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Human medicine European public assessment report (EPAR): Bortezomib Accord (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,
, Revision: 8, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 15, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Entecavir Accord (updated)
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 3, Authorised, Last updated: 29/01/2021
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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: 8, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Hospira (updated)
levetiracetam, Epilepsy
Date of authorisation: 07/01/2014,, Revision: 16, Authorised, Last updated: 28/01/2021
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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: 2, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Telmisartan Teva Pharma (updated)
telmisartan, Hypertension
Date of authorisation: 03/10/2011,, Revision: 9, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 8, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Darunavir Krka (updated)
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 6, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Ibandronic Acid Teva (updated)
ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, Osteoporosis, Postmenopausal
Date of authorisation: 17/09/2010,, Revision: 10, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)
acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 2, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)
telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 12, Authorised, Last updated: 27/01/2021
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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: 12, Authorised, Last updated: 18/01/2021
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 3, Authorised, Last updated: 18/01/2021
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,, Revision: 8, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Grepid
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 27/07/2009,, Revision: 21, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Krka
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 15, Authorised, Last updated: 13/01/2021
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Human medicine European public assessment report (EPAR): Daptomycin Hospira
daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 22/03/2017,, Revision: 9, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Telmisartan Actavis
telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 10, Authorised, Last updated: 05/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 15, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Mylan
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 16, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Marixino (previously Maruxa)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 28/04/2013,, Revision: 7, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Pramipexole Accord
pramipexole dihydrochloride monohydrate, Parkinson Disease, Restless Legs Syndrome
Date of authorisation: 29/09/2011,, Revision: 10, Authorised, Last updated: 11/12/2020
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Human medicine European public assessment report (EPAR): Vizarsin
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 15, Authorised, Last updated: 10/12/2020