2328 results
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,
, Revision: 3, Authorised, Last updated: 27/01/2022
Insulin aspart Sanofi Glucose Metabolism Disorders Metabolic … Insulin aspart Sanofi … MEDICINAL PRODUCT Insulin aspart Sanofi 100 units/ml solution for … -
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi
insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017,, Revision: 8, Authorised, Last updated: 22/03/2023
Insulin lispro Sanofi Glucose Metabolism Disorders Metabolic … Insulin lispro Sanofi … the public Insulin lispro Sanofi insulin lispro This is … -
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Human medicine European public assessment report (EPAR): Truvelog Mix 30
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022,
, , Revision: 1, Authorised, Last updated: 23/03/2023
Authorised insulin aspart Overview Truvelog Mix 30 … active substance insulin aspart combined with protamine to … complications. The insulin aspart in Truvelog Mix 30 is a form … -
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Human medicine European public assessment report (EPAR): NovoMix
insulin aspart, Diabetes Mellitus
Date of authorisation: 01/08/2000, Revision: 28, Authorised, Last updated: 12/11/2020insulin aspart … NovoMix, INN-insulin aspart 7 Westferry Circus, Canary … 1.1 Introduction Insulin Aspart, (IAsp), is a fast-acting … -
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Human medicine European public assessment report (EPAR): NovoRapid
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 32, Authorised, Last updated: 22/03/2023insulin aspart … public NovoRapid insulin aspart This is a summary of the … active substance insulin aspart, a rapid-acting insulin. How … -
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Human medicine European public assessment report (EPAR): Fiasp
insulin aspart, Diabetes Mellitus
Date of authorisation: 09/01/2017, Revision: 8, Authorised, Last updated: 23/09/2021insulin aspart … rapid-acting insulin (insulin aspart) intended to be injected at … rapid-acting insulin called insulin aspart. Fiasp is a solution for injection … -
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 2, Authorised, Last updated: 23/05/2023
Authorised insulin aspart Overview Kirsty is a medicine … active substance insulin aspart. How is Kirsty used? Kirsty … another licensed insulin aspart medicine in maintaining a … -
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Human medicine European public assessment report (EPAR): Ryzodeg
insulin aspart, insulin degludec, Diabetes Mellitus
Date of authorisation: 21/01/2013, Revision: 13, Authorised, Last updated: 23/09/2021insulin degludec / insulin aspart … INN-insulin degludec / insulin aspart 30 Churchill Place … insulin degludec / insulin aspart This is a summary of the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ryzodeg, insulin degludec, insulin aspart
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000479-PIP01-08-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/03/2015, Last updated: 13/11/2015, Compliance check: V, 11/09/2015insulin degludec insulin aspart Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … insulin degludec / insulin aspart (Ryzodeg), (EMEA-000479-PIP01-08-M03 … insulin degludec / insulin aspart (Ryzodeg), (EMEA-000479-PIP01-08-M03 … -
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Orphan designation: Vincaleukoblastin-23-oic acid, O4-deacetyl-, 2-[(2-mercaptoethoxy)carbonyl]hydrazide, disulfide with N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-γ-glutamyl-L-α-aspartyl-L-arginyl-L-α-aspartyl-L-α-aspartyl-L-cysteine for: Treatment of ovarian cancer
Date of designation: 09/02/2012, Withdrawn, Last updated: 21/10/2016N-[4-[[(2-amino-3,4- dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-γ-glutamyl-L-α- aspartyl-L-arginyl-L-α-aspartyl-L-α-aspartyl-L-cysteine for the treatment of ovarian … -
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Orphan designation: Recombinant human aspartylglucosaminidase for: Treatment of aspartylglucosaminuria
Date of designation: 15/01/2015, Withdrawn, Last updated: 25/06/2021designation for the treatment of aspartylglucosaminuria … designation Recombinant human aspartylglucosaminidase for the treatment of aspartylglucosaminuria On 15 January 2015, orphan … Denmark, for recombinant human aspartylglucosaminidase for the treatment of … -
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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: XL-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 … 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 … -
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Orphan designation: Recombinant adeno-associated virus Olig001 containing human aspartoacylase cDNA for: Treatment of Canavan disease
Date of designation: 09/12/2022, Positive, Last updated: 13/03/2023Olig001 containing human aspartoacylase cDNA … Olig001 containing human aspartoacylase cDNA … -
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Orphan designation: Adeno-associated viral vector serotype 9 encoding a codon-optimised human aspartylglucosaminidase transgene for: Treatment of aspartylglucosaminuria
