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Human medicine European public assessment report (EPAR): Besponsa (updated)
inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,
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, Revision: 7, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Memantine LEK (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,
Date of refusal: 21/02/2013,
, Revision: 5, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Repaglinide Krka (updated)
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/11/2009,, Revision: 6, Authorised, Last updated: 12/11/2020
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Human medicine European public assessment report (EPAR): Xermelo (updated)
telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors
Date of authorisation: 17/09/2017,, , Revision: 11, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz (updated)
ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 8, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Atosiban SUN (updated)
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,, Revision: 8, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , 
, Revision: 1, Authorised, Last updated: 09/11/2020
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , Revision: 1, Authorised, Last updated: 06/11/2020
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosylate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 11, Authorised, Last updated: 06/11/2020
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Human medicine European public assessment report (EPAR): Defitelio (updated)
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , 
, Revision: 12, Authorised, Last updated: 05/11/2020
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Human medicine European public assessment report (EPAR): Pemetrexed Accord (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 5, Authorised, Last updated: 05/11/2020
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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: 6, Authorised, Last updated: 04/11/2020
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Human medicine European public assessment report (EPAR): Alprolix (updated)
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,, , Revision: 5, Authorised, Last updated: 04/11/2020
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Human medicine European public assessment report (EPAR): NexoBrid (updated)
concentrate of proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, , Revision: 10, Authorised, Last updated: 03/11/2020
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Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, 
, , Revision: 10, Authorised, Last updated: 03/11/2020
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Human medicine European public assessment report (EPAR): Palynziq (updated)
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,, , Revision: 1, Authorised, Last updated: 30/10/2020
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Human medicine European public assessment report (EPAR): Ifirmacombi
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 04/03/2011,, Revision: 11, Authorised, Last updated: 30/10/2020
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Human medicine European public assessment report (EPAR): Cinacalcet Mylan
cinacalcet hydrochloride, Hyperparathyroidism, Secondary, Hypercalcemia
Date of authorisation: 19/11/2015,, Revision: 8, Authorised, Last updated: 29/10/2020
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Human medicine European public assessment report (EPAR): Hetlioz
tasimelteon, Sleep Disorders, Circadian Rhythm
Date of authorisation: 03/07/2015,, Revision: 6, Authorised, Last updated: 29/10/2020
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
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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): Docetaxel Accord
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
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Human medicine European public assessment report (EPAR): Deferasirox Mylan
deferasirox, Iron Overload, beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 1, Authorised, Last updated: 27/10/2020
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Human medicine European public assessment report (EPAR): Onpattro
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, , , Revision: 7, Authorised, Last updated: 27/10/2020
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Human medicine European public assessment report (EPAR): Mozobil
Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma
Date of authorisation: 30/07/2009,, Revision: 19, Authorised, Last updated: 27/10/2020