2793 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: 5, Authorised, Last updated: 01/12/2020
lmanco (previously Tadalafil Generics) Hypertension, Pulmonary … Talmanco (previously Tadalafil Generics) Agency product number EMEA/H/C/004297 … chemical (ATC) code G04BE08 Generic Generic Generic This is a … -
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Withdrawn application: Pioglitazone Teva Generics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date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn application … authorisation) Pioglitazone Teva Generics pioglitazone On 22 September … product Pioglitazone Teva Generics 15, 30, 45 mg tablet intended … -
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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Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016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 … Zoledronic acid Teva Generics … Zoledronic acid Teva Generics, INN-zoledronic acid … -
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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Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014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 … Clopidogrel Teva Generics B.V … Questions and answers on generic medicines What is a generic medicine? A generic medicine is a medicine that … -
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Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018Rotigotine Mylan: Withdrawn application … Questions and answers on generic medicines What is a generic medicine? A generic medicine is a medicine that … Rotigotine Mylan Rotigotine Mylan rotigotine rotigotine … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 08/01/2016, Initial authorisation, Last updated: 29/03/2016Aripiprazole Mylan: Withdrawn application … application for Aripiprazole Mylan (aripiprazole) On 8 January … aripiprazole) On 8 January 2016, Mylan S.A.S. officially notified … -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 … aripiprazole) On 7 May 2015, Generics (UK) Limited officially notified … -
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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: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … Questions and answers on generic medicines What is a generic medicine? A generic medicine is a medicine that … Docetaxel Mylan Docetaxel Mylan docetaxel docetaxel … -
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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): 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 … report (EPAR) for Zonisamide Mylan. It explains how the Agency … on how to use Zonisamide 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 … 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): 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 … 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): 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 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): Fulvestrant Mylan
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 4, Authorised, Last updated: 15/10/2020
Fulvestrant Mylan Breast Neoplasms … report (EPAR) for Fulvestrant Mylan. It explains how the Agency … on how to use Fulvestrant Mylan. For practical information … -
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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 is a cancer medicine used … receptor (EGFR). Gefitinib Mylan contains the active substance … -
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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 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): 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 … 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): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 11, Authorised, Last updated: 17/01/2020
Tadalafil Mylan Erectile Dysfunction … report (EPAR) for Tadalafil Mylan. It explains how the Agency … advice on how to use Tadalafil 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: 4, Authorised, Last updated: 18/05/2020
Febuxostat Mylan Hyperuricemia Arthritis … 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): 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 … 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
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Authorised, Last updated: 07/01/2021
Lenalidomide Mylan Multiple Myeloma … lymphocytes, Lenalidomide Mylan is used in adults whose disease … with rituximab. Lenalidomide Mylan contains the The substance … -
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Human medicine European public assessment report (EPAR): Cinacalcet Mylan
cinacalcet hydrochloride, Hyperparathyroidism, Secondary, Hypercalcemia
Date of authorisation: 19/11/2015,, Revision: 9, Authorised, Last updated: 10/12/2020
Cinacalcet Mylan Hyperparathyroidism, Seconda … report (EPAR) for Cinacalcet Mylan. It explains how the Agency … on how to use Cinacalcet Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 3, Authorised, Last updated: 25/02/2021
Entecavir Mylan Hepatitis B … report (EPAR) for Entecavir Mylan. It explains how the Agency … advice on how to use Entecavir Mylan. For practical information …