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332 results
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Human medicine European public assessment report (EPAR): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,
, Revision: 5, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Ibandronic acid Accord
ibandronic acid, Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
Date of authorisation: 18/11/2012,, Revision: 13, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d.
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 9, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 2, Authorised, Last updated: 08/04/2022
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Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 12, Authorised, Last updated: 08/04/2022
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Human medicine European public assessment report (EPAR): Palonosetron Hospira
palonosetron hydrochloride, Nausea; Vomiting; Cancer
Date of authorisation: 08/04/2016,, Revision: 4, Withdrawn, Last updated: 08/04/2022
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Human medicine European public assessment report (EPAR): Febuxostat Krka
febuxostat, Hyperuricemia; Gout
Date of authorisation: 28/03/2019,, Revision: 3, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Daptomycin Hospira
daptomycin, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 22/03/2017,, Revision: 13, Authorised, Last updated: 06/04/2022
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Human medicine European public assessment report (EPAR): Nimvastid
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009,, Revision: 9, Authorised, Last updated: 06/04/2022
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Human medicine European public assessment report (EPAR): Tigecycline Accord
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 3, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 4, Authorised, Last updated: 01/04/2022
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Human medicine European public assessment report (EPAR): Lenalidomide Accord
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 9, Authorised, Last updated: 31/03/2022
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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: 3, Authorised, Last updated: 30/03/2022
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Authorised, Last updated: 30/03/2022
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Authorised, Last updated: 30/03/2022
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Human medicine European public assessment report (EPAR): Temomedac
temozolomide, Glioma; Glioblastoma
Date of authorisation: 25/01/2010,, Revision: 15, Authorised, Last updated: 28/03/2022
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Human medicine European public assessment report (EPAR): Rivaroxaban Accord
rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020,, Revision: 2, Authorised, Last updated: 28/03/2022
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Human medicine European public assessment report (EPAR): Ciambra
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 02/12/2015,, Revision: 5, Authorised, Last updated: 28/03/2022
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 13, Authorised, Last updated: 25/03/2022
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 16, Authorised, Last updated: 25/03/2022
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Human medicine European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS)
nitisinone, Tyrosinemias
Date of authorisation: 24/08/2017,, Revision: 5, Authorised, Last updated: 24/03/2022
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Human medicine European public assessment report (EPAR): Carmustine Obvius
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 6, Authorised, Last updated: 24/03/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 21/03/2022