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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 6, 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): Palonosetron Accord (updated)
Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
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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): Clopidogrel Taw Pharma (previously Clopidogrel Apotex) (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 20, Authorised, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 5, Authorised, Last updated: 17/02/2021
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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): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 8, 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): Mysildecard (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 3, 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
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 12, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 12, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Ritemvia (updated)
rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 13/07/2017,,
, Revision: 8, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Actavis Group (updated)
levetiracetam, Epilepsy
Date of authorisation: 04/12/2011,, Revision: 14, Authorised, Last updated: 10/02/2021
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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: 10, Authorised, Last updated: 10/02/2021