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462 results
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Human medicine European public assessment report (EPAR): Posaconazole AHCL
posaconazole, Mycoses
Date of authorisation: 25/07/2019,
, Revision: 5, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Teva
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 12/12/2022,, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Olanzapine Glenmark Europe
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 03/12/2009,, Revision: 14, Authorised, Last updated: 20/12/2022
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Human medicine European public assessment report (EPAR): Olanzapine Glenmark
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 03/12/2009,, Revision: 15, Authorised, Last updated: 20/12/2022
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 7, Authorised, Last updated: 19/12/2022
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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): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,
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, Revision: 10, Authorised, Last updated: 13/12/2022
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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): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,, , Revision: 6, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 26, Authorised, Last updated: 06/12/2022
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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): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 15, 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): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,
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, Revision: 5, Withdrawn, 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): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 17, Authorised, Last updated: 29/11/2022
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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