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383 results
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Human medicine European public assessment report (EPAR): Hyftor (updated)
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 (updated)
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 (updated)
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,
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, Revision: 13, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, 
, Revision: 3, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 12, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
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 (updated)
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 (updated)
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): Retsevmo (updated)
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,, , Revision: 8, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Talvey (updated)
talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023,, , , Authorised, Last updated: 21/09/2023
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Human medicine European public assessment report (EPAR): Strimvelis (updated)
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) (updated)
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 (updated)
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): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 8, Withdrawn, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Roctavian (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
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): Voxzogo (updated)
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,, , Revision: 3, Authorised, Last updated: 06/09/2023
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 16, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Fintepla (updated)
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 6, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)
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): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , , Revision: 12, Authorised, Last updated: 29/08/2023