475 results
Keyword Cinacalcet Mylan Remove keyword
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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: 14, Authorised, Last updated: 12/09/2022
Cinacalcet Mylan Nutritional and Metabolic … Authorised cinacalcet Overview This is a summary … assessment report (EPAR) for Cinacalcet Mylan. It explains how the Agency … -
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 2, Authorised, Last updated: 26/01/2022
Cinacalcet Accordpharma Endocrine System … Cinacalcet Accordpharma … THE MEDICINAL PRODUCT Cinacalcet Accordpharma 30 mg film-coated … -
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Human medicine European public assessment report (EPAR): Mimpara (updated)
cinacalcet hydrochloride, Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
Date of authorisation: 22/10/2004, Revision: 25, Authorised, Last updated: 29/03/2023Authorised cinacalcet Overview This is a summary … medicine. active substance cinacalcet. How is Mimpara used? Mimpara … active substance in Mimpara, cinacalcet, is a calcimimetic agent … -
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Human medicine European public assessment report (EPAR): Parareg
cinacalcet, Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
Date of authorisation: 22/10/2004, Revision: 6, Withdrawn, Last updated: 14/05/2009Withdrawn cinacalcet Overview The marketing authorisation … STATEMENT ON Parareg (cinacalcet) WITHDRAWAL OF THE … medicinal product Parareg, cinacalcet. Parareg is approved for the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mimpara, cinacalcet hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000078-PIP01-07-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/05/2017, Last updated: 02/03/2018, Compliance check: V, 19/05/2017Mimpara Active substance cinacalcet hydrochloride Therapeutic … paediatric investigation plan for cinacalcet (hydrochloride) (Mimpara … paediatric investigation plan for cinacalcet (hydrochloride) (Mimpara … -
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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 … Clopidogrel Taw Pharma Clopidogrel Mylan received a The approval to … Pharma (previously Clopidogrel Mylan) : EPAR - Summary for the … -
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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 … Rotigotine Mylan: Withdrawal of the marketing … application for Rotigotine Mylan (rotigotine) On 22 December … -
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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: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015Aripiprazole Mylan: Withdrawn application … Aripiprazole Mylan: Withdrawal of the marketing … application for Aripiprazole Mylan (aripiprazole) On 7 May … -
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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 … Docetaxel Mylan: Withdrawal of the marketing … application for Docetaxel Mylan (docetaxel) On 8 March … -
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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: Alendronic Acid / Colecalciferol Mylan
date of withdrawal: 27/05/2016, Initial authorisation, Last updated: 02/02/2017dronic Acid / Colecalciferol Mylan: Withdrawn application … dronic Acid / Colecalciferol Mylan: Withdrawal of the marketing … Alendronic Acid/Colecalciferol Mylan (alendronic acid and colecalciferol … -
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Human medicine European public assessment report (EPAR): Fulvestrant Mylan
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 5, Authorised, Last updated: 24/02/2023
Fulvestrant Mylan Neoplasms Cancer Breast … 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): Febuxostat Mylan (updated)
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,, Revision: 9, Authorised, Last updated: 29/03/2023
Febuxostat Mylan Pathological Conditions … 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): Deferasirox Mylan (updated)
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): 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 Overview 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): 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): Olanzapine Mylan
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 18, Authorised, Last updated: 17/01/2023
Olanzapine Mylan Schizophrenia Spectrum and … EPAR). What is Olanzapine Mylan? Olanzapine Mylan is a medicine containing … 15 and 20 mg). Olanzapine Mylan is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 1, Authorised, Last updated: 09/03/2023
Rivaroxaban Mylan Cardiovascular Diseases Vascular … rivaroxaban Overview Rivaroxaban Mylan is an anticoagulant medicine … with aspirin. Rivaroxaban Mylan contains the The substance … -
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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): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 12, Authorised, Last updated: 04/11/2022
Darunavir Mylan Blood-Borne Infections Communicable … Darunavir Mylan … Darunavir Mylan, INN-darunavir 30 … -
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 13, Authorised, Last updated: 12/10/2022
Ritonavir Mylan Blood-Borne Infections Communicable … Ritonavir Mylan … for the public Ritonavir Mylan ritonavir This is a summary … -
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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 … Lenalidomide Mylan … EMEA/H/C/005306 Lenalidomide Mylan (lenalidomide) An overview … -
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Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 8, Authorised, Last updated: 15/07/2022
Zonisamide Mylan Brain Diseases Central … 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): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 3, Authorised, Last updated: 29/06/2022
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 …