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719 results
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 25, Authorised, Last updated: 08/08/2022
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Human medicine European public assessment report (EPAR): Myclausen (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 07/10/2010,, Revision: 15, Authorised, Last updated: 04/08/2022
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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,,
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, Revision: 22, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma) (updated)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)
acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 02/08/2022
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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): 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): 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): 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): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,,
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, Revision: 4, 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): 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): Veklury (updated)
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,,
, Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,,
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, Revision: 11, Authorised, Last updated: 28/07/2022
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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,,
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, Revision: 26, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Amversio (updated)
betaine, Homocystinuria
Date of authorisation: 05/05/2022,,
, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,,
, Revision: 12, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously 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: 22, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Sandoz (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/09/2015,, Revision: 7, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Xenpozyme (updated)
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,,
, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 7, Authorised, Last updated: 27/07/2022