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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): Abseamed
epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 11, Authorised, Last updated: 24/08/2020
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,
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, Authorised, Last updated: 24/11/2020
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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,, , , Revision: 28, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Alpheon
recombinant human interferon alfa-2a, Hepatitis C, Chronic
Date of refusal: 05/09/2006,, Refused, Last updated: 28/06/2006
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Human medicine European public assessment report (EPAR): Amgevita
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): 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): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 23/03/2010,, Revision: 1, Withdrawn, Last updated: 25/10/2011
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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): Bemfola
follitropin alfa, Anovulation
Date of authorisation: 26/03/2014,, Revision: 8, Authorised, Last updated: 10/01/2019
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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): Binocrit
epoetin alfa, Anemia, Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 20, Authorised, Last updated: 31/10/2019
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Human medicine European public assessment report (EPAR): Biograstim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 8, Withdrawn, Last updated: 19/01/2017
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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): 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): Bosulif
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013,, , Revision: 19, Authorised, Last updated: 09/12/2019
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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): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, , Revision: 4, Authorised, Last updated: 27/10/2020
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Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 19, Authorised, Last updated: 23/09/2020
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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): Crysvita
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 6, Authorised, Last updated: 04/11/2020
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Human medicine European public assessment report (EPAR): Cyltezo
adalimumab, Hidradenitis Suppurativa, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing
Date of authorisation: 10/11/2017,, , Revision: 2, Withdrawn, Last updated: 06/03/2019
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Human medicine European public assessment report (EPAR): Deltyba (updated)
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): Epoetin Alfa Hexal
epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer
Date of authorisation: 27/08/2007,, Revision: 22, Authorised, Last updated: 09/10/2019