16932 results
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Opinion/decision on a Paediatric investigation plan (PIP): gallium (68Ga) chloride, germanium (68Ge) chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001102-PIP01-10, Route(s) of administration: Other use, Pharmaceutical form(s): Radionuclide generator
Decision date: 08/06/2011, Last updated: 14/07/2011, Compliance check: XKey facts gallium (68Ga) chloride germanium 68Ge) chloride OtherP/133/2011EMEA-001102-PIP01-10 … product specific waiver for Gallium 68 Ga] Chloride Germanium … gallium (68Ga) chloride germanium 68Ge) chloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): germanium (68Ge) chloride, gallium (68Ga) chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002436-PIP01-18, Pharmaceutical form(s): Radionuclide generator
Decision date: 03/01/2019, Last updated: 24/04/2019, Compliance check: XKey facts germanium 68Ge) chloride gallium (68Ga) chloride OtherP/0019/2019EMEA-002436-PIP01-18 … germanium 68Ge) chloride gallium (68Ga) chloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): Gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic; Oncology
PIP number: EMEA-002577-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: XKey facts Gallium 68-labelled Prostate-Specific Membrane … Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11) DiagnosticOncologyP/0290/2019EMEA-002577-PIP01-19 … product specific waiver for gallium … -
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Orphan designation: Gallium (68Ga)-pasireotide tetraxetan for: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 27/10/2011, Positive, Last updated: 23/11/2011Gallium (68Ga)-pasireotide tetraxetan Overview On 27 … OctreoPharm Sciences GmbH, Germany, for gallium 68 … opinion on orphan designation Gallium (68Ga)-pasireotide tetraxetan for the diagnosis … -
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Opinion/decision on a Paediatric investigation plan (PIP): Gallium (68Ga)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001842-PIP02-15, Route(s) of administration: Parenteral use, Pharmaceutical form(s): Radiopharmaceutical precursor, Solution
Decision date: 15/04/2016, Last updated: 02/06/2016, Compliance check: XKey facts Gallium (68Ga) OtherP/0110/2016EMEA-001842-PIP02-15 … product specific waiver for Gallium 68Ga] (EMEA-001842-PIP02-15) PDF … 02/06/2016 EMA/188353/2016 Generic Topics: Paediatrics … -
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Orphan designation: Gallium (68Ga)-edotreotide for: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 19/03/2015, Positive, Last updated: 20/02/2017Gallium (68Ga)-edotreotide … opinion on orphan designation Gallium (68Ga)-edotreotide for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours … TOC SomaKit TOC edotreotide Gallium (68Ga)-edotreotide edotreotide … -
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Orphan designation: Adeno-associated virus serotype hu68 containing the human GALC gene for: Treatment of Krabbe disease
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022associated virus serotype hu68 containing the human GALC gene Overview This medicine was … the medicine is unlikely to generate sufficient profit to justify … adeno-associated virus serotype hu68 containing the human GALC gene - EMA/OD/0000046077 … -
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Orphan designation: 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2 for: Diagnosis of gastrointestinal stromal tumours
Date of designation: 12/12/2016, Positive,68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2 Overview On 12 December 2016 … Applications, France, for 68 Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH 2 -CH(CH 3 ) 2 ] 2 (also … opinion on orphan designation 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2 for the diagnosis of gastrointestinal stromal tumours 30 … -
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Orphan designation: Lys40(NODAGA-68Ga)NH2-exendin-4 for: Diagnosis of insulinoma
Date of designation: 26/06/2020, Positive, Last updated: 24/09/2020Netherlands, for Lys40(NODAGA-68Ga)NH2-exendin-4 for the diagnosis … of a radioactive element, gallium (68Ga), attached to a derivative … The effects of Lys40(NODAGA-68Ga)NH2-exendin-4 have been evaluated … -
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Orphan designation: Adeno-associated virus serotype hu68 containing the human GLB1 gene for: Treatment of GM1 gangliosidosis
Date of designation: 19/10/2020, Positive, Last updated: 16/02/2021associated virus serotype hu68 containing the human GLB1 gene Overview On 19 October 2020 … European Commission to Pharma Gateway AB, Sweden, for adeno-associated … adeno-associated virus serotype hu68 containing the human GLB1 … -
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Orphan designation: Gallium [Ga-68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic(2-7)disulfide for: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 19/02/2014, Positive,Gallium Ga 68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic(2-7)disulfide … opinion on orphan designation Gallium Ga 68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic(2-7)disulfide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor (CAR) for B-cell maturation antigen (BCMA) (JNJ-68284528)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002585-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 04/10/2019, Last updated: 25/03/2020, Compliance check: XAutologous human T cells genetically modified ex-vivo with a lentiviral … maturation antigen (BCMA) (JNJ-68284528) OncologyP/0353/2019EMEA-002585-PIP01-19 … autologous human T cells genetically modified ex-vivo with a lentiviral … -
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Orphan designation: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine for: Treatment of neurotrophic keratitis
