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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Referrals Remove Referrals filter

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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): 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: 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
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Human medicine European public assessment report (EPAR): Kymriah (updated)

tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018, , , Revision: 4, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Libtayo (updated)

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 6, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Senshio (updated)

ospemifene, Postmenopause
Date of authorisation: 14/01/2015, , Revision: 11, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Vaxchora (updated)

vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020, , Revision: 2, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Kisplyx (updated)

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , , Revision: 13, Authorised, Last updated: 07/04/2021