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Medicine
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Human medicine European public assessment report (EPAR): Tacforius (updated)
tacrolimus monohydrate, Liver Transplantation; Kidney Transplantation
Date of authorisation: 08/12/2017,
, Revision: 7, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 8, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 15, Authorised, Last updated: 09/01/2023
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,
, Revision: 18, Authorised, Last updated: 06/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 14, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 15, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Mvasi (updated)
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: 14, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Ibandronic acid Accord (updated)
ibandronic acid, Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
Date of authorisation: 18/11/2012,, Revision: 14, Authorised, Last updated: 05/01/2023
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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: 3, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Byooviz (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, , Revision: 5, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 12, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Oyavas (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: 26/03/2021,, , Revision: 4, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Posaconazole AHCL
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 5, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Teva
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 12/12/2022,, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Olanzapine Glenmark Europe
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 03/12/2009,, Revision: 14, Authorised, Last updated: 20/12/2022
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Human medicine European public assessment report (EPAR): Olanzapine Glenmark
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 03/12/2009,, Revision: 15, Authorised, Last updated: 20/12/2022
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Human medicine European public assessment report (EPAR): Bemfola
follitropin alfa, Anovulation
Date of authorisation: 26/03/2014,, Revision: 10, Authorised, Last updated: 19/12/2022
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 7, Authorised, Last updated: 19/12/2022
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 6, Authorised, Last updated: 15/12/2022
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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: 4, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Aybintio
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: 6, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Abevmy
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: 21/04/2021,, , Revision: 5, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Nityr
nitisinone, Tyrosinemias
Date of authorisation: 26/07/2018,, Revision: 3, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Retacrit
epoetin zeta, Anemia; Blood Transfusion, Autologous; Kidney Failure, Chronic; Cancer
Date of authorisation: 18/12/2007,, Revision: 30, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Imatinib Accord
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 20, Authorised, Last updated: 14/12/2022