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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,
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, Revision: 24, Authorised, Last updated: 13/03/2019
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Human medicine European public assessment report (EPAR): Adempas
riociguat, Hypertension, Pulmonary
Date of authorisation: 27/03/2014,, Revision: 10, Authorised, Last updated: 29/04/2019
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Human medicine European public assessment report (EPAR): Aldurazyme
laronidase, Mucopolysaccharidosis I
Date of authorisation: 09/06/2003, Revision: 18, Authorised, Last updated: 21/02/2019 -
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Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 4, Authorised, Last updated: 12/02/2020
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Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,, , Revision: 4, Authorised, Last updated: 10/04/2019
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 3, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Besponsa
inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,, , Revision: 6, Authorised, Last updated: 10/01/2020
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Human medicine European public assessment report (EPAR): Blincyto
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 10, Authorised, Last updated: 05/11/2019
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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: 3, Authorised, Last updated: 19/02/2020
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Human medicine European public assessment report (EPAR): Bronchitol
mannitol, Cystic Fibrosis
Date of authorisation: 13/04/2012,, Revision: 14, Authorised, Last updated: 04/02/2020
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Human medicine European public assessment report (EPAR): Cablivi
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,, , Revision: 2, Authorised, Last updated: 14/03/2019
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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): 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,, , , 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,, , , Revision: 4, Authorised, Last updated: 22/10/2019
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 17, Authorised, Last updated: 10/03/2020
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, , Revision: 8, Authorised, Last updated: 23/03/2020
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Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 5, Authorised, Last updated: 06/03/2020
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Human medicine European public assessment report (EPAR): Cystadrops
mercaptamine hydrochloride, Cystinosis
Date of authorisation: 18/01/2017,, Revision: 5, Authorised, Last updated: 14/06/2019
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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,, , , Revision: 11, Authorised, Last updated: 23/01/2020
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 10, Authorised, Last updated: 19/11/2019
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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: 12, Authorised, Last updated: 08/08/2019
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Human medicine European public assessment report (EPAR): Diacomit
stiripentol, Myoclonic Epilepsy, Juvenile
Date of authorisation: 03/01/2007,
Date of refusal: 11/02/2009, Revision: 15, Authorised, Last updated: 07/12/2018 -
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 19, Authorised, Last updated: 27/11/2019