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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015, , , Revision: 14, Authorised, Last updated: 15/01/2021
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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: 12, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Mayzent (updated)

Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020, , Revision: 4, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Holoclar (updated)

ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases
Date of authorisation: 17/02/2015, , , , Revision: 7, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Foclivia (updated)

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009, , Revision: 10, Authorised, Last updated: 13/01/2021
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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: 1, Authorised, Last updated: 12/01/2021
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Human medicine European public assessment report (EPAR): Ocrevus (updated)

ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, , Revision: 8, Authorised, Last updated: 11/01/2021
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Human medicine European public assessment report (EPAR): Axumin (updated)

Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging
Date of authorisation: 21/05/2017, , Revision: 10, Authorised, Last updated: 11/01/2021
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Human medicine European public assessment report (EPAR): Ozempic (updated)

semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018, , Revision: 4, Authorised, Last updated: 11/01/2021
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Human medicine European public assessment report (EPAR): Daurismo (updated)

Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020, , , Revision: 1, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Roteas (updated)

edoxaban tosylate, Stroke, Venous Thromboembolism
Date of authorisation: 19/04/2017, , Revision: 7, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 8, Authorised, Last updated: 08/01/2021
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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: 9, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Livogiva (updated)

teriparatide, Osteoporosis
Date of authorisation: 27/08/2020, , , Revision: 1, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Zirabev (updated)

bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019, , , Revision: 7, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Luxturna (updated)

voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa
Date of authorisation: 22/11/2018, , , Revision: 3, Authorised, Last updated: 05/01/2021
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Human medicine European public assessment report (EPAR): Erelzi (updated)

etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Date of authorisation: 23/06/2017, , , Revision: 8, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)

nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015, , Revision: 16, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Rinvoq (updated)

Upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , Revision: 2, Authorised, Last updated: 04/01/2021
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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: 7, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Taltz (updated)

ixekizumab, Psoriasis
Date of authorisation: 25/04/2016, , Revision: 11, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Alofisel (updated)

darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018, , , Revision: 6, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , , Revision: 4, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Hemlibra (updated)

Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018, , , Revision: 7, Authorised, Last updated: 22/12/2020