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Medicine
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,,
, Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Neparvis (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,, Revision: 11, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Cinryze (updated)
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 19, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta) (updated)
umeclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/03/2017,, Revision: 9, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,,
, Revision: 11, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017,, Revision: 12, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,,
, Revision: 9, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Nepexto (updated)
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,,
, Revision: 3, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Kanjinti (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018,,
, Revision: 7, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,,
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, Revision: 11, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Besremi (updated)
ropeginterferon alfa-2b, Polycythemia Vera
Date of authorisation: 15/02/2019,, Revision: 1, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,,
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, Revision: 20, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Vizimpro (updated)
dacomitinib monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 02/04/2019,, Revision: 1, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Lyumjev (previously Liumjev) (updated)
insulin lispro, Diabetes Mellitus
Date of authorisation: 24/03/2020,, Revision: 2, Authorised, Last updated: 19/02/2021
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Human medicine European public assessment report (EPAR): Recarbrio (updated)
imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections
Date of authorisation: 13/02/2020,, Revision: 2, Authorised, Last updated: 19/02/2021
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Human medicine European public assessment report (EPAR): Nuceiva (updated)
Botulinum toxin type A, Skin Aging
Date of authorisation: 27/09/2019,, Revision: 2, Authorised, Last updated: 19/02/2021
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Human medicine European public assessment report (EPAR): Zavicefta (updated)
avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial, Soft Tissue Infections, Pneumonia, Urinary Tract Infections, Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016,, Revision: 11, Authorised, Last updated: 18/02/2021
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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,,
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, Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Enzepi (updated)
pancreas powder, Exocrine Pancreatic Insufficiency
Date of authorisation: 29/06/2016,, Revision: 1, Withdrawn, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 2, Authorised, Last updated: 16/02/2021
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Human medicine European public assessment report (EPAR): Udenyca (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,,
, Revision: 3, Withdrawn, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Ultomiris (updated)
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 4, Authorised, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Symtuza (updated)
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017,, Revision: 9, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Bavencio (updated)
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,, Revision: 8, Authorised, Last updated: 11/02/2021