Date of designation: 16/12/2014, Positive, Last updated: 08/06/20184R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic … 1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic … 1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001886-PIP02-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 11/08/2017, Last updated: 02/10/2017, Compliance check: Xwith Albumin (rVIIa-FP; CSL689) Haematology-HemostaseologyP/0223/2017EMEA-001886-PIP02-15-M01 … with Albumin (rVIIa-FP; CSL689) (... PDF icon application/pdf … 02/10/2017 EMA/460047/2017 Generic Topics: Paediatrics … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001886-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 09/08/2017, Last updated: 02/10/2017, Compliance check: Xwith Albumin (rVIIa-FP; CSL689) Haematology-HemostaseologyP/0207/2017EMEA-001886-PIP01-15-M01 … with Albumin (rVIIa-FP; CSL689) (E... PDF icon application/pdf … 02/10/2017 EMA/466902/2017 Generic Topics: Paediatrics … -
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Core summary of product characteristics and package leaflet for (68Ge/68Ga) generator - Scientific guideline
Last updated: 08/09/2017and package leaflet for (68Ge/68Ga generator - Scientific guideline … owners. package leaflet for (68Ge/68Ga generator. … and Package Leaflet for (68Ge/68Ga generator Draft agreed by Radiopharmaceutical …
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Orphan designation: 2-((3-((4-((3-aminopropyl)amino)butyl)amino)propyl)amino)-N-((5S,5aS,8aR,9R)-9-(4-hydroxy-3,5-dimethoxyphenyl)-8-oxo-5,5a,6,8,8a,9-hexahydrofuro[3',4':6,7]naphtho[2,3-d][1,3]dioxol-5-yl)acetamide, tetrahydrochloride for: Treatment of acute myeloid leukaemia
Date of designation: 28/07/2015, Positive, Last updated: 18/08/2015dimethoxyphenyl)-8-oxo-5,5a,6,8,8a,9-hexahydrofuro[3',4':6,7]naphtho[2,3-d][1,3]dioxol-5-yl)acetamide … 2-((3-((4-((3-aminopropyl)amino)butyl)amino)propyl)amino)-N-((5S,5aS,8aR,9R)-9-(4-hydroxy-3,5-dimethoxyphenyl)-8-oxo-5,5a,6,8,8a,9-hexahydrofuro[3',4':6,7]naphtho[2,3-d][1,3]dioxol-5-yl)acetamide … -
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Orphan designation: Cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl}-L-2-aminobutyryl-N-methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl} for: Treatment of chronic non-infectious uveitis
Date of designation: 14/09/2007, Withdrawn, Last updated: 17/10/2013{{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl}-L-2-aminobutyryl-N-methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl} … to Lux Biosciences GmbH, Germany, for cyclo {{(E,Z)-(2S,3R,4R … -
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Orphan designation: 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan-2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic acid (satoreotide trixozetan) for: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 19/02/2014, Positive, Last updated: 09/02/2022Germany in February 2022. What are gastro-entero-pancreatic neuroendocrine tumours Gastro-entero-pancreatic neuroendocrine tumours … opinion on orphan designation 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1- oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4- carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)- 1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan- 2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic … -
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Human medicine European public assessment report (EPAR): Ganirelix Gedeon Richter
ganirelix acetate, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 15/07/2022,
, Authorised, Last updated: 20/07/2022
Ganirelix Gedeon Richter Reproductive Techniques Therapeutics Investigative … Techniques Reproductive Techniques, Assisted Genital Diseases, Female Female … Authorised ganirelix Overview Ganirelix Gedeon Richter is a medicine used … -
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Orphan designation: Adeno-associated viral vector containing the human gamma-sarcoglycan gene for: Treatment of gamma sarcoglycanopathy
Date of designation: 21/10/2004, Withdrawn, Last updated: 18/06/2014vector containing the human gamma-sarcoglycan gene Overview Please note that … vector containing the human gamma sarcoglycan gene for the treatment of … vector containing the human gamma sarcoglycan gene for the treatment of gamma sarcoglycanopathy … -
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Orphan designation: Adeno-associated virus serotype 8 expressing the human gamma-sarcoglycan gene for: Treatment of limb-girdle muscular dystrophy
Date of designation: 16/05/2022, Positive, Last updated: 14/12/2022serotype 8 expressing the human gamma-sarcoglycan gene Overview This medicine was … the medicine is unlikely to generate sufficient profit to justify … the medicine is unlikely to generate sufficient profit to justify … -
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Orphan designation: Autologous CD34+ cells transduced ex vivo with a lentiviral vector containing a modified gamma-globin gene for: Treatment of sickle cell disease
Date of designation: 13/11/2020, Withdrawn, Last updated: 16/09/2022vector containing a modified gamma-globin gene Overview On 13 November 2020 … vector containing a modified gamma-globin gene (also known as ARU-1801 … vector containing a modified gamma-globin gene for the treatment of sickle … -
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Orphan designation: (1R, 2R, 4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R, 27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,2 for: Treatment of soft tissue sarcoma
Date of designation: 26/08/2005, Withdrawn, Last updated: 11/03/201327R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,2 … to Orphix Consulting GmbH, Germany, for (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R … 1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentao … -
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Orphan designation: (1R, 2R, 4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R, 27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,2 for: Treatment of primary malignant bone tumours
Date of designation: 28/10/2005, Withdrawn, Last updated: 11/03/201327R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,2 … to Orphix Consulting GmbH, Germany, for (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R … 12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34 …