7996 results
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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 … 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): 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Date of authorisation: 25/06/2015,, Revision: 7, Withdrawn, Last updated: 26/04/2022
Pregabalin Mylan Pharma Mental Disorders Nervous … authorisation for Pregabalin Mylan Pharma has been withdrawn … Summary documents Pregabalin Mylan Pharma : EPAR - Summary for … -
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Withdrawn application: Alendronic Acid / Colecalciferol Mylan
date of withdrawal: 27/05/2016, Initial authorisation, Last updated: 02/02/2017dronic Acid / Colecalciferol Mylan: Withdrawn application … Questions and answers on generic medicines What is a generic medicine? A generic medicine is a medicine that … dronic Acid / Colecalciferol Mylan Alendronic Acid / Colecalciferol … -
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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 … report (EPAR) for Entecavir Mylan. It explains how the Agency … advice on how to use Entecavir Mylan. For practical information … -
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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 is taken together with aspirin … supplying the heart. Prasugrel Mylan contains the active substance … -
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Human medicine European public assessment report (EPAR): Abiraterone Mylan
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): 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): Dimethyl fumarate Mylan
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 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): 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): 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): 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 … EPAR) for Lopinavir/Ritonavir Mylan. It explains how the Agency … to use Lopinavir/Ritonavir Mylan. For practical information … -
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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 … report (EPAR) for Atazanavir Mylan. It explains how the Agency … on how to use Atazanavir Mylan. For practical information … -
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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)
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 … oduct details Name Ribavirin Mylan (previously Ribavirin Three … chemical (ATC) code J05AB04 Generic Generic Generic This is a … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 16, Authorised, Last updated: 20/11/2023
itabine/Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan. It explains how the Agency … Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, patients should read the … -
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan
Acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 5, Authorised, Last updated: 27/09/2023
ogrel / Acetylsalicylic acid Mylan Cardiovascular Diseases Heart … Clopidogrel/Acetylsalicylic acid Mylan is a medicine used to prevent … Clopidogrel/Acetylsalicylic acid Mylan contains two The substance … -
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan
sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 2, Authorised, Last updated: 30/05/2023
Metformin hydrochloride Mylan Diabetes Mellitus Endocrine … Sitagliptin/Metformin hydrochloride Mylan is a medicine used to control … Sitagliptin/Metformin hydrochloride Mylan contains the The substance … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,, Revision: 14, Authorised, Last updated: 27/07/2023
itabine/Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Mylan is an HIV medicine that is … Emtricitabine/Tenofovir disoproxil Mylan is also used to help prevent … -
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Referral: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021associated names, including its generic/hybrid products … associated names, including its generic/hybrid products. The withdrawal … associated names, including its generic/hybrid products Outcome of a procedure … -
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Referral: Baytril injectable and generics
enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/2014Baytril injectable and generics … facts Baytril injectable and genericsenrofloxacinEMEA/V/A/097 Article 35 Community interest … Baytril injectable and generics - Art.35 - Background information … -
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Referral: Docetaxel Teva Generics
docetaxel, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/02/2011, EC decision date: 07/07/2011, Last updated: 03/07/2012Docetaxel Teva Generics … the medicine Docetaxel Teva Generics. The Agency's Committee for … benefits of Docetaxel Teva Generics outweigh its risks, and that … -
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Generic and hybrid applications
Last updated: 13/01/2021Generic and hybrid applications … from companies to market A generic medicine is a medicine that … company can only market a generic medicine once the 10-year …
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Generic and hybrid medicines
Last updated: 12/05/2017Generic and hybrid medicines … from companies to market A generic medicine is a medicine that … company can only market a generic medicine once the 10-year …
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Referral: Zanil and associated names, and generic products thereof
oxyclozanide, associated names: Zanil Suspension, Zanil Fluke Drench, Zanil Fluke Drench 34 mg/ml Oral Suspension, Article 35
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 28/09/2017, Last updated: 25/10/2017and associated names, and generic products thereof … and associated names, and generic products thereof. The Agency's … and associated names, and generic products thereof? The veterinary …