Date of designation: 19/10/2020, Positive, Last updated: 12/02/2021designation for the treatment of aspartylglucosaminuria … a codon-optimised human aspartylglucosaminidase transgene for the treatment … transgene for the treatment of aspartylglucosaminuria On 19 October 2020, orphan … -
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Orphan designation: Recombinant human tissue non-specific alkaline phosphatase - Fc - deca-aspartate fusion protein for: Treatment of hypophosphatasia
Date of designation: 04/12/2008, Positive, Last updated: 20/11/2019alkaline phosphatase - Fc - deca-aspartate fusion protein … phosphatase - Fc - deca-aspartate fusion protein for the for … phosphatase - Fc - deca-aspartate fusion protein for the treatment … -
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Orphan designation: S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L-isoleucinamide) for: Treatment of C3 glomerulopathy
Date of designation: 17/02/2016, Positive, Last updated: 06/04/2016L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycy … L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycy … -
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Orphan designation: S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L-isoleucinamide) for: Treatment of paroxysmal nocturnal haemoglobinuria
Date of designation: 22/10/2014, Positive, Last updated: 02/10/2014L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycy … L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycy … -
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Orphan designation: N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine, folic acid for: Diagnosis of positive folate-receptor status in ovarian cancer
Date of designation: 09/02/2012, Withdrawn, Last updated: 12/11/20122-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine / folic acid … N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine and folic acid … 2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine folic acid … -
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Press release: Sanofi-Aventis withdraws marketing authorisation application for MULTAQ
Last updated: 08/09/2009Sanofi-Aventis withdraws marketing authorisation … Sanofi-Aventis withdraws marketing authorisation … EMEA/354409/2006 PRESS RELEASE Sanofi-Aventis withdraws marketing authorisation … -
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Press release: Sanofi-aventis withdraws its marketing authorisation application forAquilda (satavaptan)
Last updated: 28/05/2008Sanofi-aventis withdraws its marketing authorisation … been formally notified by sanofi-aventis of its decision to withdraw … PRESS RELEASE Sanofi-aventis withdraws its marketing authorisation … -
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Opinion/decision on a Paediatric investigation plan (PIP): L-Cysteinyl-L-prolyl-L-alanyl-L-valyl-L-lysyl-L-arginyl-L-aspartyl-L-valyl-L-aspartyl-L-leucyl-L-phenylalanyl-L-leucyl-L-threonine, acetate salt, L-glutamyl-L-glutaminyl-L-valyl-L-alanyl-Lglutaminyl-L-tyrosyl-L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanine, acetate salt, L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanyl-L-arginyl-L-isoleucyl-L-leucyl-L-lysyl-L-asparaginyl-L-cysteinyl-L-valine, acetate salt...
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001054-PIP01-10-M03, Route(s) of administration: Intradermal use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 07/08/2015, Last updated: 19/06/2017, Compliance check: XL-Cysteinyl-L-prolyl-L-alanyl-L-valyl-L-lysyl-L-arginyl-L-aspartyl-L-valyl-L aspartyl-L-leucyl-L-phenylalanyl-L-leucyl-L-threonine … L-Cysteinyl-L-prolyl-L-alanyl-L-valyl-L-lysyl-L-arginyl-L-aspartyl-L-valyl-L- aspartyl-L-leucyl-L-phenylalanyl-L-leucyl-L-threonine, hydrochloride salt / L-Glutamyl-L-glutaminyl-L- valyl-L-alanyl-L-glutaminyl-L-tyrosyl-L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L- glutamyl-L-asparaginyl-L-alanine … -
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Press release: Sanofi-aventis withdraws its marketing authorisation application for Mulsevo (semuloparin sodium)
Last updated: 09/07/2012Sanofi-aventis withdraws its marketing authorisation … been formally notified by Sanofi-aventis of its decision to withdraw … Office Press release Sanofi-aventis withdraws its marketing authorisation … -
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Press release: Sanofi-Aventis Pharma S.A. withdraws its application for an extension of indication for Taxotere and Docetaxel Winthrop (docetaxel)
Last updated: 17/11/2008Sanofi-Aventis Pharma S.A. withdraws its … been formally notified by Sanofi-Aventis Pharma S.A. of its decision … EMEA/610719/2008 PRESS RELEASE Sanofi-Aventis Pharma S.A. withdraws its … -
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Orphan designation: N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine (etarfolatide) for: Diagnosis of positive folate-receptor status in ovarian cancer
Date of designation: 10/09/2012, Withdrawn, Last updated: 07/12/20212-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine (etarfolatide … 2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine (etarfolatide) Et … -
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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 … 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 …