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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): 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
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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): 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): 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): Mylotarg (updated)

gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018, , , Revision: 7, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Adcetris

Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012, , , , Revision: 28, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Idacio

adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease
Date of authorisation: 02/04/2019, , , Revision: 5, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene)

Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013, , , Revision: 17, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Isturisa

Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020, , , Revision: 3, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Deltyba

Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013, , , , Revision: 14, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Kalydeco

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , , Revision: 26, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Ocaliva

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 7, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Ledaga

Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017, , Revision: 5, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Polivy

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 2, Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Imvanex

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013, , , Revision: 18, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria)

insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014, , Revision: 10, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Myalepta

Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018, , , , Revision: 5, Authorised, Last updated: 10/12/2020