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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,,
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, Revision: 7, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Clopidogrel Mylan
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 16, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Ledaga
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 5, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Polivy
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,,
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, Revision: 2, Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
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, Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013,,
, Revision: 18, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Marixino (previously Maruxa)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 28/04/2013,, Revision: 7, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 10, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Pramipexole Accord
pramipexole dihydrochloride monohydrate, Parkinson Disease, Restless Legs Syndrome
Date of authorisation: 29/09/2011,, Revision: 10, Authorised, Last updated: 11/12/2020
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Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,,
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, Revision: 5, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,,
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, Revision: 6, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Vizarsin
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 15, Authorised, Last updated: 10/12/2020
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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: 9, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,,
, Revision: 1, Authorised, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Aybintio
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,,
, Revision: 1, Authorised, Last updated: 09/12/2020
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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: 9, Authorised, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Atazanavir Mylan
atazanavir (as sulphate), HIV Infections
Date of authorisation: 22/08/2016,, Revision: 9, Authorised, Last updated: 08/12/2020
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 8, Authorised, Last updated: 08/12/2020
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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: 6, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Onpattro
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,,
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, Revision: 8, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Iasibon
ibandronic acid, Hypercalcemia, Fractures, Bone, Neoplasm Metastasis, Breast Neoplasms
Date of authorisation: 21/01/2011,, Revision: 9, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,,
, Revision: 24, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm
desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 9, Authorised, Last updated: 03/12/2020
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Human medicine European public assessment report (EPAR): Esbriet
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 27/02/2011,, Revision: 26, Authorised, Last updated: 03/12/2020
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Human medicine European public assessment report (EPAR): Levetiracetam Hospira
levetiracetam, Epilepsy
Date of authorisation: 07/01/2014,, Revision: 15, Authorised, Last updated: 03/12/2020