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Medicine
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Human medicine European public assessment report (EPAR): Pioglitazone Accord (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012,
, Revision: 6, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Imbruvica (updated)
Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014,
, Revision: 21, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Vpriv (updated)
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,
, , Revision: 14, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Lamivudine Teva (updated)
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 10, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 16, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Myfenax (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 23, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,
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, Revision: 3, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 3, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,, Revision: 11, Authorised, Last updated: 25/02/2021
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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: 9, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 14, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, , Revision: 11, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, , Revision: 9, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 7, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm (updated)
levetiracetam, Epilepsy
Date of authorisation: 26/08/2011,, Revision: 11, Authorised, Last updated: 22/02/2021
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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: 11, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 6, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 20, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Palonosetron Accord (updated)
Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Apotex) (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 20, Authorised, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 5, Authorised, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 8, Authorised, Last updated: 16/02/2021
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Human medicine European public assessment report (EPAR): Mysildecard (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 3, Authorised, Last updated: 15/02/2021