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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,, Revision: 30, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Sixmo (updated)
Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019,, Revision: 2, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Rybelsus (updated)
semaglutide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2020,, Revision: 2, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Laventair Ellipta (previously Laventair) (updated)
umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 14, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Mylotarg (updated)
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): Quofenix (updated)
delafloxacin meglumine, Skin Diseases, Bacterial
Date of authorisation: 16/12/2019,, Revision: 2, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Gilenya (updated)
fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011,,
, Revision: 27, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,,
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, Revision: 28, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Biktarvy (updated)
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018,, Revision: 10, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Idacio (updated)
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) (updated)
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): Erleada (updated)
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 2, Authorised, Last updated: 17/12/2020
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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): Revlimid
lenalidomide, Multiple Myeloma, Lymphoma, Mantle-Cell, Myelodysplastic Syndromes
Date of authorisation: 14/06/2007,, Revision: 43, 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,,
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, 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,,
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, Revision: 7, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Quinsair
levofloxacin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 25/03/2015,, Revision: 12, Authorised, Last updated: 15/12/2020
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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): Olumiant
baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017,, Revision: 8, 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): Xeljanz
tofacitinib citrate, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,
Date of refusal: 25/04/2013,,
, Revision: 15, Authorised, Last updated: 14/12/2020
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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): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight
Date of authorisation: 26/03/2015,, Revision: 18, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Orkambi
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015,, Revision: 24, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,,
, Revision: 13, Authorised, Last updated: 11/12/2020