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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,
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, Revision: 5, Authorised, Last updated: 18/12/2020
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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): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, 
, , Revision: 5, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, , Revision: 24, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , , Revision: 7, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,, , Revision: 20, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Silapo
epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic
Date of authorisation: 18/12/2007,, Revision: 17, Authorised, Last updated: 25/11/2020
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Human medicine European public assessment report (EPAR): Mvabea
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 3, Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Inflectra
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 26, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Semglee
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, , Revision: 5, Authorised, Last updated: 12/11/2020
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Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, , Revision: 6, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Pelmeg
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 4, Authorised, Last updated: 09/11/2020
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Human medicine European public assessment report (EPAR): Hyrimoz
adalimumab, Hidradenitis Suppurativa, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Skin Diseases, Papulosquamous, Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 7, Authorised, Last updated: 06/11/2020
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Human medicine European public assessment report (EPAR): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,, , Revision: 4, Authorised, Last updated: 28/10/2020
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, , Revision: 4, Authorised, Last updated: 27/10/2020
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Human medicine European public assessment report (EPAR): Ratiograstim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 12, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Grastofil
filgrastim, Neutropenia
Date of authorisation: 17/10/2013,, Revision: 13, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Mepsevii
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 5, Authorised, Last updated: 13/10/2020
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 6, Authorised, Last updated: 31/08/2020
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 11, Authorised, Last updated: 24/08/2020
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Human medicine European public assessment report (EPAR): Orphacol
cholic acid, Digestive System Diseases, Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 9, Authorised, Last updated: 11/08/2020
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 20, Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Fulphila
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 6, Authorised, Last updated: 18/05/2020
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Human medicine European public assessment report (EPAR): Grasustek
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, , Revision: 1, Authorised, Last updated: 31/03/2020