338 results
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 6, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Nityr
nitisinone, Tyrosinemias
Date of authorisation: 26/07/2018,, Revision: 3, Authorised, Last updated: 15/12/2022
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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: 20, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Repaglinide Krka
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/11/2009,, Revision: 8, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Enyglid
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2009,, Revision: 9, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 3, Authorised, Last updated: 12/12/2022
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Human medicine European public assessment report (EPAR): Striascan
ioflupane (123l), Radionuclide Imaging; Dementia; Movement Disorders
Date of authorisation: 25/06/2019,, Revision: 2, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 9, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Mysildecard
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 7, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 11, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Sorafenib Accord
Sorafenib tosilate, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 09/11/2022,, Authorised, Last updated: 25/11/2022
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 8, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Ibandronic Acid Teva
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone; Osteoporosis, Postmenopausal
Date of authorisation: 17/09/2010,, Revision: 12, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Olanzapine Teva
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 29, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,, Revision: 14, Authorised, Last updated: 21/11/2022
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Human medicine European public assessment report (EPAR): Ertapenem SUN
ertapenem sodium, Bacterial Infections
Date of authorisation: 15/07/2022,, Authorised, Last updated: 21/11/2022
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 13, Authorised, Last updated: 18/11/2022
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma
Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022,, Revision: 2, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Lamivudine Teva
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 13, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm
clopidogrel (as hydrogen sulfate), Myocardial Infarction; Acute Coronary Syndrome; Peripheral Vascular Diseases; Stroke
Date of authorisation: 18/02/2015,, Revision: 14, Authorised, Last updated: 15/11/2022
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Human medicine European public assessment report (EPAR): Iasibon
ibandronic acid, Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms
Date of authorisation: 21/01/2011,, Revision: 11, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Teriflunomide Accord
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Miglustat Dipharma
miglustat, Gaucher Disease
Date of authorisation: 18/02/2019,, Revision: 4, Authorised, Last updated: 11/11/2022
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Human medicine European public assessment report (EPAR): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 12, Authorised, Last updated: 04/11/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 9, Authorised, Last updated: 03/11/2022