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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 Orphan designations Remove Orphan designations filter

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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)

daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018, , Revision: 4, Authorised, Last updated: 27/01/2021
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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: 6, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Lojuxta (updated)

Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013, , , Revision: 13, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Lutathera (updated)

lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017, , , Revision: 4, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , , Revision: 15, Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021, , , Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): Takhzyro (updated)

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , , Revision: 4, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 8, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)

nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015, , Revision: 17, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Symkevi (updated)

tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018, , , Revision: 7, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 11, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Kalydeco (updated)

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , , Revision: 27, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Wakix (updated)

pitolisant, Narcolepsy
Date of authorisation: 31/03/2016, , , Revision: 9, Authorised, Last updated: 21/01/2021
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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): 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
List item

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): 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