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Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,,
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, Revision: 18, Authorised, Last updated: 02/03/2021
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Human medicine European public assessment report (EPAR): Bortezomib Sun
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 10, Authorised, Last updated: 01/03/2021
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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: 10, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Epidyolex
Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 5, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Pioglitazone Teva
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 11, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Ondexxya
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,,
, Revision: 8, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Pioglitazone Accord
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
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
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
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)
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
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): Entecavir Mylan
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): Pregabalin Accord
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
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
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
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
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.
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
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
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,,
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, Revision: 11, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
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): Palonosetron Accord
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
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,,
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, 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)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 20, Authorised, Last updated: 17/02/2021