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Human medicine European public assessment report (EPAR): Silapo (updated)
epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic
Date of authorisation: 18/12/2007,
, Revision: 16, Authorised, Last updated: 07/04/2020
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,
, , Revision: 2, Authorised, Last updated: 02/04/2020
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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, , Revision: 4, Authorised, Last updated: 01/04/2020
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Human medicine European public assessment report (EPAR): Grasustek (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, , Revision: 1, Authorised, Last updated: 31/03/2020
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Human medicine European public assessment report (EPAR): Kromeya (updated)
adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease
Date of authorisation: 02/04/2019,, , Revision: 4, Withdrawn, Last updated: 25/03/2020
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Human medicine European public assessment report (EPAR): Trazimera (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018,, , Revision: 5, Authorised, Last updated: 24/03/2020
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi (updated)
insulin lispro, Diabetes Mellitus
Date of authorisation: 18/07/2017,, , Revision: 5, Authorised, Last updated: 24/03/2020
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Arthritis, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 24/08/2017,, , Revision: 11, Authorised, Last updated: 20/03/2020
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Human medicine European public assessment report (EPAR): Ogivri (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 3, Authorised, Last updated: 18/03/2020
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Human medicine European public assessment report (EPAR): Hulio (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 16/09/2018,, , Revision: 4, Authorised, Last updated: 17/03/2020
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 8, Authorised, Last updated: 17/03/2020
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Human medicine European public assessment report (EPAR): Amgevita (updated)
adalimumab, Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,, , Revision: 8, Authorised, Last updated: 12/03/2020
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Human medicine European public assessment report (EPAR): Inhixa
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 13, Authorised, Last updated: 04/03/2020
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Human medicine European public assessment report (EPAR): Ratiograstim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 11, Authorised, Last updated: 02/03/2020
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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: 18, Authorised, Last updated: 27/02/2020
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Human medicine European public assessment report (EPAR): Zirabev
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 4, Authorised, Last updated: 26/02/2020
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,, , Revision: 7, Authorised, Last updated: 14/02/2020
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Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, , Revision: 5, Authorised, Last updated: 10/02/2020
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Human medicine European public assessment report (EPAR): Tevagrastim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 12, Authorised, Last updated: 05/02/2020
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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: 11, Authorised, Last updated: 30/01/2020
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Human medicine European public assessment report (EPAR): Grastofil
filgrastim, Neutropenia
Date of authorisation: 17/10/2013,, Revision: 11, Authorised, Last updated: 28/01/2020
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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: 3, Authorised, Last updated: 28/01/2020
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Human medicine European public assessment report (EPAR): Movymia
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, , Revision: 6, Authorised, Last updated: 21/01/2020
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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: 25, Authorised, Last updated: 14/01/2020
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Human medicine European public assessment report (EPAR): Ziextenzo
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, , Revision: 2, Authorised, Last updated: 13/01/2020