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591 results
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Human medicine European public assessment report (EPAR): Opsumit (updated)
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,
, Revision: 18, Authorised, Last updated: 18/06/2021
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Human medicine European public assessment report (EPAR): Palynziq (updated)
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,
, , Revision: 2, Authorised, Last updated: 17/06/2021
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Veterinary medicine European public assessment report (EPAR): Emdocam (updated)
meloxicam, Horses, Pigs, Cattle
Date of authorisation: 18/08/2011,
, Revision: 8, Authorised, Last updated: 16/06/2021
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Human medicine European public assessment report (EPAR): Vimizim (updated)
recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014,, , Revision: 12, Authorised, Last updated: 16/06/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 13, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 13, Authorised, Last updated: 11/06/2021
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Veterinary medicine European public assessment report (EPAR): Tulissin (updated)
tulathromycin, Cattle, Pigs, Sheep
Date of authorisation: 24/04/2020,, Revision: 2, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm (updated)
clopidogrel (as hydrogen sulfate), Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke
Date of authorisation: 18/02/2015,, Revision: 11, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , 
, Revision: 22, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Zalasta (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 27/09/2007,, Revision: 18, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 17, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira) (updated)
voriconazole, Bacterial Infections and Mycoses, Aspergillosis, Candidiasis
Date of authorisation: 27/05/2015,, Revision: 9, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 11, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Inrebic (updated)
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders, Primary Myelofibrosis
Date of authorisation: 08/02/2021,, , Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, 
, , Revision: 10, Authorised, Last updated: 07/06/2021
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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: 14, Authorised, Last updated: 04/06/2021
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Human medicine European public assessment report (EPAR): Dacogen (updated)
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,, Revision: 15, Authorised, Last updated: 04/06/2021
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Human medicine European public assessment report (EPAR): Polivy (updated)
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, , , Revision: 3, Authorised, Last updated: 04/06/2021
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,, Revision: 11, Authorised, Last updated: 04/06/2021
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Human medicine European public assessment report (EPAR): Xospata (updated)
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,, , Revision: 1, Authorised, Last updated: 03/06/2021
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Human medicine European public assessment report (EPAR): Nityr (updated)
nitisinone, Tyrosinemias
Date of authorisation: 26/07/2018,, Revision: 2, Authorised, Last updated: 03/06/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 7, Authorised, Last updated: 02/06/2021
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Human medicine European public assessment report (EPAR): Ledaga (updated)
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 7, Authorised, Last updated: 01/06/2021
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Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 24/06/2015,, Revision: 9, Authorised, Last updated: 31/05/2021
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Human medicine European public assessment report (EPAR): Xermelo (updated)
telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors
Date of authorisation: 17/09/2017,, , Revision: 12, Authorised, Last updated: 31/05/2021