10468 results
-
List item
Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics) (updated)
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 … tadalafil. Talmanco is a ‘ A generic medicine is a medicine that … company can only market a generic medicine once the 10-year … -
List item
Withdrawn application: Pioglitazone Teva Generics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date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn application … Pioglitazone Teva Generics: Withdrawal of the marketing … authorisation) Pioglitazone Teva Generics pioglitazone On 22 September … -
List item
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Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016
Zoledronic acid Teva Generics Osteoporosis Osteitis Defor … for Zoledronic Acid Teva Generics has been withdrawn at the … documents Zoledronic acid Teva Generics : EPAR - Summary for the … -
List item
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Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014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 … -
List item
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 and is a ‘ A generic medicine is a medicine that … company can only market a generic medicine once the 10-year … -
List item
Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018Rotigotine Mylan: Withdrawn application … Overview On 22 December 2017, Mylan SAS officially notified the … authorisation for Rotigotine Mylan, for the treatment of Parkinson's … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … lymphocytes, Lenalidomide Mylan is used in adults whose disease … with rituximab. Lenalidomide Mylan contains the The substance … -
List item
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 … -
List item
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 … section What is Olanzapine Mylan? Olanzapine Mylan is a medicine containing … 15 and 20 mg). Olanzapine Mylan is a ‘ generic medicine’. This means that … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 2, Authorised, Last updated: 23/03/2021
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 … -
List item
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 … report (EPAR) for Febuxostat Mylan. It explains how the Agency … on how to use Febuxostat Mylan. For practical information … -
List item
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 … report (EPAR) for Zonisamide Mylan. It explains how the Agency … on how to use Zonisamide Mylan. For practical information … -
List item
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 … report (EPAR) for Darunavir Mylan. It explains how the Agency … advice on how to use Darunavir Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 13, Authorised, Last updated: 28/09/2021
Tadalafil Mylan Mental Disorders Sexual … report (EPAR) for Tadalafil Mylan. It explains how the Agency … advice on how to use Tadalafil Mylan. For practical information …