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Human medicine European public assessment report (EPAR): Mylotarg

gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018, , , Revision: 7, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Adcetris

Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012, , , , Revision: 28, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Idacio

adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease
Date of authorisation: 02/04/2019, , , Revision: 5, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene)

Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013, , , Revision: 17, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Isturisa

Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020, , , Revision: 3, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Deltyba

Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013, , , , Revision: 14, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Ocaliva

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , 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, , , , 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, , , , 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, , , , 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, , , , 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