10410 results
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,
, Revision: 7, Authorised, Last updated: 09/06/2022
lmanco (previously Tadalafil Generics) Respiratory Tract Diseases Lung … lmanco (previously Tadalafil Generics) … Questions and answers on generic medicines What is a generic medicine? A generic medicine is a medicine that … -
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn application … Pioglitazone Teva Generics: Withdrawal of the marketing … authorisation) Pioglitazone Teva Generics pioglitazone On 22 September … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis; Osteitis Deformans
Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016
Zoledronic acid Teva Generics Osteoporosis Osteitis Defor … for Zoledronic Acid Teva Generics has been withdrawn at the … documents Zoledronic acid Teva Generics : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
Clopidogrel Teva Generics B.V. Peripheral Vascular … authorisation for Clopidogrel Teva Generics B.V. has lapsed because it … documents Clopidogrel Teva Generics B.V. : EPAR - Summary for … -
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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: 20, Authorised, Last updated: 01/07/2022
Pharma (previously Clopidogrel Mylan) Vascular Diseases Cardiovascular … clopidogrel and is a ‘ A generic medicine is a medicine that … company can only market a generic medicine once the 10-year … -
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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 … zole Overview On 7 May 2015, Generics (UK) Limited officially notified … authorisation for Aripiprazole Mylan, for the treatment of schizophrenia … -
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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 … Overview On 22 December 2017, Mylan SAS officially notified the … authorisation for Rotigotine Mylan, for the treatment of Parkinson's … -
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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 … Overview On 8 March 2010, Mylan S.A.S. officially notified … authorisation for Docetaxel Mylan intended to be used to treat … -
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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: 5, Authorised, Last updated: 17/06/2022
Gefitinib Mylan Cancer Neoplasms Respiratory … Gefitinib Mylan is a cancer medicine used … receptor (EGFR). Gefitinib Mylan contains the active substance … -
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Human medicine European public assessment report (EPAR): Olanzapine Mylan
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 18, Authorised, Last updated: 17/01/2023
Olanzapine Mylan Schizophrenia Spectrum and … section What is Olanzapine Mylan? Olanzapine Mylan is a medicine containing … 15 and 20 mg). Olanzapine Mylan is a ‘ generic medicine’. This means that … -
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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: 5, Authorised, Last updated: 22/02/2023
Azacitidine Mylan Bone Marrow Diseases Hematologic … 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): Docetaxel Mylan
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 31/01/2012,, Revision: 6, Withdrawn, Last updated: 12/03/2015
Docetaxel Mylan Head and Neck Neoplasms Carcinoma … oduct details Name Docetaxel Mylan Agency product number EMEA/H/C/002317 … chemical (ATC) code L01CD02 Generic Generic Generic This is a … -
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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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Human medicine European public assessment report (EPAR): Teriflunomide Mylan
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Revision: 1, Authorised, Last updated: 16/01/2023
Teriflunomide Mylan Multiple Sclerosis Demyelinating … Teriflunomide Mylan is a medicine used to treat … themselves. Teriflunomide Mylan is used in the type of MS … -
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 4, Authorised, Last updated: 02/05/2023
Fingolimod Mylan Multiple Sclerosis, Relapsin … Fingolimod Mylan is a medicine used to treat … remissions). Fingolimod Mylan is used when the disease … -
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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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Human medicine European public assessment report (EPAR): Lenalidomide Mylan
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Revision: 7, Authorised, Last updated: 05/10/2022
Lenalidomide Mylan Cancer Neoplasms Neoplasms … lymphocytes, Lenalidomide Mylan is used in adults whose disease … with rituximab. Lenalidomide Mylan contains the active substance … -
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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 … Overview On 27 May 2016, Mylan SAS officially notified the … Alendronic Acid/Colecalciferol Mylan, for the treatment of postmenopausal … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Revision: 4, Authorised, Last updated: 29/03/2023
Arsenic trioxide Mylan Cancer Neoplasms Leukemia … Arsenic trioxide Mylan is used to treat adults (aged … vitamin A). Arsenic trioxide Mylan is used in: patients with … -
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 13, Authorised, Last updated: 23/05/2023
Darunavir Mylan Blood-Borne Infections Communicable … 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): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 4, Authorised, Last updated: 26/04/2023
Ambrisentan Mylan Lung Diseases Respiratory … ambrisentan Overview Ambrisentan Mylan is a medicine that is used … of the lungs. Ambrisentan Mylan is used in patients with … -
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Human medicine European public assessment report (EPAR): Ritonavir Mylan (updated)
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 14, Authorised, Last updated: 17/05/2023
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): Febuxostat Mylan (updated)
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,, Revision: 11, Authorised, Last updated: 16/05/2023
Febuxostat Mylan Pathological Conditions … report (EPAR) for Febuxostat Mylan. It explains how the Agency … on how to use Febuxostat Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 3, Authorised, Last updated: 12/12/2022
Dimethyl fumarate Mylan Nervous System Diseases Autoimmune … Dimethyl fumarate Mylan is a medicine used to treat … remissions). Dimethyl fumarate Mylan contains the active substance … -
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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: 9, Authorised, Last updated: 28/03/2023
Deferasirox Mylan Nutritional and Metabolic … deferasirox Overview Deferasirox Mylan is a medicine used to treat … from the gut. Deferasirox Mylan contains the The substance …