19483 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 Diseases Cardiovascular … tadalafil. Talmanco is a ‘generic medicine’. This means that … work? PAH is a debilitating disease where there is severe narrowing … -
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Withdrawn application: Diractin
date of withdrawal: 23/07/2008, Initial authorisation, Last updated: 24/07/2008Diractin: Withdrawn application … Diractin, INN ketoprofen European Medicines … marketing application for Diractin International non-proprietary … -
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Withdrawn application: Pioglitazone Teva Generics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date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn application … On 26 January 2012, Teva Generics B.V. officially notified … authorisation for Pioglitazone Teva Generics, for the treatment of type-2 diabetes. What is Pioglitazone Teva … -
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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Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014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 Diseases Acute Coronary Syndrome Myocardial … 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): 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 Diseases of the Nervous System Demyelinating … Dimethyl fumarate Mylan is a medicine used to treat … multiple sclerosis (MS), a disease in which inflammation damages … -
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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: 16, Authorised, Last updated: 20/09/2022
Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … Infections Communicable Diseases Infections Sexually Transmitted … ctions Sexually Transmitted Diseases Sexually Transmitted … -
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Referral: Ketoprofen topical
ketoprofen, associated names: Fastum, Ketum, Orudis, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 22/07/2010, EC decision date: 29/11/2010, Last updated: 28/10/2011Ketoprofen topical … procedure under Article 107 of Directive 2001/83/EC The European Medicines … safety and effectiveness of ketoprofen-containing medicines used topically … -
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Referral: Dolovet Rifen
ketoprofen, Article 33
Status: European Commission final decision, opinion/position date: 09/11/2006, EC decision date: 17/04/2007, Last updated: 07/12/201115g, each containing 2.4g ketoprofen and is authorised for the … procedure under Article 33(4) of Directive 2001/82/EC, as amended. The … the number of animals used did not allow equivalence to … -
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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: 12, Authorised, Last updated: 06/02/2023
Emtricitabine/Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … Infections Communicable Diseases Infections Sexually Transmitted … ctions Sexually Transmitted Diseases Sexually Transmitted … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 13, Authorised, Last updated: 14/09/2022
renz/Emtricitabine/Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … Infections Communicable Diseases Infections Sexually Transmitted … ctions Sexually Transmitted Diseases Sexually Transmitted … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): ketoprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001783-PIP02-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Medicated plaster
Decision date: 21/12/2015, Last updated: 02/02/2016, Compliance check: XKey facts ketoprofen PainP/0317/2015EMEA-001783-PIP02-15 … product-specific waiver for ketoprofen (EMEA-001783-PIP02-15) PDF … 02/02/2016 EMA/807033/2015 Generic Topics: Paediatrics … -
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Referral: Ketoprofene Ethypharm LP
ketoprofen, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 29/06/2000, EC decision date: 27/12/2000, Last updated: 28/12/2000Ketoprofene Ethypharm LP … to article 10 of Council Directive 75/319/EEC as amended for … 2001 Reproduction and/or distribution of this document is authorised … -
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Opinion/decision on a Paediatric investigation plan (PIP): ketoprofen, omeprazole
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001361-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Modified release capsule
Decision date: 03/07/2013, Last updated: 13/08/2013, Compliance check: XKey facts ketoprofen omeprazole PainP/0148/2013EMEA-001361-PIP01-12 … product-specific waiver for ketoprofen / omeprazole (EMEA-001361-PIP01-12 … 13/08/2013 EMA/316683/2013 Generic Topics: Paediatrics … -
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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 Diseases Nervous System … stroke; peripheral arterial disease (problems with blood flow … clopidogrel and is a ‘ A generic medicine is a medicine that … -
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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 … Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous … Nervous System Nervous System Diseases Demyelinating … -
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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 System Diseases Central Nervous System Diseases Brain … 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): 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 Diseases Peripheral Nervous System Diseases Pathological Conditions … 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): 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,, Revision: 2, Authorised, Last updated: 21/04/2023
Rivaroxaban Mylan Cardiovascular Diseases Vascular Diseases Heart Diseases Myocardial Ischemia Coronary … rivaroxaban Overview Rivaroxaban Mylan is an anticoagulant medicine … stroke or death from heart disease) in adults: after an acute … -
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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 … Infections Communicable Diseases Infections Sexually Transmitted … ctions Sexually Transmitted Diseases Sexually Transmitted … -
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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 … Plasma Cell Cardiovascular Diseases Vascular Diseases Hemostatic Disorders Hemic and Lymphatic … lymphocytes, Lenalidomide Mylan is used in adults whose disease has come back after treatment … -
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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 Tract Diseases Cardiovascular Diseases Cardiovascular … 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): 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 … Infections Communicable Diseases Infections Sexually Transmitted … ctions Sexually Transmitted Diseases Sexually Transmitted … -
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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 Nervous System Diseases Brain Diseases Basal Ganglia … 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): 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 Nervous System Diseases Brain Diseases Dementia Neurodegenerative … report (EPAR) for Memantine Mylan. It explains how the Agency … advice on how to use Memantine Mylan. For practical information …