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389 results
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Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,
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, Revision: 5, Authorised, Last updated: 04/11/2020
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Human medicine European public assessment report (EPAR): NexoBrid
concentrate of proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, , Revision: 10, Authorised, Last updated: 03/11/2020
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Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, 
, , Revision: 10, Authorised, Last updated: 03/11/2020
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Human medicine European public assessment report (EPAR): Palynziq
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,, , Revision: 1, Authorised, Last updated: 30/10/2020
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Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,, 
, Revision: 6, Authorised, Last updated: 29/10/2020
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Human medicine European public assessment report (EPAR): Hetlioz
tasimelteon, Sleep Disorders, Circadian Rhythm
Date of authorisation: 03/07/2015,, Revision: 6, Authorised, Last updated: 29/10/2020
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Human medicine European public assessment report (EPAR): Bronchitol
mannitol, Cystic Fibrosis
Date of authorisation: 13/04/2012,, Revision: 15, Authorised, Last updated: 28/10/2020
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Human medicine European public assessment report (EPAR): Mozobil
Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma
Date of authorisation: 30/07/2009,, Revision: 19, Authorised, Last updated: 27/10/2020
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Human medicine European public assessment report (EPAR): SomaKit TOC
edotreotide, Neuroendocrine Tumors, Radionuclide Imaging
Date of authorisation: 08/12/2016,, , Revision: 6, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, 
, Revision: 17, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Cystadrops
mercaptamine hydrochloride, Cystinosis
Date of authorisation: 18/01/2017,, Revision: 7, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 05/07/2018,, , , Revision: 6, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde)
irinotecan hydrochloride trihydrate, Pancreatic Neoplasms
Date of authorisation: 14/10/2016,, Revision: 7, Authorised, Last updated: 15/10/2020
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Human medicine European public assessment report (EPAR): Mepsevii
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 5, Authorised, Last updated: 13/10/2020
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Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute, Mastocytosis
Date of authorisation: 18/09/2017,, , Revision: 3, Authorised, Last updated: 12/10/2020
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, Revision: 1, Authorised, Last updated: 07/10/2020
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Human medicine European public assessment report (EPAR): Tobi Podhaler
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 16, Authorised, Last updated: 01/10/2020
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Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 18, Authorised, Last updated: 29/09/2020
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 2, Authorised, Last updated: 29/09/2020
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 4, Authorised, Last updated: 25/09/2020
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Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 19, Authorised, Last updated: 23/09/2020
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , , Revision: 13, Authorised, Last updated: 21/09/2020
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Human medicine European public assessment report (EPAR): Epidyolex
Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 4, Authorised, Last updated: 18/09/2020
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,, Revision: 27, Authorised, Last updated: 16/09/2020
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Human medicine European public assessment report (EPAR): Imbruvica
Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014,, Revision: 20, Authorised, Last updated: 14/09/2020