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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 3, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Reblozyl (updated)
Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia
Date of authorisation: 25/06/2020,,
, Revision: 1, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Urologic Neoplasms
Date of authorisation: 19/06/2015, Revision: 36, Authorised, Last updated: 21/04/2021 -
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 7, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Samsca (updated)
Tolvaptan, Inappropriate ADH Syndrome
Date of authorisation: 02/08/2009, Revision: 14, Authorised, Last updated: 21/04/2021 -
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Human medicine European public assessment report (EPAR): Telzir (updated)
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 46, Authorised, Last updated: 21/04/2021 -
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Human medicine European public assessment report (EPAR): Herceptin (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 28/08/2000, Revision: 39, Authorised, Last updated: 21/04/2021 -
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA 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: 21/12/2020,,
, Revision: 5, Authorised, Last updated: 20/04/2021
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Human medicine European public assessment report (EPAR): Tecfidera (updated)
dimethyl fumarate, Multiple Sclerosis
Date of authorisation: 30/01/2014, Revision: 21, Authorised, Last updated: 20/04/2021 -
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Human medicine European public assessment report (EPAR): Vfend (updated)
voriconazole, Candidiasis, Mycoses, Aspergillosis
Date of authorisation: 19/03/2002, Revision: 48, Authorised, Last updated: 20/04/2021 -
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Human medicine European public assessment report (EPAR): Zykadia (updated)
ceritinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2015,, Revision: 14, Authorised, Last updated: 20/04/2021
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Human medicine European public assessment report (EPAR): Exforge (updated)
valsartan, amlodipine (as amlodipine besilate), Hypertension
Date of authorisation: 16/01/2007, Revision: 27, Authorised, Last updated: 20/04/2021 -
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Human medicine European public assessment report (EPAR): Vipidia (updated)
alogliptin, Diabetes Mellitus, Type 2
Date of authorisation: 18/09/2013, Revision: 6, Authorised, Last updated: 20/04/2021 -
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 2, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Tafinlar (updated)
dabrafenib mesilate, Melanoma
Date of authorisation: 26/08/2013, Revision: 24, Authorised, Last updated: 19/04/2021 -
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Human medicine European public assessment report (EPAR): Lonquex (updated)
lipegfilgrastim, Neutropenia
Date of authorisation: 25/07/2013, Revision: 20, Authorised, Last updated: 19/04/2021 -
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Human medicine European public assessment report (EPAR): Mekinist (updated)
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 21, Authorised, Last updated: 19/04/2021 -
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Human medicine European public assessment report (EPAR): Prometax (updated)
rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia
Date of authorisation: 03/12/1998, Revision: 39, Authorised, Last updated: 19/04/2021 -
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Human medicine European public assessment report (EPAR): Equidacent (updated)
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,,
, Revision: 2, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Elebrato Ellipta (updated)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017,, Revision: 8, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): MenQuadfi (updated)
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020,, Revision: 1, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Onglyza (updated)
Saxagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 30/09/2009, Revision: 19, Authorised, Last updated: 16/04/2021 -
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Human medicine European public assessment report (EPAR): Jinarc (updated)
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 15, Authorised, Last updated: 16/04/2021
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Human medicine European public assessment report (EPAR): DuoPlavin (updated)
clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 24, Authorised, Last updated: 16/04/2021 -
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,,
, Revision: 5, Authorised, Last updated: 16/04/2021