2658 results
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Opinion/decision on a Paediatric investigation plan (PIP): procaine (hydrochloride), xylitol, potassium chloride, magnesium sulfate heptahydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001171-PIP01-11-M02, Route(s) of administration: Intracoronary use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2021, Last updated: 31/08/2022, Compliance check: Xprocaine (hydrochloride) xylitol potassium chloride magnesium sulfate heptahydrate … paediatric investigation plan for potassium chloride) / magnesium (sulphate heptahydrate … paediatric investigation plan for potassium chloride) / magnesium (sulphate heptahydrate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP03-20-M01, Pharmaceutical form(s): Solution for organ preservation
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: Xalpha-ketoglutaric acid arginine potassium chloride magnesium chloride (hexahydrate) calcium chloride (dihydrate) sodium … alfa- ketoglutaric acid / arginine / potassium chloride / magnesium chloride (hexahydrate) / calcium … -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP01-19, Route(s) of administration: Intracoronary use, Pharmaceutical form(s): Concentrate and solvent for solution for infusion
Decision date: 09/06/2021, Last updated: 26/04/2022, Compliance check: Xalpha-ketoglutaric acid arginine potassium chloride magnesium chloride (hexahydrate) calcium chloride (dihydrate) sodium … alpha- ketoglutaric acid / arginine / potassium chloride / magnesium chloride (hexahydrate) / calcium … -
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Opinion/decision on a Paediatric investigation plan (PIP): citric acid (as citric acid anhydrous), macrogol 4000, potassium chloride, simeticone, sodium chloride, sodium citrate, sodium sulfate (as sodium sulfate anhydrous)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001356-PIP02-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 14/04/2021, Last updated: 10/03/2023, Compliance check: V, 17/12/2021anhydrous) macrogol 4000 potassium chloride simeticone sodium chloride sodium citrate sodium sulfate … for citric acid / sodium chloride / simeticone / macrogol 4000 … acid anhydrous) / sodium chloride / simeticone / macrogol 4000 … -
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Opinion/decision on a Paediatric investigation plan (PIP): alanine, arginine, aspartic acid, cysteine, cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, sodium chloride, potassium acetate, magnesium acetate tetrahydrate, calcium chloride, sodium glycerophosphate, glucose, soya bean oil, olive oil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: Alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine; sod..., Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 02/10/2009, Last updated: 07/12/2009, Compliance check: V, 16/10/2009tryptophan tyrosine valine sodium chloride potassium acetate magnesium acetate … acetate tetrahydrate calcium chloride sodium glycerophosphate glucose … tyrosine, valine, sodium chloride, potassium acetate, magnesium acetate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Medium-chain triglycerides, olive oil, Fish oil, Acetyl-cysteine, alanine, histidine, Isoleucin, leucine, Lysine acetate, methionine, phenylalanine, proline, tryptophan, tyrosine, valine, glucose, calcium chloride, potassium chloride, Sodium acetate, Zinc sulfate, Malic acid, arginine, glycine, serine, threonine, sodium glycerophosphate, soya bean oil, magnesium sulfate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Nutrition
PIP number: EMEA-002067-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Emulsion for infusion
Decision date: 07/06/2017, Last updated: 24/07/2017, Compliance check: Xtyrosine valine glucose calcium chloride potassium chloride Sodium acetate Zinc sulfate … valine / glucose / calcium chloride / sodium glycerophosphate … glycerophosphate / magnesium sulphate / potassium chloride / sodium acetate / zinc … -
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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 2, Authorised, Last updated: 30/06/2023Authorised potassium citratepotassium hydrogen … disease also causes levels of potassium in the blood to fall, which … medicine. active substances potassium citrate and … -
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 26, Authorised, Last updated: 10/07/2023Methylthioninium chloride Proveblue Hemic and Lymphatic … Authorised methylthioninium chloride Overview This is a summary … EPAR) for Methylthioninium chloride Proveblue. It explains how … -
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Human medicine European public assessment report (EPAR): Dutrebis
lamivudine, raltegravir potassium, HIV Infections
Date of authorisation: 26/03/2015, Withdrawn, Last updated: 27/04/2017lamivudine / raltegravir potassium … bis lamivudine raltegravir potassium lamivudine raltegravir potassium … -
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Withdrawn application: Raltegravir Viatris
raltegravir potassium, date of withdrawal: 22/02/2023, Initial authorisation, Last updated: 21/04/2023raltegravir potassium Overview The company Viatris … non-proprietary name: raltegravir potassium Procedure No. EMEA/H/C/005813/0000 … Viatris Raltegravir Viatris raltegravir potassium raltegravir potassium … -
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Human medicine European public assessment report (EPAR): Lumeblue (previously known as Methylthioninium chloride Cosmo)
methylthioninium chloride, Colorectal Neoplasms; Colonoscopy
Date of authorisation: 19/08/2020, Revision: 3, Authorised, Last updated: 18/09/2023known as Methylthioninium chloride Cosmo) Cancer Neoplasms Digestive … Authorised methylthioninium chloride Overview Methylthioninium chloride Cosmo is used in adults as … camera. Methylthioninium chloride Cosmo contains the The substance … -
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Human medicine European public assessment report (EPAR): Lutetium (177Lu) chloride Billev (previously Illuzyce)
lutetium (177Lu) chloride, Radionuclide Imaging
