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415 results
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Human medicine European public assessment report (EPAR): Sildenafil Actavis
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,
, Revision: 15, Authorised, Last updated: 28/06/2022
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Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 25, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 4, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Sun
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 17, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma
Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 12, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 13, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Sildenafil ratiopharm
sildenafil, Erectile Dysfunction
Date of authorisation: 23/12/2009,, Revision: 19, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Imatinib Accord
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 23, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Myfenax
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 26, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan
sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,
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, Revision: 8, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 16, Authorised, Last updated: 20/06/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 01, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 5, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 17, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Evrysdi
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, , Revision: 2, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,, , Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 20, Authorised, Last updated: 15/06/2022
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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: 9, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Hospira
levetiracetam, Epilepsy
Date of authorisation: 07/01/2014,, Revision: 23, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Vidaza
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 25, Authorised, Last updated: 14/06/2022
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 10/06/2022
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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: 18, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 4, Authorised, Last updated: 10/06/2022