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743 results
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Human medicine European public assessment report (EPAR): Dectova (updated)
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,
, Revision: 4, Authorised, Last updated: 08/10/2021
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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: 13, Authorised, Last updated: 08/10/2021
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Human medicine European public assessment report (EPAR): Intuniv (updated)
guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity
Date of authorisation: 17/09/2015,, Revision: 8, Authorised, Last updated: 07/10/2021
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Human medicine European public assessment report (EPAR): Zydelig (updated)
Idelalisib, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 18/09/2014,, Revision: 19, Authorised, Last updated: 06/10/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, 
, , Revision: 23, Authorised, Last updated: 06/10/2021
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Human medicine European public assessment report (EPAR): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, , Revision: 9, Authorised, Last updated: 06/10/2021
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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: 9, Authorised, Last updated: 05/10/2021
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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: 1, Authorised, Last updated: 05/10/2021
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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,, , Revision: 12, Authorised, Last updated: 05/10/2021
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Human medicine European public assessment report (EPAR): Adynovi (updated)
rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018,, Revision: 5, Authorised, Last updated: 04/10/2021
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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: 4, Authorised, Last updated: 04/10/2021
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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: 13, Authorised, Last updated: 29/09/2021
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Human medicine European public assessment report (EPAR): Sunosi (updated)
solriamfetol hydrochloride, Narcolepsy; Sleep Apnea, Obstructive
Date of authorisation: 16/01/2020,, Revision: 2, Authorised, Last updated: 27/09/2021
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Human medicine European public assessment report (EPAR): Hepcludex (updated)
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , , Revision: 4, Authorised, Last updated: 24/09/2021
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Human medicine European public assessment report (EPAR): Harvoni (updated)
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, , Revision: 23, Authorised, Last updated: 23/09/2021
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Human medicine European public assessment report (EPAR): Glyxambi (updated)
empagliflozin, linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2016,, Revision: 12, Authorised, Last updated: 23/09/2021
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, , Revision: 8, Authorised, Last updated: 23/09/2021
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, , Revision: 7, Authorised, Last updated: 21/09/2021
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Human medicine European public assessment report (EPAR): Riximyo (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,, 
, Revision: 6, Authorised, Last updated: 21/09/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 7, Authorised, Last updated: 20/09/2021
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, , Revision: 11, Authorised, Last updated: 15/09/2021
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Human medicine European public assessment report (EPAR): Imvanex (updated)
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013,, 
, Revision: 19, Authorised, Last updated: 15/09/2021
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Urologic Neoplasms; Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,, Revision: 37, Authorised, Last updated: 15/09/2021
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Human medicine European public assessment report (EPAR): Elaprase (updated)
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 21, Authorised, Last updated: 15/09/2021
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Human medicine European public assessment report (EPAR): Lemtrada (updated)
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,
, , Revision: 15, Authorised, Last updated: 15/09/2021