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509 results
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Human medicine European public assessment report (EPAR): Aybintio (updated)
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,,
, Revision: 2, Authorised, Last updated: 06/04/2021
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Human medicine European public assessment report (EPAR): Ivozall (updated)
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019,, Revision: 2, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Teva (updated)
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 17, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Matever (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 22, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Pioglitazone Teva Pharma (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 12, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Mylan (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Revision: 1, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Hulio (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 16/09/2018,,
, Revision: 5, Authorised, Last updated: 30/03/2021
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Human medicine European public assessment report (EPAR): 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: 1, Authorised, Last updated: 30/03/2021
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Human medicine European public assessment report (EPAR): Trazimera (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018,,
, Revision: 7, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,,
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, Revision: 21, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Telmisartan Teva (updated)
telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira (updated)
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,, Revision: 17, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Strensiq (updated)
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,,
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, Revision: 14, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Deferiprone Lipomed (updated)
Deferiprone, Iron Overload, beta-Thalassemia
Date of authorisation: 19/09/2018,, Revision: 3, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 4, Authorised, Last updated: 24/03/2021
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Human medicine European public assessment report (EPAR): Bortezomib Hospira (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 10, Authorised, Last updated: 24/03/2021
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Human medicine European public assessment report (EPAR): Bortezomib Accord (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 9, Authorised, Last updated: 24/03/2021
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Veterinary medicine European public assessment report (EPAR): Acticam (updated)
meloxicam, Dogs, Cats
Date of authorisation: 09/12/2008,, Revision: 9, Withdrawn, Last updated: 24/03/2021
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Veterinary medicine European public assessment report (EPAR): Kriptazen (updated)
halofuginone, Calves, newborn
Date of authorisation: 08/02/2019,, Revision: 1, Authorised, Last updated: 24/03/2021
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 2, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Omnitrope
somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006,, Revision: 17, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,,
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, Revision: 15, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Olanzapine Mylan
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 16, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Nyvepria
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,,
, Revision: 1, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 11, Authorised, Last updated: 22/03/2021