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Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Nexpovio (updated)
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,
, Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Xofluza (updated)
Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021,, Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Fluenz Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human
Date of authorisation: 04/12/2013, Revision: 22, Authorised, Last updated: 01/08/2022 -
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Human medicine European public assessment report (EPAR): Posaconazole AHCL (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,
, Revision: 4, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, 
, Revision: 6, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 11, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Okedi (updated)
Risperidone, Schizophrenia
Date of authorisation: 14/02/2022, Revision: 1, Authorised, Last updated: 01/08/2022 -
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Human medicine European public assessment report (EPAR): Strimvelis (updated)
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,, 
, Revision: 8, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Renvela (updated)
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 09/06/2009, Revision: 24, Authorised, Last updated: 01/08/2022 -
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Human medicine European public assessment report (EPAR): Bydureon (updated)
exenatide, Diabetes Mellitus, Type 2
Date of authorisation: 17/06/2011, Revision: 22, Authorised, Last updated: 01/08/2022 -
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Human medicine European public assessment report (EPAR): Vosevi (updated)
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, Revision: 13, Authorised, Last updated: 01/08/2022 -
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Human medicine European public assessment report (EPAR): Sogroya (updated)
Somapacitan, Growth
Date of authorisation: 31/03/2021,, , Revision: 1, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Rixubis (updated)
nonacog gamma, Hemophilia B
Date of authorisation: 19/12/2014, Revision: 10, Authorised, Last updated: 29/07/2022 -
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , 
, Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Zubsolv (updated)
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 8, Authorised, Last updated: 29/07/2022 -
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Entecavir Accord (updated)
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 14, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Vaborem (updated)
meropenem trihydrate, vaborbactam, Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated
Date of authorisation: 20/11/2018,, Revision: 6, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Regkirona (updated)
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Xydalba (updated)
dalbavancin hydrochloride, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 19/02/2015, Revision: 14, Authorised, Last updated: 29/07/2022 -
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Human medicine European public assessment report (EPAR): Tigecycline Accord (updated)
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Yuflyma (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021,
, Revision: 8, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Sarclisa (updated)
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Revision: 5, Authorised, Last updated: 28/07/2022