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664 results
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Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,
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, Revision: 26, Authorised, Last updated: 07/08/2020
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Human medicine European public assessment report (EPAR): Darunavir Krka (updated)
darunavir, HIV Infections
Date of authorisation: 26/01/2018,
, Revision: 5, Authorised, Last updated: 07/08/2020
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 3, Authorised, Last updated: 07/08/2020
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/xxxxx (H3N2)-like strain (reassortant used)/ A/xxxxx H1N1- like strain (reassortant used)/ B/xxxxx (Yamagata Lineage) – like strain (reassortant used)/ B/xxxxx (Victoria Lineage) – like strain (reassortant used), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 5, Authorised, Last updated: 06/08/2020
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Human medicine European public assessment report (EPAR): Capecitabine Medac (updated)
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,
, , Revision: 10, Authorised, Last updated: 05/08/2020
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 6, Authorised, Last updated: 04/08/2020
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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: 8, Authorised, Last updated: 03/08/2020
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Human medicine European public assessment report (EPAR): Capecitabine Accord (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 12, Authorised, Last updated: 03/08/2020
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Human medicine European public assessment report (EPAR): Kisqali (updated)
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017,, Revision: 6, Authorised, Last updated: 03/08/2020
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Human medicine European public assessment report (EPAR): Shingrix (updated)
Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster
Date of authorisation: 21/03/2018,, Revision: 4, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Olazax (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 11/12/2009,, Revision: 12, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Zurampic (updated)
lesinurad, Hyperuricemia
Date of authorisation: 18/02/2016,, Revision: 4, Withdrawn, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 1, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Tagrisso (updated)
osimertinib mesylate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, 
, Revision: 11, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Translarna (updated)
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 17, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Picato (updated)
Ingenol mebutate, Keratosis, Actinic
Date of authorisation: 15/11/2012,, , Revision: 10, Withdrawn, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 12, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS) (updated)
nitisinone, Tyrosinemias
Date of authorisation: 24/08/2017,, Revision: 4, Authorised, Last updated: 30/07/2020
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Human medicine European public assessment report (EPAR): Capecitabine Teva (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,, , Revision: 13, Authorised, Last updated: 29/07/2020
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 22, Authorised, Last updated: 29/07/2020
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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: 21, Authorised, Last updated: 29/07/2020
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , , Revision: 17, Authorised, Last updated: 29/07/2020
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Human medicine European public assessment report (EPAR): Ajovy (updated)
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 3, Authorised, Last updated: 29/07/2020
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosylate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 9, Authorised, Last updated: 28/07/2020
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Human medicine European public assessment report (EPAR): Fetcroja (updated)
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 1, Authorised, Last updated: 28/07/2020