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129 results
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
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, Revision: 15, Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, 
, Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 4, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 8, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 17, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 27, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 14, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, , Revision: 12, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Holoclar (updated)
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 7, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 1, Authorised, Last updated: 12/01/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 8, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, 
, Revision: 9, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Livogiva (updated)
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, , Revision: 1, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 7, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Erelzi (updated)
etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, , Revision: 8, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, , Revision: 7, 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): 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): 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): 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): 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