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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,
, Revision: 14, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Entecavir Mylan
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 6, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 4, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Granpidam
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 8, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Dapagliflozin Viatris
dapagliflozin, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 24/03/2023,, Authorised, Last updated: 04/04/2023
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, Revision: 13, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Withdrawn, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Withdrawn, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Memantine Mylan
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 10, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Revision: 4, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Deferasirox Mylan
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 9, Authorised, Last updated: 28/03/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 15, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Miglustat Dipharma
miglustat, Gaucher Disease
Date of authorisation: 18/02/2019,, Revision: 5, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 16, Withdrawn, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Docetaxel Accord
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 16, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 13, Withdrawn, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Miglustat Gen.Orph
miglustat, Gaucher Disease
Date of authorisation: 09/11/2017,, Revision: 9, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Abiraterone Mylan
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Ivozall
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019,, Revision: 4, Authorised, Last updated: 13/03/2023
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Human medicine European public assessment report (EPAR): Nityr
nitisinone, Tyrosinemias
Date of authorisation: 26/07/2018,, Revision: 4, Authorised, Last updated: 10/03/2023
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Human medicine European public assessment report (EPAR): Leflunomide medac
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 18, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Olanzapine Apotex
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 10/06/2010,, Revision: 13, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Abiraterone Krka
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023