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229 results
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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,
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, Revision: 23, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 10, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,
, Revision: 22, Authorised, Last updated: 09/10/2019
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Human medicine European public assessment report (EPAR): Epysqli (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023,, , Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, , Revision: 3, Withdrawn, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): Erelzi
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, , Revision: 12, Authorised, Last updated: 09/09/2022
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Human medicine European public assessment report (EPAR): Filgrastim Hexal
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 21, Authorised, Last updated: 10/02/2023
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Human medicine European public assessment report (EPAR): Filgrastim ratiopharm
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 1, Withdrawn, Last updated: 20/07/2011
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Human medicine European public assessment report (EPAR): Flixabi
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid; Crohn Disease; Psoriasis
Date of authorisation: 26/05/2016,, Revision: 23, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Fulphila
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 10, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Gavreto
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,, , Revision: 3, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Grastofil
filgrastim, Neutropenia
Date of authorisation: 17/10/2013,, Revision: 14, Authorised, Last updated: 10/01/2022
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Human medicine European public assessment report (EPAR): Grasustek
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, , Revision: 4, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, Revision: 12, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hemgenix
Etranacogene dezaparvovec, Hemophilia B
Date of authorisation: 20/02/2023,, , , Revision: 1, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , , Revision: 9, Authorised, Last updated: 04/04/2023
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, Revision: 19, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Holoclar
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 8, Authorised, Last updated: 06/01/2022
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Human medicine European public assessment report (EPAR): Hukyndra
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021,, Revision: 4, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Hulio
adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic
Date of authorisation: 17/09/2018,, , Revision: 13, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Humenza
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 08/06/2010,, Withdrawn, Last updated: 30/06/2011
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Human medicine European public assessment report (EPAR): Hyrimoz
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, Revision: 11, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Idacio
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 02/04/2019,, , Revision: 10, Authorised, Last updated: 18/10/2022