119 results
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Human medicine European public assessment report (EPAR): VeraSeal
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 10/11/2017,
, Revision: 5, Authorised, Last updated: 05/01/2022
worked better than manual compression, with 76% of patients having … compared with 23% after manual compression (13 out of 57). In a second … intermittent application of compresses, swabs, use of suction devices … -
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Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for: Treatment of achondroplasia
Date of designation: 24/01/2013, Positive, Last updated: 09/09/2021bowed legs, ear problems, compression of the spinal cord, as well … length, to correct spinal compression or to correct bowed legs … bowed legs, ear problems, compression of the spinal cord, as well … -
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Human medicine European public assessment report (EPAR): Xofigo
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 12, Authorised, Last updated: 07/07/2022
pathological fractures, spinal cord compression and use of radiation to relieve … -
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, 
, Revision: 8, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Orkambi (updated)
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015,, Revision: 29, Authorised, Last updated: 25/07/2022
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Human medicine European public assessment report (EPAR): Orgovyx (updated)
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,, Revision: 4, Authorised, Last updated: 17/08/2022
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Human medicine European public assessment report (EPAR): Zynquista (updated)
Sotagliflozin, Diabetes Mellitus, Type 1
Date of authorisation: 26/04/2019,, Revision: 3, Withdrawn, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Nexpovio (updated)
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,, Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Yescarta
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 8, Authorised, Last updated: 12/07/2022
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , 
, Revision: 13, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,, 
, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Lunsumio
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , , Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,, 
, Revision: 21, Authorised, Last updated: 25/05/2022
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 1, Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): Nerlynx
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,, Revision: 11, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Erleada
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 7, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Symkevi
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, , Revision: 10, Authorised, Last updated: 07/06/2022
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Human medicine European public assessment report (EPAR): Xofluza (updated)
Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021,, Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, , Revision: 22, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Pemazyre
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 3, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Venclyxto (updated)
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 14, Authorised, Last updated: 19/08/2022
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Human medicine European public assessment report (EPAR): Kymriah
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 11, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,, Revision: 22, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Juluca
dolutegravir sodium, rilpivirine hydrochloride, HIV Infections
Date of authorisation: 16/05/2018,, Revision: 9, Authorised, Last updated: 24/03/2022
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Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, , Revision: 4, Authorised, Last updated: 27/06/2022