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Medicine
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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): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,
, 
, 
, Revision: 17, 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Date of authorisation: 10/06/2010,, Revision: 10, Withdrawn, Last updated: 23/11/2020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): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, 
, , Revision: 14, 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): Myalepta (updated)
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 4, 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): Ofev (updated)
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 15, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Isentress (updated)
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 37, Authorised, Last updated: 16/11/2020
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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): Cabometyx (updated)
cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,, , Revision: 9, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Defitelio (updated)
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 12, Authorised, Last updated: 05/11/2020
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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
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Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , , Revision: 10, Authorised, Last updated: 03/11/2020
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Human medicine European public assessment report (EPAR): Ifirmacombi (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 04/03/2011,, Revision: 11, Authorised, Last updated: 30/10/2020
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Human medicine European public assessment report (EPAR): Cinacalcet Mylan (updated)
cinacalcet (as hydrochloride), Hyperparathyroidism, Secondary, Hypercalcemia
Date of authorisation: 19/11/2015,, Revision: 8, Authorised, Last updated: 29/10/2020
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Human medicine European public assessment report (EPAR): Docetaxel Kabi (updated)
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
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Human medicine European public assessment report (EPAR): Docetaxel Accord (updated)
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020