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656 results
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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,
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, Revision: 5, 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): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, 
, , Revision: 2, 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): 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): 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
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Authorised, Last updated: 16/04/2021
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Human medicine European public assessment report (EPAR): Oncaspar (updated)
pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016,, Revision: 13, Authorised, Last updated: 15/04/2021
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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: 3, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,
, Revision: 9, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): Fotivda (updated)
tivozanib, Carcinoma, Renal Cell
Date of authorisation: 24/08/2017,, Revision: 5, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): Azacitidine Accord (updated)
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 1, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): Rukobia (updated)
fostemsavir trometamol, HIV Infections
Date of authorisation: 04/02/2021,, Revision: 1, Authorised, Last updated: 13/04/2021
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)
deferasirox, Iron Overload, beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 4, Authorised, Last updated: 13/04/2021
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Human medicine European public assessment report (EPAR): Erleada (updated)
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 3, Authorised, Last updated: 12/04/2021
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 9, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan (updated)
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 11, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,, 
, , Revision: 7, Authorised, Last updated: 09/04/2021
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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,, , , Revision: 3, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Ogivri (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 6, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 6, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Olanzapine Teva (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 28, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , 
, Revision: 5, Authorised, Last updated: 08/04/2021