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858 results
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Human medicine European public assessment report (EPAR): Mvabea (updated)
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,
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, Revision: 4, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, 
, Revision: 18, 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): Voxzogo (updated)
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,, , Revision: 4, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Herwenda (updated)
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 15/11/2023,, 
, Authorised, Last updated: 23/11/2023
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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): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
Single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021,
, , Revision: 41, Authorised, Last updated: 21/11/2023
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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): Fetcroja (updated)
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 7, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Respreeza (updated)
Human alpha1-proteinase inhibitor, Genetic Diseases, Inborn; Lung Diseases
Date of authorisation: 20/08/2015,, Revision: 12, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Vanflyta (updated)
Quizartinib dihydrochloride, Leukemia, Myeloid
Date of authorisation: 06/11/2023,, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Exjade (updated)
deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006,, Revision: 52, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Esperoct (updated)
Turoctocog alfa pegol, Hemophilia A
Date of authorisation: 20/06/2019,, Revision: 6, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Tepmetko (updated)
Tepotinib hydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2022,, Revision: 2, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Obizur (updated)
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 11, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Vimizim (updated)
recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014,, , Revision: 13, Authorised, Last updated: 20/11/2023
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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): 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): Ajovy (updated)
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 10, 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): Leqvio (updated)
inclisiran, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 09/12/2020,, Revision: 5, 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): Wakix (updated)
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 15, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Gazyvaro (updated)
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,, , Revision: 16, Authorised, Last updated: 20/11/2023