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304 results
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Human medicine European public assessment report (EPAR): Levetiracetam Hospira (updated)
levetiracetam, Epilepsy
Date of authorisation: 07/01/2014,
, Revision: 15, Authorised, Last updated: 03/12/2020
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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: 3, Authorised, Last updated: 02/12/2020
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,, Revision: 5, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Enyglid (updated)
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2009,, Revision: 7, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Pemetrexed Krka (updated)
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 3, Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 7, Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma) (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 19, Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Granpidam (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 4, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (updated)
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 5, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 13, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 11, Authorised, Last updated: 25/11/2020
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Human medicine European public assessment report (EPAR): Posaconazole Accord (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 1, Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Docetaxel Teva (updated)
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/01/2010,, Revision: 18, Authorised, Last updated: 23/11/2020
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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: 11, Authorised, Last updated: 23/11/2020
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Human medicine European public assessment report (EPAR): Ribavirin Teva (updated)
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009,, Revision: 14, Authorised, Last updated: 23/11/2020
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Human medicine European public assessment report (EPAR): Ribavirin Mylan (previously Ribavirin Three Rivers) (updated)
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 10/06/2010,, Revision: 10, Withdrawn, Last updated: 23/11/2020
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Human medicine European public assessment report (EPAR): Zoledronic acid medac (updated)
zoledronic acid monohydrate, Fractures, Bone, Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,, Revision: 10, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Duloxetine Mylan (updated)
duloxetine, Neuralgia, Diabetic Neuropathies, Anxiety Disorders, Depressive Disorder, Major
Date of authorisation: 19/06/2015,, Revision: 13, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Bortezomib Sun (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 9, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Memantine LEK (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,
Date of refusal: 21/02/2013,, Revision: 5, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Repaglinide Krka (updated)
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/11/2009,, Revision: 6, Authorised, Last updated: 12/11/2020
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz (updated)
ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 8, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Atosiban SUN (updated)
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,, Revision: 8, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Pemetrexed Accord (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 5, Authorised, Last updated: 05/11/2020