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Medicine
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,,
, Revision: 18, Authorised, Last updated: 01/04/2022
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Human medicine European public assessment report (EPAR): Adcetris
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,,
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, Revision: 32, Authorised, Last updated: 31/03/2022
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Human medicine European public assessment report (EPAR): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,,
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, Revision: 13, Authorised, Last updated: 31/03/2022
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,,
, Revision: 10, Authorised, Last updated: 28/03/2022
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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: 20, Authorised, Last updated: 25/03/2022
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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: 1, Authorised, Last updated: 24/03/2022
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,,
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, Revision: 10, Authorised, Last updated: 18/03/2022
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Human medicine European public assessment report (EPAR): Retsevmo
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,,
, Revision: 3, Authorised, Last updated: 14/03/2022
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Human medicine European public assessment report (EPAR): Pemazyre
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,,
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, Revision: 2, Authorised, Last updated: 02/03/2022
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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,,
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, Revision: 5, Authorised, Last updated: 23/02/2022
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,,
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, Revision: 7, Authorised, Last updated: 16/02/2022
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Human medicine European public assessment report (EPAR): Empliciti
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,,
, Revision: 9, Authorised, Last updated: 16/02/2022
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Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,,
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, Revision: 21, Authorised, Last updated: 10/02/2022
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,,
, Revision: 5, Authorised, Last updated: 09/02/2022
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Human medicine European public assessment report (EPAR): Rybrevant
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,,
, Authorised, Last updated: 04/02/2022
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,,
, Revision: 11, Authorised, Last updated: 04/02/2022
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Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,,
, Revision: 4, Authorised, Last updated: 04/02/2022
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Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,,
, Revision: 13, Authorised, Last updated: 02/02/2022
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,,
, Revision: 21, Authorised, Last updated: 28/01/2022
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,,
, Revision: 24, Authorised, Last updated: 25/01/2022
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Human medicine European public assessment report (EPAR): Verkazia
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,,
, Revision: 6, Authorised, Last updated: 25/01/2022
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,,
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, Revision: 12, Authorised, Last updated: 21/01/2022
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,,
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, Revision: 5, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,,
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, Revision: 7, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Evrysdi
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,,
, Revision: 1, Authorised, Last updated: 19/01/2022