7820 results
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Human medicine European public assessment report (EPAR): Metalyse
tenecteplase, Myocardial Infarction
Date of authorisation: 23/02/2001, Revision: 22, Authorised, Last updated: 23/01/2023PDF/82.46 KB) (PDF/82.46 KB) German (PDF/104.14 KB) (PDF/104.14 … -
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Human medicine European public assessment report (EPAR): Xofluza
Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021,
, Revision: 4, Authorised, Last updated: 19/01/2023
PDF/121.13 KB) (PDF/121.13 KB) German (PDF/124.13 KB) (PDF/124.13 … -
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Human medicine European public assessment report (EPAR): Cresemba
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,
, Revision: 15, Authorised, Last updated: 17/01/2023
PDF/87.09 KB) (PDF/87.09 KB) German (PDF/87.51 KB) (PDF/87.51 … -
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Human medicine European public assessment report (EPAR): Insulin Human Winthrop
insulin human, Diabetes Mellitus
Date of authorisation: 17/01/2007, Revision: 15, Withdrawn, Last updated: 30/04/2018PDF/505.2 KB) (PDF/505.2 KB) German (PDF/505.38 KB) (PDF/505.38 … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide medac
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,
, Revision: 2, Authorised, Last updated: 26/04/2022
PDF/175.46 KB) (PDF/175.46 KB) German (PDF/177.45 KB) (PDF/177.45 … -
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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
PDF/137.01 KB) (PDF/137.01 KB) German (PDF/138.18 KB) (PDF/138.18 … -
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Human medicine European public assessment report (EPAR): Sotyktu
Deucravacitinib, Psoriasis
Date of authorisation: 24/03/2023,, Authorised, Last updated: 31/03/2023
PDF/135.07 KB) (PDF/135.07 KB) German (PDF/136.89 KB) (PDF/136.89 … -
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Human medicine European public assessment report (EPAR): Nyvepria
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, 
, Revision: 5, Authorised, Last updated: 29/03/2023
PDF/111.64 KB) (PDF/111.64 KB) German (PDF/113.76 KB) (PDF/113.76 … -
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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
PDF/44.77 KB) (PDF/44.77 KB) German (PDF/44.78 KB) (PDF/44.78 … -
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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
PDF/74.01 KB) (PDF/74.01 KB) German (PDF/73.21 KB) (PDF/73.21 … -
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Human medicine European public assessment report (EPAR): Potactasol (updated)
topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 06/01/2011,, Revision: 11, Authorised, Last updated: 01/06/2023
PDF/87.08 KB) (PDF/87.08 KB) German (PDF/87.31 KB) (PDF/87.31 … -
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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: 15, Authorised, Last updated: 30/05/2023
PDF/95.75 KB) (PDF/95.75 KB) German (PDF/96.25 KB) (PDF/96.25 … -
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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: 7, Authorised, Last updated: 30/05/2023
PDF/80.98 KB) (PDF/80.98 KB) German (PDF/81.09 KB) (PDF/81.09 … -
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Human medicine European public assessment report (EPAR): Pazenir
paclitaxel, Breast Neoplasms
Date of authorisation: 06/05/2019,, Revision: 7, Authorised, Last updated: 15/03/2022
PDF/170.37 KB) (PDF/170.37 KB) German (PDF/172.47 KB) (PDF/172.47 … Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands … -
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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
PDF/99.83 KB) (PDF/99.83 KB) German (PDF/99.63 KB) (PDF/99.63 … 5 79108 Freiburg i.Br. Germany Orphan medicinal product … -
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Human medicine European public assessment report (EPAR): Aldara
imiquimod, Condylomata Acuminata; Keratosis; Keratosis, Actinic; Carcinoma, Basal Cell
Date of authorisation: 18/09/1998, Revision: 30, Authorised, Last updated: 20/03/2023PDF/44.67 KB) (PDF/44.67 KB) German (PDF/47.51 KB) (PDF/47.51 … -
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Human medicine European public assessment report (EPAR): Vydura
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 4, Authorised, Last updated: 21/03/2023
PDF/119.71 KB) (PDF/119.71 KB) German (PDF/120.95 KB) (PDF/120.95 … -
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Human medicine European public assessment report (EPAR): Clopidogrel DURA
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/07/2009,, Revision: 6, Withdrawn, Last updated: 10/07/2015
PDF/503.27 KB) (PDF/503.27 KB) German (PDF/503.53 KB) (PDF/503.53 … -
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Human medicine European public assessment report (EPAR): Kaletra
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 60, Authorised, Last updated: 29/11/2022PDF/79.64 KB) (PDF/79.64 KB) German (PDF/80.1 KB) (PDF/80.1 KB … -
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Human medicine European public assessment report (EPAR): Lixiana (updated)
edoxaban tosilate, Stroke; Venous Thromboembolism
Date of authorisation: 19/06/2015, Revision: 16, Authorised, Last updated: 25/05/2023PDF/144.84 KB) (PDF/144.84 KB) German (PDF/146.6 KB) (PDF/146.6 … -
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, Revision: 15, Authorised, Last updated: 17/05/2023
PDF/165.34 KB) (PDF/165.34 KB) German (PDF/167.27 KB) (PDF/167.27 … -
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,, Revision: 16, Authorised, Last updated: 25/05/2023
PDF/94.56 KB) (PDF/94.56 KB) German (PDF/95.38 KB) (PDF/95.38 … -
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Human medicine European public assessment report (EPAR): Onduarp
Telmisartan, Hypertension
Date of authorisation: 24/11/2011, Revision: 2, Withdrawn, Last updated: 02/04/2014PDF/525.51 KB) (PDF/525.51 KB) German (PDF/544.29 KB) (PDF/544.29 … -
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Human medicine European public assessment report (EPAR): Fetcroja
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 5, Authorised, Last updated: 08/03/2023
PDF/108.32 KB) (PDF/108.32 KB) German (PDF/110.4 KB) (PDF/110.4 … -
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Human medicine European public assessment report (EPAR): Veyvondi
vonicog alfa, von Willebrand Diseases
Date of authorisation: 31/08/2018,, Revision: 6, Authorised, Last updated: 06/03/2023
PDF/75.71 KB) (PDF/75.71 KB) German (PDF/76.27 KB) (PDF/76.27 …