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Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 18/10/2009,
, Revision: 13, Authorised, Last updated: 03/10/2023
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Human medicine European public assessment report (EPAR): SomaKit TOC
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,
, Revision: 15, Authorised, Last updated: 29/09/2023
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,
, , Revision: 11, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Trepulmix
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 4, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Hyftor
Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023,, Revision: 2, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 7, Authorised, Last updated: 25/09/2023
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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: 13, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , , Revision: 27, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Scemblix
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,, , Revision: 3, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Strimvelis
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,, , Revision: 9, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,, , , Revision: 6, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Mepsevii
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 7, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , 
, Revision: 3, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Pemazyre
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 6, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Ledaga
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 9, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Natpar
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 16, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Poteligeo
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, Revision: 6, Authorised, Last updated: 06/09/2023
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Human medicine European public assessment report (EPAR): Qinlock
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,, , Revision: 5, Authorised, Last updated: 30/08/2023
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Human medicine European public assessment report (EPAR): Enjaymo
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,, , Revision: 3, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Cerdelga
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 16, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, 
, , Revision: 10, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , , Revision: 5, Authorised, Last updated: 21/08/2023
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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: 25, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Revision: 2, Authorised, Last updated: 04/08/2023