5589 results
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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Date of designation: 30/04/2002, Withdrawn, Last updated: 20/10/2016Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein … Pseudomonas exotoxin (domains II/III)-Interleukin 13 chimeric protein for the … 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Date of designation: 15/02/2007, Withdrawn, Last updated: 20/10/2016HLA class I/II binding tumour associated … designation of HLA class I/II binding tumour associated … DESIGNATION OF HLA class I/II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 … -
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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,
, 
, Revision: 16, Withdrawn, Last updated: 02/07/2019
ATryn Antithrombin III Deficiency … area (MeSH) Antithrombin III Deficiency Anatomical therapeutic … -
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Direct healthcare professional communication (DHPC): Adakveo (crizanlizumab): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo
Active substance: Crizanlizumab, DHPC type: Referral - Article 20 procedure, Last updated: 14/02/2023akveo (crizanlizumab): Phase III study (CSEG101A2301) shows … akveo (crizanlizumab): Phase III study (CSEG101A2301) shows … KVEO (crizanlizumab): Phase III study (CSEG101A2301) shows … -
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ICH Q1F Stability data package for registration in climatic zones III and IV - Scientific guideline
Last updated: 01/06/2006registration in climatic zones III and IV - Scientific guideline … registration in climatic zones III and IV - Scientific guideline … 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 - Scientific guideline
Last updated: 17/12/2019products in climatic zones III and IV - Scientific guideline … products in climatic zones III and IV - Scientific guideline … 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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Adaptive pathways workshop
European Medicines Agency, UK, 08/12/2016, Last updated: 23/02/2017Generic Presentation - The Salford Lung Study (Ashley Woodcock … -
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Human medicine European public assessment report (EPAR): Enerzair Breezhaler
indacaterol, Glycopyrronium bromide, mometasone, Asthma
Date of authorisation: 03/07/2020, Revision: 4, Authorised, Last updated: 17/03/2023authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … Association (NYHA) class III/IV left ventricular failure … -
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Human medicine European public assessment report (EPAR): Zimbus Breezhaler
Glycopyrronium bromide, Indacaterol (acetate), Mometasone furoate, Asthma
Date of authorisation: 03/07/2020, Revision: 3, Authorised, Last updated: 09/12/2021authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … Association (NYHA) class III/IV left ventricular failure … -
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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: 18, Authorised, Last updated: 02/02/2023
authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … -
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Human medicine European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 01/10/2008, Revision: 16, Authorised, Last updated: 12/05/2023physical activity) and PAH class III (where patients have marked … whom had class II or class III disease. Before treatment … activity) and PAH class III (where patients have marked … -
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Human medicine European public assessment report (EPAR): DepoCyte
cytarabine, Meningeal Neoplasms
Date of authorisation: 11/07/2001, Revision: 15, Withdrawn, Last updated: 03/04/2023authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … -
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,
, Revision: 1, Withdrawn, Last updated: 30/03/2023
authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … -
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Withdrawn, Last updated: 30/03/2023
authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). … -
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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: 10, Authorised, Last updated: 13/12/2022
authorisation (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: 28, Authorised, Last updated: 27/02/2023trametinib; 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): Mekinist
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 29, Authorised, Last updated: 27/02/2023dabrafenib; 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): Bemrist Breezhaler
indacaterol, Mometasone furoate, Asthma
Date of authorisation: 30/05/2020, Revision: 5, Authorised, Last updated: 02/02/2023medicine. labelling (annex IIIA); The leaflet in every pack … package leaflet (annex IIIB). … Association (NYHA) class III/IV left ventricular failure … -
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Human medicine European public assessment report (EPAR): Stayveer
bosentan (as monohydrate), Hypertension, Pulmonary; Scleroderma, Systemic
Date of authorisation: 24/06/2013, Revision: 15, Authorised, Last updated: 13/02/2023treat 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 …