1617 results
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Human medicine European public assessment report (EPAR): Eurartesim
piperaquine tetraphosphate, Artenimol, Malaria
Date of authorisation: 27/10/2011, Revision: 12, Authorised, Last updated: 01/09/2021piperaquine tetraphosphate / artenimol … Eurartesim piperaquine tetraphosphate / artenimol This is a … active substances piperaquine tetraphosphate and artenimol. It is available … -
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Orphan designation: 4-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl for: Treatment of familial cerebral cavernous malformations
Date of designation: 12/12/2017, Positive, Last updated: 11/10/20224-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl … designation 4-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl for the treatment … designation 4-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl for the treatment … -
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Human medicine European public assessment report (EPAR): Pluvicto
lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022,
, Revision: 2, Authorised, Last updated: 19/04/2023
lutetium (177Lu) vipivotide tetraxetan Overview Pluvicto is a medicine … lutetium ( 177 Lu) vipivotide tetraxetan. How is Pluvicto used? Because … lutetium (177Lu) vipivotide tetraxetan) An overview of Pluvicto … -
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Orphan designation: 4-Amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride for: Treatment of moderate and severe traumatic brain injury
Date of designation: 28/08/2006, Positive, Last updated: 28/05/20114-Amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride … 4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride for the moderate … for 4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride for the … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 10/08/2015, Positive, Last updated: 27/03/2023S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … designation (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … designation (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2- carboxamide … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of Leigh syndrome
Date of designation: 15/10/2014, Positive, Last updated: 27/03/2023S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … designation (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … designation (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2- carboxamide … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of maternally-inherited diabetes and deafness
Date of designation: 28/06/2019, Positive, Last updated: 27/03/2023S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide … S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide … -
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Orphan designation: 1-(2-isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one (verdiperstat) for: Treatment of multiple system atrophy
Date of designation: 16/12/2014, Positive, Last updated: 21/09/20211-(2-isopropoxyethyl)-2-thioxo-1,2,3,5- tetrahydro-pyrrolo[3,2-d]pyrimidin-4-one Treatment of multiple system … 1-(2-isopropoxyethyl)-2-thioxo-1,2,3,5- tetrahydro-pyrolo[3,2-d]pyrimidin-4-on Léčba multisystémové … -
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Orphan designation: S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid for: Treatment of primary sclerosing cholangitis
Date of designation: 16/10/2017, Positive, Last updated: 08/01/2018ropanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid … S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid for the treatment of … S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)- 4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid for the treatment … -
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Orphan designation: Human interleukin-2 (glycosylated tetrasaccharide, glycosylated trisaccharide and non-glycosylated) for: Treatment of renal-cell carcinoma
Date of designation: 27/10/2006, Positive, Last updated: 11/04/2016interleukin-2 (glycosylated tetrasaccharide, glycosylated trisaccharide … interleukin-2 (glycosylated tetrasaccharide, glycosylated trisaccharide … interleukin-2 (glycosylated tetrasaccharide, glycosylated trisaccharide … -
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Orphan designation: (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate for: Treatment of amyotrophic lateral sclerosis
Date of designation: 27/02/2009, Positive, Last updated: 19/05/20116R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine … designation (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine … Kingdom, for (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6- benzothiazolediamine … -
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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: 27/08/202014-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 … 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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Human medicine European public assessment report (EPAR): Cuprior
Trientine tetrahydrochloride, Hepatolenticular Degeneration
Date of authorisation: 05/09/2017, Revision: 6, Authorised, Last updated: 20/02/2023form of trientine (trientine tetrahydrochloride) and does not need to be stored … Cuprior, INN-Trientine tetrahydrochloride 30 Churchill Place … form of trientine (trientine tetrahydrochloride) and does not need to be stored … -
