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374 results
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Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,
, Revision: 11, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Alofisel (updated)
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, 
, Revision: 6, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, 
, Revision: 4, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, 
, Revision: 7, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Anoro Ellipta (previously Anoro)
umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 15, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 23, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Keytruda
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
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
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)
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
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
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
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
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): Biktarvy
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
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): Erleada
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,, , , Revision: 14, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 26, Authorised, Last updated: 16/12/2020
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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): 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): Quinsair
levofloxacin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 25/03/2015,, Revision: 12, Authorised, Last updated: 15/12/2020