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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): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,,
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, Revision: 4, Authorised, Last updated: 12/06/2020
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Human medicine European public assessment report (EPAR): Bronchitol
mannitol, Cystic Fibrosis
Date of authorisation: 13/04/2012,, Revision: 15, Authorised, Last updated: 28/10/2020
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Human medicine European public assessment report (EPAR): Cablivi
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,,
, Revision: 4, Authorised, Last updated: 20/11/2020
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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): Carbaglu
carglumic acid, Amino Acid Metabolism, Inborn Errors, Propionic Acidemia
Date of authorisation: 24/01/2003,, Revision: 18, Authorised, Last updated: 27/03/2019
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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): Cerdelga
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,,
, Revision: 11, Authorised, Last updated: 06/01/2020
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous, Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,,
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, Revision: 3, Authorised, Last updated: 24/11/2017
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Human medicine European public assessment report (EPAR): Coagadex
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,,
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, Revision: 5, Authorised, Last updated: 21/04/2020
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Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,,
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, 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): COVID-19 Vaccine Moderna
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: 20/01/2021
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Human medicine European public assessment report (EPAR): Cresemba
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 9, Authorised, Last updated: 26/08/2020
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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,,
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, 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): Cystadrops
mercaptamine hydrochloride, Cystinosis
Date of authorisation: 18/01/2017,, Revision: 7, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Dacogen
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,, Revision: 13, Authorised, Last updated: 13/05/2019
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,,
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, Revision: 14, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Daurismo (updated)
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,,
, Revision: 1, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,,
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, Revision: 12, Authorised, Last updated: 05/11/2020
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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,,
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, Revision: 14, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Dropcys
mercaptamine, Corneal Diseases, Cystinosis
Date of refusal: 24/06/2016,, Refused, Last updated: 25/07/2016
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Human medicine European public assessment report (EPAR): Elelyso
Taliglucerase alfa, Gaucher Disease
Date of refusal: 25/10/2012,, Refused, Last updated: 23/11/2012