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78 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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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: 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,,
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, Revision: 27, 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,,
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, Authorised, Last updated: 21/09/2023
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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,,
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, 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,,
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, Revision: 7, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Roctavian (updated)
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,,
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, 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,,
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, Revision: 6, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,,
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, Revision: 16, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,,
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, Revision: 16, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Zolgensma
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 12, Authorised, Last updated: 29/08/2023
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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: 6, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,,
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, Revision: 5, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, Revision: 52, Authorised, Last updated: 16/08/2023
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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,,
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, Revision: 25, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Zabdeno
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,,
, Revision: 4, Authorised, Last updated: 14/08/2023
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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,,
, Revision: 3, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,,
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, Revision: 4, Authorised, Last updated: 01/08/2023
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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,,
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, Revision: 6, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Tecvayli
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,,
, Revision: 1, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
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, Revision: 4, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,,
, Revision: 7, Authorised, Last updated: 18/07/2023