3969 results
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Human medicine European public assessment report (EPAR): Fexeric
ferric citrate coordination complex, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 23/09/2015,
, Revision: 2, Withdrawn, Last updated: 04/02/2020
ferric citrate coordination complex Overview This marketing authorisation … gt;FexericEMEA/H/C/003776ferric citrate coordination complexferric citrate coordination complexHyperphosphatemiaRenal DialysisV03AE This medicine … ferric citrate coordination complex ferric citrate coordination complex … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fexeric, ferric citrate coordination complex
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001213-PIP02-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 15/06/2016, Last updated: 07/03/2019, Compliance check: Xferric citrate coordination complex Uro-nephrologyP/0160/2016EMEA-001213-PIP02-12-M02 … ferric citrate (coordination complex) (EMEA-001213-PIP02-12-M02 … ferric citrate (coordination complex) (EMEA-001213-PIP02-12-M02 … -
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Orphan designation: Refusal of orphan designation for the treatment of carcinoma in situ of the urinary bladder
Date of refusal of designation: 18/12/2002, Negative, Last updated: 14/01/2003Mycobacterial cell wall complex Overview On 12 September … for Mycobacterial cell wall complex in the treatment of superficial … of mycobacterial cell wall complex for treatment of carcinoma … -
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Referral: Botox
Clostridium botulinum type A neurotoxin complex, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/02/2003, EC decision date: 25/06/2003, Last updated: 16/10/2003botulinum toxin type A neurotoxin complex] inhibits the release of acetylcholine … Botulinum type A neurotoxin complex: Background information PDF … botulinum type A neurotoxin complexAbout this procedureCPMP/4260/03 … -
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Orphan designation: Recombinant human apolipoprotein A-I in a complex with phospholipids for: Treatment of apolipoprotein A-I deficiency
Date of designation: 22/08/2014, Positive, Last updated: 01/10/2014human apolipoprotein A-I in a complex with phospholipids Overview … human apolipoprotein A-I in a complex with phospholipids for the … human apolipoprotein A-I in a complex with phospholipids for the … -
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Orphan designation: Recombinant human apolipoprotein A-I in a complex with phospholipids for: Treatment of ATP-binding cassette transporter A1 deficiency
Date of designation: 22/08/2014, Positive,human apolipoprotein A-I in a complex with phospholipids Overview … human apolipoprotein A-I in a complex with phospholipids for the … human apolipoprotein A-I in a complex with phospholipids for the … -
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Orphan designation: Parathyroid hormone (1-34) transglutaminase fusion protein fibrin matrix complex for: Treatment of solitary bone cysts
Date of designation: 11/04/2006, Positive, Last updated: 24/04/2009fusion protein fibrin matrix complex Overview On 11 April 2006 … fusion protein fibrin matrix complex for the treatment of solitary … fusion protein fibrin matrix complex is composed by a part (sequence … -
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Orphan designation: Autologous Tumor-Derived gp96 Heat Shock Protein-Peptide Complex for: Treatment of glioma
Date of designation: 29/04/2009, Positive, Last updated: 12/05/2009Heat Shock Protein-Peptide Complex Overview On 29 April 2009 … heat shock protein-peptide complex for the treatment of glioma … heat shock protein-peptide complex might be of significant benefit … -
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Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology; Ophthalmology
PIP number: EMEA-001039-PIP02-12-M04, Route(s) of administration: Intraglandular use, Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 30/03/2020, Last updated: 16/09/2021, Compliance check: V, 24/07/2020type A (150 kD), free from complexing proteins NeurologyOphthalmologyP/0125/2020EMEA-001039-PIP02-12-M04 … type A (150 kD), free of complexing proteins, (Xeomin, Bocouture … type A (150 kD), free from complexing proteins … -
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Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001039-PIP03-17, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 13/04/2018, Last updated: 26/07/2018, Compliance check: Xtype A (150 kD), free from complexing proteins OphthalmologyP/0131/2018EMEA-001039-PIP03-17 … type A (150 kD), free from complexing proteins (Xeomin, Bocouture … type A (150 kD), free from complexing proteins (Xeomin, Bocouture … -
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Opinion/decision on a Paediatric investigation plan (PIP): Clostridium botulinum neurotoxin type A (150 kD), free of complexing proteins
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001039-PIP01-10-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 15/12/2017type A (150 kD), free of complexing proteins NeurologyP/0157/2016EMEA-001039-PIP01-10-M02 … type A (150 kD), free of complexing proteins (Xeomin, Bocoutur … type A (150 kD), free of complexing proteins (Xeomin, Bocouture … -
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Opinion/decision on a Paediatric investigation plan (PIP): Iron, aqua carbonate hydroxy oxo starch sucrose complex
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000100-PIP01-07-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 03/05/2010, Last updated: 28/07/2010, Compliance check: Xhydroxy oxo starch sucrose complex Endocrinology, -gynacology-fertility-metabolismP/64/2010EMEA-000100-PIP01-07-M01 … hydroxy oxo starch sucrose complex (EMEA-000100-PIP01-07-M01 … hydroxy oxo starch sucrose complex (EMEA-000100-PIP01-07-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology; Ophthalmology
PIP number: EMEA-001039-PIP03-17, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection, Solution for injection in pre-filled syringe
