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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, , , Revision: 1, Authorised, Last updated: 21/04/2021
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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): Cabometyx (updated)

cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016, , , Revision: 10, 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): 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): 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): 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): 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): 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): 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): 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): 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): Opsumit (updated)

Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013, , Revision: 17, 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): Brineura (updated)

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 5, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Doptelet (updated)

avatrombopag maleate, Thrombocytopenia
Date of authorisation: 20/06/2019, , Revision: 4, Authorised, Last updated: 07/04/2021