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182 results
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Human medicine European public assessment report (EPAR): Ravicti (updated)
glycerol phenylbutyrate, Urea Cycle Disorders, Inborn
Date of authorisation: 26/11/2015,
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, Revision: 14, Authorised, Last updated: 21/01/2022
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , 
, Revision: 12, Authorised, Last updated: 21/01/2022
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Human medicine European public assessment report (EPAR): Zynteglo (updated)
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, 
, , , Revision: 5, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Revision: 16, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 19, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Voraxaze (updated)
glucarpidase, Metabolic Side Effects of Drugs and Substances
Date of authorisation: 11/01/2022,, , 
, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 7, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, , Revision: 1, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, , , Revision: 9, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, , Revision: 18, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, , Revision: 17, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Zytiga (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 23, Authorised, Last updated: 17/01/2022
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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: 2, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,, Revision: 13, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane) (updated)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,, Revision: 9, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Revision: 3, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Artesunate Amivas (updated)
artesunate, Malaria
Date of authorisation: 22/11/2021,, , Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Scenesse (updated)
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , , Revision: 8, Authorised, Last updated: 12/01/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, , Revision: 17, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Minjuvi (updated)
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,, , , Revision: 2, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 18, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Cerdelga (updated)
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 13, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 10, Authorised, Last updated: 10/01/2022
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)
Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013,, , Revision: 21, Authorised, Last updated: 10/01/2022
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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,, , Authorised, Last updated: 07/01/2022