Date of authorisation: 15/09/2022, Revision: 2, Authorised, Last updated: 07/06/2023Lutetium (177Lu) chloride Billev (previously Illuzyce) Diagnostic … Authorised lutetium (177Lu) chloride Overview Lutetium ( 177 Lu chloride Billev is a solution containing … radiolabelled with Lutetium ( 177 Lu) chloride Billev, it then carries the radioactivity … -
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Human medicine European public assessment report (EPAR): Livmarli (updated)
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,
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, Revision: 3, Authorised, Last updated: 13/11/2023
Authorised Maralixibat chloride Overview Livmarli is a medicine … active substance maralixibat chloride. How is Livmarli used? Treatment … in Livmarli, maralixibat chloride, blocks the action of a protein … -
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Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor for: Treatment of cystic fibrosis
Date of designation: 14/12/2018, Positive, Last updated: 25/01/2022Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide … Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated, Potassium hydrogen carbonate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001357-PIP01-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules
Decision date: 07/12/2018, Last updated: 19/02/2019, Compliance check: V, 15/11/2019Active substance Potassium citrate monohydrated Potassium hydrogen carbonate Therapeutic … paediatric investigation plan Potassium citrate monohydrated Potassium hydrogen carbonate for treatment … Investigation Plan* (PIP) for Potassium citrate monohydrated Potassium hydrogen carbonate for treatment … -
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Human medicine European public assessment report (EPAR): Yttriga
yttrium (90Y) chloride, Radionuclide Imaging
Date of authorisation: 19/01/2006, Revision: 10, Authorised, Last updated: 29/01/2021Authorised yttrium [90Y] chloride Overview This is a summary … substance yttrium ( 90 Y) chloride. 90 Y, or yttrium-90, is a … use with yttrium ( 90 Y) chloride. The medicine can only be … -
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Human medicine European public assessment report (EPAR): Ytracis
yttrium (90Y) chloride, Radionuclide Imaging
Date of authorisation: 24/03/2003, Revision: 7, Withdrawn, Last updated: 19/01/2022Withdrawn yttrium [90Y] chloride Overview The marketing authorisation … gt;YtracisEMEA/H/C/000460yttrium (90Y) chlorideyttrium [90Y chlorideRadionuclide ImagingV09 Publication details … for Ytracis (yttrium (90Y) chloride) in the European Union (EU … -
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Human medicine European public assessment report (EPAR): Theryttrex
yttrium (90Y) chloride, Radionuclide Imaging
Date of authorisation: 07/01/2003, Revision: 1, Withdrawn, Last updated: 02/03/2006Withdrawn yttrium [90Y] chloride Overview The marketing authorisation … gt;TheryttrexEMEA/H/C/000445yttrium (90Y) chlorideyttrium [90Y chlorideRadionuclide ImagingV09 Publication details … THERYTTREX (Yttrium(90Y) Chloride) WITHDRAWAL OF THE MARKETING … -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of Alagille syndrome
Date of designation: 18/12/2013, Positive, Last updated: 14/12/2022tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) … tetrahydro-4- hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4- aza-1-azoniabicyclo[2.2.2]octane chloride for the treatment of Alagille … -
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Opinion/decision on a Paediatric investigation plan (PIP): Livmarli, Maralixibat chloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001475-PIP03-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 28/10/2022, Last updated: 05/10/2023, Compliance check: XActive substance Maralixibat chloride Therapeutic area Gastroentology-Hepatology … investigation plan for maralixibat chloride (EMEA-001475-PIP03-17-M03 … investigation plan for maralixibat chloride (EMEA-001475-PIP03-17-M03 … -
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Human medicine European public assessment report (EPAR): Cuprymina
copper (64Cu) chloride, Radionuclide Imaging
Date of authorisation: 23/08/2012, Revision: 8, Authorised, Last updated: 01/07/2022copper (64Cu) chloride … Cuprymina, INN-copper (64Cu) chloride 7 Westferry Circus … Cuprymina copper (64Cu) chloride This is a summary of the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated, potassium hydrogen carbonate (ADV7103)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001535-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: XKey facts Potassium citrate monohydrated potassium hydrogen carbonate (ADV7103 … paediatric investigation plan for potassium citrate monohydrated potassium hydrogen carbonate (ADV7103 … paediatric investigation plan Potassium citrate monohydrated potassium hydrogen carbonate for Treatment … -
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Human medicine European public assessment report (EPAR): EndolucinBeta
lutetium (177Lu) chloride, Radionuclide Imaging
Date of authorisation: 06/07/2016, Revision: 8, Authorised, Last updated: 16/02/2021Authorised lutetium (177 Lu) chloride Overview EndolucinBeta contains … compound lutetium ( 177 Lu) chloride and is used for radiolabelling … use with lutetium ( 177 Lu) chloride. How is EndolucinBeta used … -
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Human medicine European public assessment report (EPAR): Lumark
lutetium (177Lu) chloride, Radionuclide Imaging
Date of authorisation: 18/06/2015, Revision: 9, Authorised, Last updated: 29/09/2020Authorised lutetium (177 Lu) chloride Overview Lumark contains … compound lutetium ( 177 Lu) chloride and is used for radiolabelling … use with lutetium ( 177 Lu) chloride. How is Lumark used? Lumark … -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 16/01/2014, Positive, Last updated: 03/12/2021tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) … tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride for the treatment of progressive …