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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): 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): 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
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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): 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
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Human medicine European public assessment report (EPAR): Kevzara (updated)
sarilumab, Arthritis, Rheumatoid
Date of authorisation: 23/06/2017,, Revision: 5, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Trogarzo (updated)
Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019,, Revision: 3, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,,
, Revision: 8, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi) (updated)
Lusutrombopag, Thrombocytopenia
Date of authorisation: 18/02/2019,, Revision: 5, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,,
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, Revision: 1, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,,
, Revision: 2, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Imfinzi (updated)
durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018,, Revision: 7, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Kengrexal (updated)
cangrelor, Acute Coronary Syndrome, Vascular Surgical Procedures
Date of authorisation: 23/03/2015,, Revision: 9, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Beovu (updated)
brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020,, Revision: 2, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 24, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
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: 05/02/2021
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Human medicine European public assessment report (EPAR): Gilenya (updated)
fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011,,
, Revision: 28, Authorised, Last updated: 04/02/2021
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
Upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, Revision: 3, Authorised, Last updated: 03/02/2021
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Human medicine European public assessment report (EPAR): Xarelto (updated)
rivaroxaban, Arthroplasty, Replacement, Venous Thromboembolism
Date of authorisation: 30/09/2008,,
, Revision: 33, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,,
, Revision: 8, Authorised, Last updated: 02/02/2021