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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, , , , 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, , , , , 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
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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