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116 results
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,
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, 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 (updated)
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): 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): 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): 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): 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): 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): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, , Revision: 18, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 5, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Remsima
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 21, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Amsparity
adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, Hidradenitis Suppurativa
Date of authorisation: 13/02/2020,, , Revision: 1, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Benepali
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, Revision: 12, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Retacrit
epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer
Date of authorisation: 18/12/2007,, Revision: 27, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Nepexto
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 2, Authorised, Last updated: 26/11/2020