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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,
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, Revision: 17, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, Revision: 38, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Soliris (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, , Revision: 36, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 13, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,
, Revision: 1, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Tecartus (updated)
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: 5, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Holoclar (updated)
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 10, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 8, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 9, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Talvey (updated)
talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023,, , , Revision: 1, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 17, Authorised, Last updated: 22/11/2023
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Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , Revision: 12, Authorised, Last updated: 22/11/2023
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Human medicine European public assessment report (EPAR): Gavreto (updated)
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,, , Revision: 6, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 16, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Tagrisso (updated)
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 19, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , Revision: 21, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 5, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Jaypirca (updated)
pirtobrutinib, Lymphoma, Mantle-Cell
Date of authorisation: 30/10/2023,, , Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Posaconazole AHCL (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 6, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Lumykras (updated)
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,, , Revision: 2, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,, Revision: 17, Authorised, Last updated: 13/11/2023
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Human medicine European public assessment report (EPAR): Silodosin Recordati (updated)
silodosin, Prostatic Hyperplasia
Date of authorisation: 07/01/2019,, Revision: 2, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Lunsumio (updated)
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , , Revision: 2, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,, Revision: 8, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Degarelix Accord (updated)
degarelix acetate, Prostatic Neoplasms
Date of authorisation: 29/09/2023,, Authorised, Last updated: 08/11/2023