8084 results
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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Date of designation: 30/04/2002, Withdrawn, Last updated: 20/10/2016Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein … Pseudomonas exotoxin (domains II/III)-Interleukin 13 chimeric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: Autologous collagen type II-specific regulatory T cells for: Treatment of non-infectious uveitis
Date of designation: 16/12/2014, Withdrawn, Last updated: 19/11/2019Autologous collagen type II-specific regulatory T cells … Autologous collagen type II-specific regulatory T cells … -
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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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Human medicine European public assessment report (EPAR): Giapreza
Angiotensin II acetate, Hypotension; Shock
Date of authorisation: 23/08/2019,
, Revision: 3, Authorised, Last updated: 24/03/2023
Authorised angiotensin II Overview Giapreza is a medicine … active substance angiotensin II. How is Giapreza used? The … in Giapreza, angiotensin II, is the same as a hormone … -
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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Date of designation: 15/02/2007, Withdrawn, Last updated: 20/10/2016HLA class I/II binding tumour associated … designation of HLA class I/II binding tumour associated … DESIGNATION OF HLA class I/II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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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001912-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 15/04/2019, Last updated: 30/06/2021, Compliance check: XKey facts Angiotensin II (LJPC-501) Cardiovascular … investigation plan for angiotensin II (LJPC-501) (EMEA-001912-PIP02-16-M02 … Angiotensin II (LJPC-501 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Other
PIP number: EMEA-001912-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 26/09/2016, Last updated: 27/10/2016, Compliance check: XKey facts Angiotensin II (LJPC-501) OtherP/0253/2016EMEA-001912-PIP01-15 … deferral for angiotensin II (LJPC-501) (EMEA-001912-PIP01-15 … deferral for angiotensin II (LJPC-501) (EMEA-001912-PIP01-15) 30 … -
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Orphan designation: 18-(p-(131I)-iodophenyl)octadecyl phosphocholine for: Treatment of multiple myeloma
Date of designation: 17/10/2019, Positive, Last updated: 11/05/202118-(p-(131I)-iodophenyl)octadecyl phosphocholine … 18-(p-(131I)-iodophenyl)octadecyl phosphocholine … -
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Orphan designation: Recombinant human soluble Fc-gamma receptor II b for: Treatment of idiopathic thrombocytopenic purpura
Date of designation: 02/08/2007, Withdrawn, Last updated: 16/10/2019soluble Fc-gamma receptor II b … soluble Fc-gamma receptor II b … -
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Orphan designation: 18-(p-[131I]-iodophenyl)octadecyl phosphocholine for: Treatment of lymphoplasmacytic lymphoma
Date of designation: 19/02/2021, Positive, Last updated: 22/02/202218-(p-[131I]-iodophenyl)octadecyl phosphocholine … 18-(p-[131I]-iodophenyl)octadecyl phosphocholine … -
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Opinion/decision on a Paediatric investigation plan (PIP): 18-(p-[131I]-iodophenyl)octadecyl phosphocholine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002745-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 13/05/2020, Last updated: 05/03/2021, Compliance check: XKey facts 18-(p-[131I]-iodophenyl)octadecyl phosphocholine OncologyP/0169/2020EMEA-002745-PIP01-19 … specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP01-19 … specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP01-19 … -
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Opinion/decision on a Paediatric investigation plan (PIP): 18-(p-[131I]-iodophenyl)octadecyl phosphocholine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002745-PIP02-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: XKey facts 18-(p-[131I]-iodophenyl)octadecyl phosphocholine OncologyP/0011/2021EMEA-002745-PIP02-20 … specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP02-20 … specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP02-20 … -
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Orphan designation: Recombinant human monoclonal antibody against activin receptor type IIB for: Treatment of inclusion body myositis
Date of designation: 09/08/2012, Withdrawn, Last updated: 24/10/2018against activin receptor type IIB … against activin receptor type IIB … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human antibody against activin type IIB receptors
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001286-PIP01-12, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 24/08/2012, Last updated: 18/09/2012, Compliance check: Xantibody against activin type IIB receptors NeurologyP/0201/2012EMEA-001286-PIP01-12 … antibody against activin type IIB receptors (EMEA-001286-PIP01-12 … antibody against activin type IIB receptors (EMEA-001286-PIP01-12 … -
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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: Recombinant fusion protein consisting of the extracellular portion of human activin receptor IIB linked to the human IgG1 Fc domain for: Treatment of Duchenne muscular dystrophy
Date of designation: 26/11/2010, Withdrawn, Last updated: 06/03/2015of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … -
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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of beta thalassaemia intermedia and major
Date of designation: 29/07/2014, Positive, Last updated: 21/03/2023of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … -
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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of myelodysplastic syndromes
Date of designation: 22/08/2014, Positive, Last updated: 18/02/2021of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … -
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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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Orphan designation: A lentiviral vector pseudotyped by the Indiana serotype of the vesicular stomatitis virus G protein encoding an antigen derived from the Tax, HBZ, p12I and p30II HTLV-1 proteins for: Treatment of adult T-cell leukaemia/lymphoma
Date of designation: 15/01/2015, Positive, Last updated: 05/03/2015the Tax, HBZ, p12I and p30II HTLV-1 proteins … the Tax, HBZ, p12I and p30II HTLV-1 proteins for the treatment … the Tax, HBZ, p12I and p30II HTLV-1 proteins for the treatment … -
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Orphan designation: A lentiviral vector pseudotyped by the New-Jersey serotype of the vesicular stomatitis virus G protein encoding an antigen derived from the Tax, HBZ, p12I and p30II HTLV-1 proteins for: Treatment of adult T-cell leukaemia/lymphoma
Date of designation: 15/01/2015, Positive, Last updated: 05/03/2015the Tax, HBZ, p12I and p30II HTLV-1 proteins … the Tax, HBZ, p12I and p30II HTLV-1 proteins for the treatment … the Tax, HBZ, p12I and p30II HTLV-1 proteins for the … -
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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): Nexviadyme (updated)
Avalglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 24/06/2022,, Revision: 2, Authorised, Last updated: 25/05/2023
lycogen Storage Disease Type II Glycogen Storage Disease … lycogen Storage Disease Type II … for batch release (annex IIA); conditions of the The approval … -
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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 …