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443 results
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,
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, Revision: 5, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Sugammadex Fresenius Kabi (updated)
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/07/2022,
, Authorised, Last updated: 21/07/2022
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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: 5, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Sitagliptin Accord (updated)
sitagliptin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 25/04/2022,, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Onbevzi (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: 11/01/2021,, , Revision: 2, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 2, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 1, Authorised, Last updated: 20/07/2022
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Human medicine European public assessment report (EPAR): Ganirelix Gedeon Richter (updated)
ganirelix acetate, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 15/07/2022,, Authorised, Last updated: 20/07/2022
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Human medicine European public assessment report (EPAR): Azacitidine Accord (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 5, Authorised, Last updated: 19/07/2022
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Human medicine European public assessment report (EPAR): Potactasol (updated)
topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 06/01/2011,, Revision: 10, Authorised, Last updated: 18/07/2022
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Human medicine European public assessment report (EPAR): Filgrastim Hexal
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 18, Authorised, Last updated: 15/07/2022
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Human medicine European public assessment report (EPAR): Zarzio
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 19, Authorised, Last updated: 15/07/2022
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Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 8, Authorised, Last updated: 15/07/2022
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Human medicine European public assessment report (EPAR): Mvasi
bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018,, , Revision: 12, Authorised, Last updated: 14/07/2022
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Human medicine European public assessment report (EPAR): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, 
, Revision: 31, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Blitzima
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, Revision: 15, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 15, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Clopidogrel TAD
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 15, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Nemdatine
memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013,, Revision: 11, Authorised, Last updated: 07/07/2022
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Human medicine European public assessment report (EPAR): Abiraterone Krka
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 1, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 19, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 9, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 3, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Ucedane
carglumic acid, Hyperammonemia; Amino Acid Metabolism, Inborn Errors
Date of authorisation: 23/06/2017,, Revision: 11, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Oyavas
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: 26/03/2021,, , Revision: 3, Authorised, Last updated: 05/07/2022