5159 results
Keyword Freamine III Remove keyword
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Veterinary medicine European public assessment report (EPAR): Forceris
toltrazuril, iron (III) ion, Pigs (piglets)
Date of authorisation: 23/04/2019, Revision: 1, Authorised, Last updated: 04/04/2022Authorised toltrazuriliron (III) ion Overview Forceris is … Toltrazuril 30.0 mg Iron (III) 133.4 mg (as gleptoferron … Forceris toltrazuril iron (III) ion iron III) ion … -
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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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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Date of designation: 30/04/2002, Withdrawn, Last updated: 20/10/2016Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein Overview … pseudomonas exotoxin (domains II/III)-interleukin 13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Date of designation: 15/02/2007, Withdrawn, Last updated: 20/10/2016HLA class I/II binding tumour associated … GmbH, Germany, for HLA class I/II binding tumour associated … cell carcinoma.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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Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues for: Treatment of familial chylomicronaemia syndrome
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021against apolipoprotein C-III mRNA and covalently linked … against apolipoprotein C-III mRNA and covalently linked … against apolipoprotein C-III mRNA and covalently linked … -
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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)
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 … area (MeSH) Antithrombin III Deficiency Anatomical therapeutic … -
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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): Talmanco (previously Tadalafil Generics) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,
, Revision: 7, Authorised, Last updated: 09/06/2022
physical activity) or class-III (marked limitation of physical … physical activity) or class-III (marked limitation of physical … -
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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: 14, Authorised, Last updated: 12/04/2022
annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … -
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan (updated)
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 3, Authorised, Last updated: 29/06/2022
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): Ritemvia
rituximab, Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 8, Withdrawn, Last updated: 16/08/2021
annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … -
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Human medicine European public assessment report (EPAR): Mekinist
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 27, Authorised, Last updated: 05/05/2022dabrafenib; advanced (stage III) melanoma after surgery for … dabrafenib; • advanced (stage III) melanoma after surgery for … involving 870 patients with stage III melanoma that had been removed … -
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Human medicine European public assessment report (EPAR): Tracleer
bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 41, Authorised, Last updated: 29/10/2021treat patients with class III pulmonary arterial hypertension … of the disease: ‘class III’ PAH involves marked limitation … functional class II and III have a mean survival of 3.5 … -
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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: 7, Authorised, Last updated: 21/03/2022
marketing authorisation Annex IIIA - Labelling Annex IIIB - Package leaflet Please … -
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Human medicine European public assessment report (EPAR): Granpidam
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 6, Authorised, Last updated: 21/12/2021
physical activity) or class III (marked limitation of physical … physical activity) or class III (marked limitation of physical … -
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Human medicine European public assessment report (EPAR): Ventavis
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 29, Authorised, Last updated: 13/12/2021adult 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): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 3, Authorised, Last updated: 30/05/2022
annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … -
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Human medicine European public assessment report (EPAR): Tafinlar
dabrafenib mesilate, Melanoma
Date of authorisation: 26/08/2013, Revision: 27, Authorised, Last updated: 09/12/2021trametinib; advanced (stage III) melanoma after surgery for … trametinib; • advanced (stage III) melanoma after surgery for … involving 870 patients with stage III melanoma that had been removed … -
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, , Revision: 3, Withdrawn, Last updated: 25/11/2021
marketing authorisation Annex IIIA - Labelling Annex IIIB - Package leaflet Please … Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian … -
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Human medicine European public assessment report (EPAR): Caspofungin Accord
caspofungin acetate, Candidiasis; Aspergillosis
Date of authorisation: 11/02/2016,, Revision: 6, Withdrawn, Last updated: 20/08/2021
annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … -
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Human medicine European public assessment report (EPAR): Lumoxiti
Moxetumomab pasudotox, Leukemia, Hairy Cell
Date of authorisation: 08/02/2021, Withdrawn, Last updated: 11/08/2021annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). …