains how the Agency … advice on how to use Darunavir Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 8, Authorised, Last updated: 08/12/2020
Ritonavir Mylan HIV Infections … Ritonavir Mylan … for the public Ritonavir Mylan ritonavir This is a summary … -
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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: 2, Authorised, Last updated: 28/01/2021
Deferasirox Mylan Iron Overload beta-Thalasse … 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): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 5, Authorised, Last updated: 14/01/2021
Zonisamide Mylan Epilepsy … Zonisamide Mylan … Zonisamide Mylan, INN-zonisamide 30 … -
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Human medicine European public assessment report (EPAR): Duloxetine Mylan
duloxetine, Neuralgia, Diabetic Neuropathies, Anxiety Disorders, Depressive Disorder, Major
Date of authorisation: 19/06/2015,, Revision: 13, Authorised, Last updated: 18/11/2020
Duloxetine Mylan Neuralgia Diabetic Neuropathies Anxiety … Duloxetine Mylan … for the public Duloxetine Mylan duloxetine This is a summary … -
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Human medicine European public assessment report (EPAR): Fulvestrant Mylan
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 4, Authorised, Last updated: 15/10/2020
Fulvestrant Mylan Breast Neoplasms … Fulvestrant Mylan … Fulvestrant Mylan; INN-fulvestrant 30 … -
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 1, Authorised, Last updated: 16/09/2020
Azacitidine Mylan Myelodysplastic Syndromes Leukemia … Azacitidine Mylan … Azacitidine Mylan azacitidine azacitidine … -
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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: 4, Authorised, Last updated: 18/05/2020
Febuxostat Mylan Hyperuricemia Arthritis … Febuxostat Mylan … Febuxostat Mylan, INN - febuxostat … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 24/06/2015,, Revision: 8, Authorised, Last updated: 16/04/2020
Pregabalin Mylan Anxiety Disorders Epilepsy … Pregabalin Mylan … Pregabalin Mylan,INN-pregabalin 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 1, Authorised, Last updated: 20/03/2020
Ambrisentan Mylan Hypertension, Pulmonary … Ambrisentan Mylan … Ambrisentan Mylan ambrisentan ambrisentan … -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 11, Authorised, Last updated: 17/01/2020
Tadalafil Mylan Erectile Dysfunction … Tadalafil Mylan … Tadalafil Mylan, INN-tadalafil 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: 15, Authorised, Last updated: 09/10/2019
Olanzapine Mylan Schizophrenia Bipolar Disor … Olanzapine Mylan … REPORT (EPAR) OLANZAPINE MYLAN EPAR summary for the public … -
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Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 1, Authorised, Last updated: 21/06/2019
Gefitinib Mylan Carcinoma, Non-Small-Cell … Gefitinib Mylan … authorisation) Gefitinib Mylan gefitinib On 26 July 2018 …