14031 results
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Human medicine European public assessment report (EPAR): Ixiaro
Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese; Immunization
Date of authorisation: 31/03/2009, Revision: 17, Authorised, Last updated: 12/04/2021PDF/82.88 KB) Greek (PDF/120.14 KB) (PDF/120 14 KB) Hungarian (PDF/103.51 … Canary Wharf ● London E14 4HB ● United Kingdom Telephone … Canary Wharf ● London E14 4HB ● United Kingdom Telephone … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ixiaro, Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000559-PIP01-09-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 04/10/2017, Last updated: 02/03/2018, Compliance check: V, 10/11/2017inactivated (attenuated strain SA14-14-2 grown in vero cells) Therapeutic … Canary Wharf ● London E14 5EU ● United Kingdom An … Canary Wharf ● London E14 5EU ● United Kingdom An … -
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Orphan designation: 1,4-diamino-2,3-dicyano-1,4-bis[2-aminophenylthio] butadiene for: Treatment of non-traumatic subarachnoid haemorrhage
Date of designation: 12/10/2017, Positive, Last updated: 15/01/20181,4-diamino-2,3-dicyano-1,4-bis[2-aminophenylthio] butadiene … to Edvince AB, Sweden, for 1,4-diamino-2,3-dicyano-1,4-bis[2-aminophenylthio]butadiene … accordance with Regulation (EC) No 141/2000 of 16 December 1999, the … -
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Orphan designation: Purified inactivated Japanese encephalitis SA14-4-2 virus vaccine for: Prevention of Japanese encephalitis
Date of designation: 24/01/2006, Withdrawn,inactivated Japanese encephalitis SA14-4-2 virus vaccine Overview Please … inactivated Japanese encephalitis SA14-4-2 virus vaccine for the prevention … the Japanese encephalitis SA14-4-2 virus, which causes an inflammation … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous tumour-infiltrating lymphocytes (LN-144/LN-145) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002776-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: Xtumour-infiltrating lymphocytes (LN-144/LN-145) OncologyP/0363/2021EMEA-002776-PIP01-20-M01 … tumourinfiltrating lymphocytes (LN-144/LN-145) (EMEA-002776-PIP01-20-M01 … tumour- infiltrating lymphocytes (LN-144/LN-145) (EMEA-002776-PIP01-20-M01 … -
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Orphan designation: (S)-10-[(dimethylamino)methyl]-4-ethyl-9-hydroxy-4-O-[alpha-(2", 4", 5", 7"-tetranitro-9"-fluorenylideneaminooxy)propionyl]-1H-pyrano[3', 4', 6', 7']indolizino[1,2-beta]-quinoline-3, 14-(4H, 12H)-dione, hydrochloride for: Treatment of hepatocellular carcinoma
Date of designation: 01/10/2010, Positive, Last updated: 14/10/20107']indolizino[1,2-beta]-quinoline-3, 14-(4H, 12H)-dione, hydrochloride … 7']indolizino[1,2-beta]-quinoline-3, 14-(4 H , 12 H )-dione, hydrochloride … accordance with Regulation (EC) No 141/2000 of 16 December 1999, the … -
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Opinion/decision on a Paediatric investigation plan (PIP): (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-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: P/2/2010, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Gastro-resistant tablet, Age-appropriate dosage form, other, Age-appropriate dosage form for parenteral use
Decision date: 25/01/2010, Last updated: 25/02/2010, Compliance check: X1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy … roxy- 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 … aoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-001314-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Decision date: 07/04/2014, Last updated: 12/01/2021, Compliance check: XGD2) monoclonal antibody (ch14.18/CHO) (APN311) OncologyP/0094/2014EMEA-001314-PIP01-12 … GD2) monoclonal antibody (ch14.18/CHO) (APN311) PDF icon application/pdf … GD2) monoclonal antibody (ch14.18/CHO) (APN311) 7 Westferry … -
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Opinion/decision on a Paediatric investigation plan (PIP): (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl- 3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4- f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide (AMG 176)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002631-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 24/08/2020, Last updated: 24/06/2021, Compliance check: XKey facts (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl- 3',4',7a,8,9,9a,10 … ethyl- 3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4 … waiver for (4S,7aR,9aR,10S,11E,14S,15R)....(EMEA-002631-PIP01-19 … -
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Orphan designation: (S)-12-fluoro-4-(2-methylpyridin-3-yl)-7a,8,13,14-tetrahydro-7H-[1,2,4]triazolo[4',3':1,6]pyrido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine for: Treatment of sickle cell disease
Date of designation: 16/03/2022, Positive, Last updated: 16/06/2022methylpyridin-3-yl)-7a,8,13,14-tetrahydro-7H-[1,2,4]triazolo … rido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine Overview This medicine … S)-12-fluoro-4-(2-methylpyridin-3-yl)-7a,8,13,14-tetrahydro-7H- [1,2,4]triazol … -
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Orphan designation: (2-aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxy benzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosu (pasireotide) for: Treatment of functional gastro-entero-pancreatic endocrine tumours
Date of designation: 08/06/2004, Withdrawn, Last updated: 16/08/2017carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxy … enzyl-8-(4-benzyloxy benzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl … carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxy … -
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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: 09/02/2022EU/3/14/1246 … 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1 … idobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-yla … -
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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: 11/03/20134S)-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 … methyl-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 … -
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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: 11/03/20134S)-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 … methyl-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 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Icosasodium{26-[(2-acetamido-2-deoxy-β-D-galactopyranosyl)oxy]-14,14-bis{[(3-{6-[(2-acetamido-2-deoxy-β-D-galactopyranosyl)oxy]hexyl}amino)-3-oxopropoxy)]methyl}-8,12,19-trioxo-16-oxa-7,13,20-triazahexacosyl}2′-O-(2-methoxyethyl...