Decision date: 12/10/2018, Last updated: 11/01/2019, Compliance check: Xtype A (150 kD), free from complexing proteins NeurologyOphthalmologyP/0338/2018EMEA-001039-PIP03-17 … type A (150 kD), free from complexing proteins (Xeomin, Bocouture … type A (150 kD), free from complexing proteins … -
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Orphan designation: Codon-optimised human ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles for: Treatment of ornithine transcarbamylase deficiency
Date of designation: 27/06/2018, Withdrawn, Last updated: 28/04/2021ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles … ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles … ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles … -
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Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against claudin-5 complexed with polyethyleneimine for: Treatment of glioma
Date of designation: 08/11/2012, Withdrawn, Last updated: 17/05/2017directed against claudin-5 complexed with polyethyleneimine Overview … directed against claudin-5 complexed with polyethyleneimine (prior … directed against claudin-5 complexed with polyethyleneimine (prior … -
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Orphan designation: Autologous Tumor-Derived gp96 Heat Shock Protein-Peptide Complex for: Treatment of renal-cell carcinoma
Date of designation: 11/04/2005, Positive, Last updated: 04/01/2006Heat Shock Protein-Peptide Complex Overview On 11 April 2005 … heat shock proteinpeptide complex for the treatment of renal … heat shock protein-peptide complex might be of potential significant … -
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Orphan designation: Highly branched poly (beta-amino ester) complexed with a nanoplasmid containing the human COL7A1 gene for: Treatment of epidermolysis bullosa
Date of designation: 19/10/2020, Positive, Last updated: 16/02/2021branched poly (beta-amino ester) complexed with a nanoplasmid containing … branched poly(beta-amino ester) complexed with a nanoplasmid containing … branched poly(beta-amino ester) complexed with a nanoplasmid containing … -
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Orphan designation: Ribonucleoprotein complex composed of two sgRNA and a Cas9 nuclease targeting the human COL7A1 gene for: Treatment of epidermolysis bullosa
Date of designation: 10/12/2021, Positive, Last updated: 20/04/2022Ribonucleoprotein complex composed of two sgRNA and … Ribonucleoprotein complex composed of two sgRNA and … -
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Opinion/decision on a Paediatric investigation plan (PIP): Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complexes
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002293-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: XN,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complexes OncologyP/0115/2018EMEA-002293-PIP01-17 … methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complex... PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Procomvax
polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC, outer membrane protein complex of Neisseria meningitidis (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B), adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae), Hepatitis B; Meningitis, Haemophilus; Immunization
Date of authorisation: 07/05/1999, Revision: 9, Withdrawn, Last updated: 29/07/2009PRP-OMPCouter membrane protein complex of Neisseria meningitidis … meningitidis (outer membrane protein complex of the B11 strain of Neisseria … PRP-OMPC outer membrane protein complex of Neisseria meningitidis … -
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Orphan designation: L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-complex with keyhole limpet haemocyanin for: Treatment of glioma
Date of designation: 27/10/2011, Withdrawn, Last updated: 04/12/2020L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-complex with keyhole limpet haemocyanin … L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-complex with keyhole limpet haemocyan … -
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Orphan designation: Plasmid DNA encoding the human cystic fibrosis transmembrane conductance regulator gene complexed with a non-viral, cationic lipid based gene transfer agent for: Treatment of cystic fibrosis
Date of designation: 04/06/2014, Positive, Last updated: 10/07/2014conductance regulator gene complexed with a non-viral, cationic … conductance regulator gene complexed with a non-viral, cationic … lipid (fat) mixture to make a complex that can enter the cell … -
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Opinion/decision on a Paediatric investigation plan (PIP): L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-α -aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001810-PIP01-15, Route(s) of administration: Intradermal use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 30/10/2015, Last updated: 22/12/2015, Compliance check: Xaspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin … aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin … aspartyl-L-histidyl-S-[1-[(4- carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humanized immunoglobulin (lg) G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation (CD) 3 receptor complex and B-cell maturation antigen (BCMA)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002650-PIP01-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 29/01/2020, Last updated: 10/06/2020, Compliance check: Xdifferentiation (CD) 3 receptor complex and B-cell maturation antigen … differentiation (CD) 3 receptor complex.. PDF icon application/pdf … differentiation (CD) 3 receptor complex and B-cell maturation antigen … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pneumococcal polysaccharides individually biotinylated and complexed with a carrier protein (recombinant fusion construct of rhizavidin and Streptococcus pneumoniae derived proteins), 24-valent
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002641-PIP01-19, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 18/04/2020, Last updated: 05/03/2021, Compliance check: Xindividually biotinylated and complexed with a carrier protein (recombinant … individually biotinylated and complexed with a carrier protein (recombinant … individually biotinylated and complexed with a carrier protein (recombinant …