4998 results
Keyword Freamine III Remove keyword
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Veterinary medicine European public assessment report (EPAR): Baycox Iron
Iron(iii) ion, toltrazuril, Pigs (piglets)
Date of authorisation: 20/05/2019, Authorised, Last updated: 07/04/2020Authorised toltrazuriliron (III) ion Overview Baycox Iron … Toltrazuril 36.4 mg Iron (III) 182 mg (as gleptoferron … Iron toltrazuril iron (III) ion Iron iii) ion … -
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Veterinary medicine European public assessment report (EPAR): Forceris
toltrazuril, iron (III) ion, Pigs (piglets)
Date of authorisation: 23/04/2019, Authorised, Last updated: 16/05/2019Authorised toltrazuriliron (III) ion Overview Forceris is … Forceris toltrazuril iron (III) ion iron III) ion … -
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Orphan designation: Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein for: Treatment of glioma
Date of designation: 30/04/2002, Withdrawn, Last updated: 20/10/2016Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein Overview … pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein [hIL13-PE-38QQR … pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein for the … -
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Orphan designation: [5,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III) chloride for: Treatment of Cockayne syndrome
Date of designation: 12/01/2017, Positive, Last updated: 13/07/20175,10,15,20-тетракис(4-карбоксифенил)-21H,23H- порфин]манганов(III) хлорид Лечение … 5,10,15,20-tetrakis(4-karboksifenil)-21H,23H- porfin]mangan(III) klorid Liječenje sindroma … 5,10,15,20-tetrakis(4-karboxyfenyl)-21H,23H- porfin]mangan(III) chlorid Léčba Cockaynova … -
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Orphan designation: HLA class I/II binding tumour associated peptides (ADF-APO-CCN-GUC-K67-MET-MMP-MUC-RGS) for: Treatment of renal-cell carcinoma
Date of designation: 15/02/2007, Withdrawn, Last updated: 20/10/2016HLA class I/II binding tumour associated … GmbH, Germany, for HLA class I/II binding tumour associated … cell carcinoma. HLA class I/II binding tumour associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cluster of differentiation 40 (CD40) ligand antagonist comprising two identical Tn3 modules fused to human serum albumin, with each Tn3 module being an engineered form of the third fibronectin type III protein domain of human Tenascin C (VIB4920) (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002825-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: Xthe third fibronectin type III protein domain of human Tenascin … the third fibronectin type III protein domain of human Tenascin … the third fibronectin type III protein domain of human Tenascin … -
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Human medicine European public assessment report (EPAR): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,
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, Revision: 16, Withdrawn, Last updated: 02/07/2019
ATryn Antithrombin III Deficiency … -
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ICH Q1F Stability data package for registration in climatic zones III and IV
Last updated: 01/06/2006registration in climatic zones III and IV … registration in climatic zones III and IV PDF icon application/pdf … Applications in Climatic Zones III and IV European …
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VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV
Last updated: 13/12/2019products in climatic zones III and IV … regions in the climatic zones III and IV … Products in Climatic Zones III and IV Draft agreed …
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Press release: European Medicines Agency concludes review of modified-release oral opioids of the WHO level III scale for the management of pain
Last updated: 23/07/2010opioids of the WHO level III scale for the management … opioids of the WHO level III scale for the management … opioids of the WHO level III scale for the management … -
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,
, Revision: 2, Authorised, Last updated: 23/03/2021
patients with class II or III disease. The ‘class’ … physical activity and ‘class III’ involves marked limitation … Functional Class (FC) II to III, including use in combination … -
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Human medicine European public assessment report (EPAR): Ventavis
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 28, Authorised, Last updated: 01/02/2021adult patients with class III primary pulmonary hypertension … by the disease: ‘class III’ involves marked limitation … adults with stable class III or IV pulmonary hypertension … -
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Human medicine European public assessment report (EPAR): Opsumit
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,
, Revision: 18, Authorised, Last updated: 18/06/2021
functional class II to class III. The class reflects the seriousness … activity and those with class III disease have marked limitation … functional class II to class III. The class reflects the seriousness … -
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Human medicine European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 01/10/2008, Revision: 13, Authorised, Last updated: 10/02/2021patients with class-II or -III disease. The ‘class’ … physical activity and ‘class III’ involves marked limitation … whom had class-II or class-III disease that was of unknown … -
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Human medicine European public assessment report (EPAR): Volibris
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/04/2008, Revision: 21, Authorised, Last updated: 07/05/2021patients with class II or III disease. The ‘class’ … physical activity and ‘class III’ involves marked limitation … most of whom had class II or III disease that was of unknown … -
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Human medicine European public assessment report (EPAR): Riximyo
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 15/06/2017,, 
, Revision: 5, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Rixathon
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 15/06/2017,, , Revision: 4, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Ruxience
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell, Arthritis, Rheumatoid, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 3, Authorised, Last updated: 11/05/2021
marketing authorisation Annex IIIA - Labelling Annex IIIB - Package leaflet Please … adult patients with stage III-IV follicular lymphoma in … adult patients with stage III-IV follicular lymphoma who … -
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Human medicine European public assessment report (EPAR): Revatio
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 41, Authorised, Last updated: 04/12/2020physical activity) or class III (marked limitation of physical … whom had class II or class III disease. Change in exercise … placebo. Adults with class III disease could walk an average … -
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Human medicine European public assessment report (EPAR): Tecnemab K1
anti-melanoma mab fragments, Radioimmunodetection
Date of authorisation: 05/09/1996, Withdrawn, Last updated: 31/12/2009marketing authorisation Annex IIIA - Labelling Annex IIIB - Package leaflet Please … follow-up of patients with stage I-III melanoma. Aid in differential … -
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Human medicine European public assessment report (EPAR): Stayveer (updated)
bosentan (as monohydrate), Hypertension, Pulmonary, Scleroderma, Systemic
Date of authorisation: 24/06/2013, Revision: 14, Authorised, Last updated: 20/07/2021treat patients with class III pulmonary arterial hypertension … of the disease: ‘class III’ PAH involves marked limitation … with WHO functional class III. Efficacy has been shown in … -
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Human medicine European public assessment report (EPAR): Blitzima
rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, , Revision: 10, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Uptravi
Selexipag, Hypertension, Pulmonary
Date of authorisation: 12/05/2016, Revision: 12, Authorised, Last updated: 23/03/2021with functional class II or III PAH. The ‘class’ reflects … physical activity while ‘class III’ involves marked limitation … with functional class II or III PAH. The ‘class’ reflects … -
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Human medicine European public assessment report (EPAR): Aplidin
, Last updated: 26/11/2020
marketing authorisation Annex IIIA - Labelling Annex IIIB - Package leaflet Please … -
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Human medicine European public assessment report (EPAR): Thelin
sitaxentan sodium, Hypertension, Pulmonary
Date of authorisation: 10/08/2006, Revision: 13, Withdrawn, Last updated: 02/03/2011marketing authorisation Annex IIIA - Labelling Annex IIIB - Package leaflet Please … classified as WHO functional class III, to improve exercise capacity … activity) in patients with class III disease. Thelin was marketed …