612 results
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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 … MEDICINAL PRODUCT Azacitidine Mylan 25 mg/mL powder for suspension … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 16, Authorised, Last updated: 13/01/2023
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): 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 … EMEA/H/C/005962 Teriflunomide Mylan (teriflunomide) 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: 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 … -
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Human medicine European public assessment report (EPAR): Entecavir Mylan
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 6, Authorised, Last updated: 19/04/2023
Entecavir Mylan Infections Communicable … Entecavir Mylan … for the public Entecavir Mylan entecavir This is a summary … -
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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Date of authorisation: 31/01/2012,, Revision: 6, Withdrawn, Last updated: 12/03/2015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 … Docetaxel Mylan … 1 Public statement Docetaxel Mylan Cessation of validity of … -
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Human medicine European public assessment report (EPAR): Sugammadex Mylan
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/11/2021,, Revision: 2, Authorised, Last updated: 21/06/2023
Sugammadex Mylan Protective Agents Specialty … sugammadex Overview Sugammadex Mylan is a medicine used to reverse … the operation. Sugammadex Mylan is used to speed up the recovery … -
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Human medicine European public assessment report (EPAR): Fingolimod Mylan
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 Overview Fingolimod Mylan is a medicine used to treat … remissions). Fingolimod Mylan is used when the disease … -
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 8, Authorised, Last updated: 11/05/2023
Anagrelide Mylan Cancer Neoplasms Blood … report (EPAR) for Anagrelide Mylan. It explains how the Agency … on how to use Anagrelide Mylan. For practical information … -
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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: 15, Authorised, Last updated: 26/04/2023
Cinacalcet Mylan Nutritional and Metabolic … Cinacalcet Mylan … Cinacalcet Mylan, INN-cinacalcet 30 … -
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Human medicine European public assessment report (EPAR): Memantine Mylan
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 10, Authorised, Last updated: 29/03/2023
Memantine Mylan Nervous System Diseases Central … report (EPAR) for Memantine Mylan. It explains how the Agency … advice on how to use Memantine Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Rasagiline Mylan
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 7, Authorised, Last updated: 23/02/2023
Rasagiline Mylan Nervous System Diseases Central … report (EPAR) for Rasagiline Mylan. It explains how the Agency … on how to use Rasagiline Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan Pharma
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 25/06/2015,, Revision: 7, Withdrawn, Last updated: 26/04/2022
Pregabalin Mylan Pharma Mental Disorders Nervous … authorisation for Pregabalin Mylan Pharma has been withdrawn … Summary documents Pregabalin Mylan Pharma : EPAR - Summary for … -
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Human medicine European public assessment report (EPAR): Prasugrel Mylan
prasugrel besilate, Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable
Date of authorisation: 15/05/2018,, Revision: 8, Authorised, Last updated: 28/06/2022
Prasugrel Mylan Cardiovascular Diseases Heart … Prasugrel Mylan … Prasugrel Mylan overview 30 Churchill … -
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,, Revision: 16, Authorised, Last updated: 25/05/2023
Lopinavir/Ritonavir Mylan Blood-Borne Infections Communicable … Lopinavir/Ritonavir Mylan … public Lopinavir/Ritonavir Mylan lopinavir / ritonavir This … -
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Human medicine European public assessment report (EPAR): Atazanavir Mylan
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,, Revision: 14, Authorised, Last updated: 17/05/2023
Atazanavir Mylan Immunologic Deficiency Syndromes Immune … Atazanavir Mylan … Atazanavir Mylan, INN: atazanavir 30 … -
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Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 4, Authorised, Last updated: 11/09/2023
Abiraterone Mylan Cancer Neoplasms Genital … acetate Overview Abiraterone Mylan is a cancer medicine used … metastatic). Abiraterone Mylan is used together with prednisone … -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 18, Authorised, Last updated: 20/09/2022
Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … for Tenofovir disoproxil Mylan. It explains how the Agency … use Tenofovir disoproxil Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 4, Authorised, Last updated: 08/09/2023
Dimethyl fumarate Mylan Nervous System Diseases Autoimmune … Dimethyl fumarate Mylan … EMEA/H/C/005956 Dimethyl fumarate Mylan (dimethyl fumarate) An overview … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 14, Authorised, Last updated: 20/04/2023
Zoledronic acid Mylan Wounds and Injuries Fractures … EPAR) for Zoledronic acid Mylan. It explains how the Committee … of use for Zoledronic acid Mylan. What is Zoledronic acid Mylan? Zoledronic acid Mylan is a medicine that contains … -
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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 … PRODUCT Arsenic trioxide Mylan 1 mg/ml concentrate for solution … -
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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 11, Authorised, Last updated: 17/08/2023
Amlodipine / Valsartan Mylan Cardiovascular Diseases Vascular … for Amlodipine/Valsartan Mylan. It explains how the Agency … use Amlodipine/Valsartan Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 16, Authorised, Last updated: 08/09/2023
Aripiprazole Mylan Pharma (previously Aripiprazole … report (EPAR) for Aripiprazole Mylan Pharma. It explains how the … on how to use Aripiprazole Mylan Pharma. For practical information … -
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Human medicine European public assessment report (EPAR): Ribavirin Mylan (previously Ribavirin Three Rivers)
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 10/06/2010,, Revision: 10, Withdrawn, Last updated: 23/11/2020
Ribavirin Mylan (previously Ribavirin Three … Ribavirin Mylan (previously Ribavirin Three … for the public Ribavirin Mylan1 ribavirin This document … -
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News: Public Statement on Ziagen (Abacavir) - Abacavir hypersensitivity cases following an interruption of therapy
Last updated: 14/08/2000Public Statement on Ziagen (Abacavir Abacavir hypersensitivity cases following … prescribing or taking Ziagen (abacavir)1. The European Agency's … reactions associated with Ziagen (abacavir). Hypersensitivity reactions …