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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion filter

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Human medicine European public assessment report (EPAR): Pyrukynd

mitapivat sulfate, Genetic Diseases, Inborn; Anemia, Hemolytic
Date of authorisation: 09/11/2022, , , 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): Tecartus

Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020, , , , Revision: 3, Authorised, Last updated: 02/12/2022
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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Date of authorisation: 29/05/2019, , , , , Revision: 5, Withdrawn, Last updated: 30/11/2022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): Tavneos

Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022, , , Revision: 1, Authorised, Last updated: 25/11/2022
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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): Prevymis

Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018, , Revision: 13, Authorised, Last updated: 24/11/2022
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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): Kinpeygo

budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022, , , , Revision: 2, 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): Vyvgart

Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022, , , Revision: 2, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Imcivree

Setmelanotide, Obesity
Date of authorisation: 16/07/2021, , , Revision: 5, 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): Enjaymo

sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022, , , Authorised, Last updated: 17/11/2022
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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