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Medicine
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Human medicine European public assessment report (EPAR): Omnitrope (updated)
somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
Date of authorisation: 12/04/2006,
, Revision: 21, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Filsuvez (updated)
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,
, Revision: 1, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 15, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Amgevita (updated)
adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,, Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 15, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 31, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,
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, Revision: 1, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Livtencity (updated)
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,, , Revision: 1, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , 
, Revision: 23, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Koselugo (updated)
Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021,, , , Revision: 4, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 11, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Idefirix (updated)
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,, , , Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Hukyndra (updated)
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: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 12, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Nivestim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010,, Revision: 26, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Ebvallo (updated)
Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022,, , , Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Alofisel (updated)
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 9, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Libmyris (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021,, Revision: 1, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 13, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 7, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Amvuttra (updated)
vutrisiran sodium, Amyloid Neuropathies, Familial
Date of authorisation: 15/09/2022,, , Revision: 1, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Adakveo (updated)
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , , Revision: 3, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Pemazyre
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 4, Authorised, Last updated: 09/01/2023
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Human medicine European public assessment report (EPAR): Benepali
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,, Revision: 18, Authorised, Last updated: 06/01/2023