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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,
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, Revision: 2, Authorised, Last updated: 12/05/2021
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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: 6, Authorised, Last updated: 12/05/2021
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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: 6, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 3, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, 
, Revision: 3, Authorised, Last updated: 12/05/2021
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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: 16, Authorised, Last updated: 11/05/2021
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Human medicine European public assessment report (EPAR): Ruxience (updated)
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell, Arthritis, Rheumatoid, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 3, Authorised, Last updated: 11/05/2021
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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,, , Revision: 2, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,, , Revision: 17, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Translarna (updated)
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 19, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 18, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Aybintio (updated)
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,, , Revision: 3, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,, Revision: 2, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 10, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Nivestim (updated)
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 07/06/2010,, Revision: 23, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Lorviqua (updated)
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 5, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Omnitrope (updated)
somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006,, Revision: 18, Authorised, Last updated: 28/04/2021
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Human medicine European public assessment report (EPAR): Hefiya (updated)
adalimumab, Hidradenitis Suppurativa, Spondylitis, Ankylosing, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis
Date of authorisation: 26/07/2018,, , Revision: 7, Authorised, Last updated: 28/04/2021
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Human medicine European public assessment report (EPAR): Retacrit (updated)
epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer
Date of authorisation: 18/12/2007,, Revision: 28, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Tevagrastim (updated)
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 14, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 9, Authorised, Last updated: 23/04/2021
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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: 7, Authorised, Last updated: 23/04/2021
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, , Revision: 9, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): Movymia (updated)
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, , Revision: 8, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, Revision: 14, Authorised, Last updated: 22/04/2021