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Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid for: Treatment of systemic sclerosis
Date of designation: 12/01/2017, Positive, Last updated: 11/08/202010aR)-3-(1',1'-dimethylheptyl)-delta-8- tetrahydro-cannabinol-9-carboxylic acid (also known as JBT-101 … 10aR)-3-(1',1'-dimethylheptyl)-delta-8- tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic … 6aR,10aR)-3-(1',1'-dimetilheptil)-delta-8- tetrahidro-kanabinol-9-karboksilna kiselina Liječenje sistemske … -
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Orphan designation: 2,3,4,5 Tetrahydro-2,8-dimethyl-5-[2-(6-methyl-3-pyridinyl)ethyl]-1H-pyrido[4,3-b]indole dihydrochloride for: Treatment of Huntington’s disease
Date of designation: 21/01/2009, Withdrawn, Last updated: 08/05/20152,3,4,5 Tetrahydro-2,8-dimethyl-5-[2-(6-methyl-3-pyridinyl)ethyl]-1H-pyrido[4,3-b]indole dihydrochloride … orphan designation 2,3,4,5 tetrahydro-2,8-dimethyl-5-[2-(6-methyl-3-pyridinyl)ethyl]-1H- pyrido[4,3-b]indole dihydrochloride … United Kingdom, for 2,3,4,5 tetrahydro-2,8-dimethyl-5- [2-(6-methyl-3-pyridinyl)ethyl]-1H-pyrido[4,3-b]indole … -
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Referral: Tetrazepam-containing medicines
tetrazepam, associated names: Myolastan and generics, Article 107i procedures
Status: European Commission final decision, opinion/position date: 24/04/2013, EC decision date: 29/05/2013, Last updated: 18/07/2013Tetrazepam-containing medicines … Tetrazepam-containing medicines suspended across … recommends suspension of tetrazepam-containing medicines Recommendation … -
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Opinion/decision on a Paediatric investigation plan (PIP): (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride (KH176) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002113-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: Xsubstance (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … for (S)-6-hydroxy- 2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … for (S)-6-hydroxy- 2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Eurartesim, Artenimol, piperaquine phosphate anhydride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000153-PIP01-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 04/01/2018, Last updated: 17/04/2018, Compliance check: V, 26/01/2018sim Eurartesim piperaquine tetraphosphate artenimol Artenimol piperaquine … phosphate anhydride piperaquine tetraphosphate Artenimol … -
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Orphan designation: Tetrahydrobiopterin for: Treatment of hyperphenylalaninaemia
Date of designation: 08/06/2004, Withdrawn, Last updated: 11/01/2021Tetrahydrobiopterin … opinion on orphan designation Tetrahydrobiopterin for the treatment of hyperphenylalaninemia … Gertrud Thormann, France, for tetrahydrobiopterin for the treatment of hyperphenylalaninemia … -
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Orphan designation: Trientine tetrahydrochloride for: Treatment of Wilson's disease
Date of designation: 19/03/2015, Withdrawn,Trientine tetrahydrochloride … orphan designation Trientine tetrahydrochloride for the treatment of Wilson's … orphan designation Trientine tetrahydrochloride for the treatment of Wilson's … -
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Orphan designation: Choline tetrathiomolybdate for: Treatment of Wilson's disease
Date of designation: 24/01/2013, Positive, Last updated: 20/11/2019Choline tetrathiomolybdate … orphan designation Choline tetrathiomolybdate for the treatment of Wilson’s … orphan designation Choline tetrathiomolybdate for the treatment of Wilson’s … -
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Orphan designation: Decitabine, tetrahydrouridine for: Treatment of sickle cell disease
Date of designation: 20/06/2017, Positive, Last updated: 17/07/2017Decitabine / tetrahydrouridine … designation Decitabine and tetrahydrouridine for the treatment of sickle … designation Decitabine and tetrahydrouridine for the treatment of sickle … -
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Orphan designation: Denufosol tetrasodium for: Treatment of cystic fibrosis
Date of designation: 23/12/2005, Withdrawn, Last updated: 21/10/2016Denufosol tetrasodium … designation designation Denufosol tetrasodium for the treatment of cystic … orphan designation Denufosol tetrasodium for the treatment of cystic … -
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Orphan designation: Ammonium tetrathiomolybdate for: Treatment of Wilson's disease
Date of designation: 01/04/2008, Positive, Last updated: 10/07/2008Ammonium tetrathiomolybdate … ammonium tetrathiomolybdate for the treatment of Wilson’s … DESIGNATION OF ammonium tetrathiomolybdate for the treatment of Wilson’s … -
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Orphan designation: 5,6,7,8-Tetrahydrobiopterin for: Treatment of hyperphenylalaninaemia
Date of designation: 02/10/2003, Positive, Last updated: 23/02/20075,6,7,8-Tetrahydrobiopterin … 5,6,7,8 tetrahydrobiopterin for the treatment of hyperphenylalaninemia … DESIGNATION OF 5,6,7,8 tetrahydrobiopterin for the treatment of hyperphenylalaninemia …