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Human medicine European public assessment report (EPAR): Spikevax (previously 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,
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, Revision: 10, Authorised, Last updated: 23/07/2021
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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,, , Revision: 10, Authorised, Last updated: 22/07/2021
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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: 5, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Imcivree (updated)
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,, 
, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, 
, Revision: 5, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 14, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Accofil (updated)
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 12, Authorised, Last updated: 22/07/2021
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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: 8, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Inflectra (updated)
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 27, Authorised, Last updated: 20/07/2021
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Human medicine European public assessment report (EPAR): Dacogen (updated)
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,, Revision: 16, Authorised, Last updated: 20/07/2021
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Human medicine European public assessment report (EPAR): Grasustek (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, , Revision: 2, Authorised, Last updated: 20/07/2021
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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: 10, Authorised, Last updated: 19/07/2021
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Human medicine European public assessment report (EPAR): Jemperli (updated)
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,, , Revision: 1, Authorised, Last updated: 16/07/2021
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Human medicine European public assessment report (EPAR): Mozobil (updated)
Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma
Date of authorisation: 30/07/2009,, Revision: 20, Authorised, Last updated: 14/07/2021
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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: 18, Authorised, Last updated: 14/07/2021
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Human medicine European public assessment report (EPAR): Hulio (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 17/09/2018,, , Revision: 7, Authorised, Last updated: 13/07/2021
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Human medicine European public assessment report (EPAR): Hetlioz (updated)
tasimelteon, Sleep Disorders, Circadian Rhythm
Date of authorisation: 03/07/2015,, Revision: 7, Authorised, Last updated: 13/07/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 14, Authorised, Last updated: 13/07/2021
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Human medicine European public assessment report (EPAR): Sirturo (updated)
bedaquiline fumarate, Tuberculosis, Multidrug-Resistant
Date of authorisation: 05/03/2014,, , , Revision: 18, Authorised, Last updated: 13/07/2021
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Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 4, Authorised, Last updated: 09/07/2021
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Human medicine European public assessment report (EPAR): Yescarta (updated)
axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 7, Authorised, Last updated: 08/07/2021
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 9, Authorised, Last updated: 08/07/2021
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, , Revision: 5, Authorised, Last updated: 08/07/2021
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Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) (updated)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,, , Revision: 8, Authorised, Last updated: 08/07/2021
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Human medicine European public assessment report (EPAR): Besponsa (updated)
inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,, , Revision: 8, Authorised, Last updated: 08/07/2021