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Human medicine European public assessment report (EPAR): Levetiracetam Hospira (updated)

levetiracetam, Epilepsy
Date of authorisation: 07/01/2014, , Revision: 16, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Defitelio (updated)

defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013, , , , Revision: 13, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Nilemdo (updated)

Bempedoic acid, Hypercholesterolemia, Dyslipidemias
Date of authorisation: 01/04/2020, , Revision: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Xeljanz (updated)

tofacitinib citrate, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,
Date of refusal: 25/04/2013, , , Revision: 16, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Keytruda (updated)

Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015, , Revision: 31, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Zynteglo (updated)

Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019, , , , , Revision: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Lorviqua (updated)

Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019, , , Revision: 5, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)

Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020, , , Revision: 2, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)

deferasirox, Iron Overload, beta-Thalassemia
Date of authorisation: 26/09/2019, , Revision: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Doptelet (updated)

avatrombopag maleate, Thrombocytopenia
Date of authorisation: 20/06/2019, , Revision: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Strimvelis (updated)

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016, , , Revision: 5, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Kyprolis (updated)

carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015, , , Revision: 18, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Piqray (updated)

Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020, , Revision: 1, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Telmisartan Teva Pharma (updated)

telmisartan, Hypertension
Date of authorisation: 03/10/2011, , Revision: 8, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)

tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016, , Revision: 8, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Darunavir Krka (updated)

darunavir, HIV Infections
Date of authorisation: 26/01/2018, , Revision: 6, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): Ibandronic Acid Teva (updated)

ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, Osteoporosis, Postmenopausal
Date of authorisation: 17/09/2010, , Revision: 10, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Coagadex (updated)

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , , Revision: 6, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)

acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 09/01/2020, , Revision: 4, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): Alunbrig (updated)

brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018, , Revision: 5, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Lojuxta (updated)

Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013, , , Revision: 13, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)

telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013, , Revision: 12, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): Lutathera (updated)

lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017, , , Revision: 4, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)

tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016, , Revision: 11, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , , Revision: 15, Authorised, Last updated: 26/01/2021

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879 results

Human medicine European public assessment report (EPAR): Levetiracetam Hospira (updated)

Human medicine European public assessment report (EPAR): Defitelio (updated)

Human medicine European public assessment report (EPAR): Nilemdo (updated)

Human medicine European public assessment report (EPAR): Xeljanz (updated)

Human medicine European public assessment report (EPAR): Keytruda (updated)

Human medicine European public assessment report (EPAR): Zynteglo (updated)

Human medicine European public assessment report (EPAR): Lorviqua (updated)

Human medicine European public assessment report (EPAR): Comirnaty (updated)

Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)

Human medicine European public assessment report (EPAR): Doptelet (updated)

Human medicine European public assessment report (EPAR): Strimvelis (updated)

Human medicine European public assessment report (EPAR): Kyprolis (updated)

Human medicine European public assessment report (EPAR): Piqray (updated)

Human medicine European public assessment report (EPAR): Telmisartan Teva Pharma (updated)

Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)

Human medicine European public assessment report (EPAR): Darunavir Krka (updated)

Human medicine European public assessment report (EPAR): Ibandronic Acid Teva (updated)

Human medicine European public assessment report (EPAR): Coagadex (updated)

Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)

Human medicine European public assessment report (EPAR): Alunbrig (updated)

Human medicine European public assessment report (EPAR): Lojuxta (updated)

Human medicine European public assessment report (EPAR): Actelsar HCT (updated)

Human medicine European public assessment report (EPAR): Lutathera (updated)

Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)

Human medicine European public assessment report (EPAR): Darzalex (updated)