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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,
, Revision: 5, Authorised, Last updated: 08/03/2021
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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,
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, Revision: 3, Authorised, Last updated: 04/03/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021,, , Authorised, Last updated: 04/03/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 9, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, 
, Revision: 11, Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , 
, Revision: 18, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Epidyolex (updated)
Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 5, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 8, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Imbruvica (updated)
Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014,, Revision: 21, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Vpriv (updated)
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, , Revision: 14, Authorised, Last updated: 26/02/2021
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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: 11, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Prepandrix (updated)
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, , Revision: 11, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, , Revision: 9, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , , Revision: 11, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 20, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 20, Authorised, Last updated: 16/02/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 1, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 9, Authorised, Last updated: 08/02/2021
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Human medicine European public assessment report (EPAR): Empliciti
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, , Revision: 8, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 8, Authorised, Last updated: 01/02/2021
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Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute, Mastocytosis
Date of authorisation: 18/09/2017,, , Revision: 4, Authorised, Last updated: 01/02/2021
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Human medicine European public assessment report (EPAR): Bosulif
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013,, , Revision: 20, Authorised, Last updated: 29/01/2021