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002786-PIP01-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/07/2020, Last updated: 17/06/2021, Compliance check: XIcosasodium{26-[(2-acetamido-2-deoxy-β-D-galactopyranosyl)oxy]-14,14-bis{[(3-{6-[(2-acetamido-2-deoxy-β-D-galactopyranosyl)oxy]hexyl}amino)-3-oxopropoxy)]methyl}-8,12,19-trioxo-16-oxa-7,13,20-triazahexacosyl}2′-O-(2-methoxyethyl … icosasodium{26-[(2-acetamido-2-deoxy-β-Dgalactopyranosyl) oxy]-14,14-bis{[(3-{6-[(2-acetamido-2-deoxy-β-Dgalactopyranosyl … -
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Orphan designation: (16E)-14-methyl-20-oxa-5,7,14,26-tetraaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene–citric acid for: Treatment of glioma
Date of designation: 17/10/2019, Positive, Last updated: 27/08/202016E)-14-methyl-20-oxa-5,7 14,26-tetraaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene–citric … B.V., Netherlands, for (16E)-14-methyl-20-oxa-5,7 14,26-tetraaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8(27),9,11,16,21,23-decaene–citric … -
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Orphan designation: [Ala1,3,12,Gln10,Arg11,Trp14]PTH(1-14)/[Ala18,22, Lys26]PTHrP(15-36)COOH for: Treatment of hypoparathyroidism
Date of designation: 24/02/2022, Positive, Last updated: 29/04/2022Ala1,3,12,Gln10,Arg11,Trp14]PTH(1-14)/[Ala18,22, Lys26]PTHrP(15-36)COOH … Ala1,3,12,Gln10,Arg11,Trp14]PTH(1-14)/[Ala18,22, Lys26]PTHrP(15-36)COOHTreatment … Ala1,3,12,Gln10,Arg11,Trp14]PTH(1-14)/[Ala18,22, Lys26]PTHrP(15-36)COOH … -
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), Chicken
Date of authorisation: 01/09/2006,
, Revision: 8, Authorised, Last updated: 25/03/2021
which may last for about 14 days. What are the precautions … Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 … which may last for about 14 days. What are the precautions … -
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Orphan designation: Peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN) for: Treatment of localised scleroderma
Date of designation: 28/10/2005, Positive, Last updated: 23/06/2010Peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN … S.L., Spain, for peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN … drug designation. Peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN … -
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Orphan designation: Peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN) for: Treatment of systemic sclerosis
Date of designation: 28/10/2005, Positive, Last updated: 23/06/2010Peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN … S.L., Spain, for peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN … drug designation. Peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN … -
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Orphan designation: Anti-CD 147 murine monoclonal IgM for: Treatment of steroid resistant graft versus host disease (GvHD)
Date of designation: 14/11/2002, Withdrawn, Last updated: 07/07/2003Anti-CD 147 murine monoclonal IgM Overview … request of the sponsor. On 14 November 2002, orphan designation … United Kingdom, for anti-CD147 murine monoclonal IgM for … -
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Orphan designation: 1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3-fluorophenyl)ethan-1-one for: Treatment of propionic acidaemia
Date of designation: 19/07/2021, Positive, Last updated: 05/09/20221-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3-fluorophenyl)ethan-1-one … 1-(4-(6-chloropyridazin-3-yl)piperazi … -
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Orphan designation: 1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3-fluorophenyl)ethan-1-one for: Treatment of pantothenate kinase-associated neurodegeneration
Date of designation: 19/07/2021, Positive, Last updated: 05/09/20221-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3-fluorophenyl)ethan-1-one … 1-(4-(6-chloropyridazin-3-yl)piperazi … -
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Orphan designation: 1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride for: Treatment of tularaemia
Date of designation: 24/04/2015, Positive, Last updated: 21/05/2015EU/3/15/1476 … 1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride … orphan designation (EU/3/15/1476) was granted by the European … -
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Orphan designation: 1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride for: Treatment of cryptococcosis
Date of designation: 24/04/2015, Positive, Last updated: 21/05/2015EU/3/15/1475 … 1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride … orphan designation (EU/3/15/1475) was granted by the European …