2380 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-M01, Route(s) of administration: Intracoronary use, Pharmaceutical form(s): Solution for injection
Decision date: 04/11/2016, Last updated: 19/01/2017, Compliance check: Xprocaine (hydrochloride) xylitol potassium chloride magnesium sulfate heptahydrate … paediatric investigation plan for potassium chloride) / magnesium (sulphate heptahydrate … paediatric investigation plan for potassium 30 Churchill Place ● … -
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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: 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-PIP03-20, Route(s) of administration: Not applicable, Pharmaceutical form(s): Solution for organ preservation
Decision date: 10/05/2021, Last updated: 14/02/2022, 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): 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: 18/01/2022, Compliance check: Xanhydrous) macrogol 4000 potassium chloride simeticone sodium chloride sodium citrate sodium sulfate … acid anhydrous) / sodium chloride / simeticone / macrogol 4000 … sodium sulfate anhydrous) / potassium chloride (Clensia), (EMEA-001356-PIP02-12-M04 … -
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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: 1, Authorised, Last updated: 26/04/2022Authorised 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: 23, Authorised, Last updated: 10/09/2021Methylthioninium 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: 27/04/2017hdrawn lamivudineraltegravir potassium Overview The marketing authorisation … gt;DutrebisEMEA/H/C/003823lamivudineraltegravir potassiumlamivudineraltegravir potassiumHIV InfectionsJ05AR16 Publication … bis lamivudine raltegravir potassium lamivudine 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: 2, Authorised, Last updated: 16/06/2021known as Methylthioninium chloride Cosmo) Cancer Neoplasms Digestive … known as Methylthioninium chloride Cosmo … Lumeblue (methylthioninium chloride)1 An overview of Lumeblue … -
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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): 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): 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: 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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Human medicine European public assessment report (EPAR): Cuprymina
copper (64Cu) chloride, Radionuclide Imaging
Date of authorisation: 23/08/2012, Revision: 7, Authorised, Last updated: 24/03/2020Authorised copper (64Cu) chloride Overview This is a summary … substance copper ( 64 Cu) chloride. 64 Cu is a radioactive form … use with copper ( 64 Cu) chloride. Medicines to be radiolabelled … -
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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): 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 … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): (2S,4S)-2-(4-Carboxyphenyl)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-1-ium chloride―water (1/1) (LNP023)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002705-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 23/10/2020, Last updated: 28/07/2021, Compliance check: X2S,4S)-2-(4-Carboxyphenyl)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-1-ium chloride―water (1/1) (LNP023) OtherP/0417/2020EMEA-002705-PIP01-19 … 2S,4S)-2-(4-Carboxyphenyl)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4- yl)methyl]piperidin-1-ium chloride―water (1/1) (LNP023) (EMEA-002705-PIP01-19 … -
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Opinion/decision on a Paediatric investigation plan (PIP): (2S,4S)-2-(4-Carboxyphenyl)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-1-ium chloride―water (1/1) (LNP023)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002705-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Capsule, hard
Decision date: 23/10/2020, Last updated: 04/08/2021, Compliance check: X2S,4S)-2-(4-Carboxyphenyl)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-1-ium chloride―water (1/1) (LNP023) OtherP/0415/2020EMEA-002705-PIP02-19 … 2S,4S)-2-(4-Carboxyphenyl)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4- yl)methyl]piperidin-1-ium chloride―water (1/1) (LNP023) (EMEA-002705-PIP02-19 … -
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Human medicine European public assessment report (EPAR): Tookad
padeliporfin di-potassium, Prostatic Neoplasms
Date of authorisation: 10/11/2017,
, Revision: 4, Authorised, Last updated: 02/03/2022
substance padeliporfin di-potassium International non-proprietary … adeliporfin padeliporfin di-potassium … -
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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 … waiver for Gallium [68 Ga] Chloride / Germanium [68 Ge Chloride (EMEA-001102-PIP01-10) PDF … waiver for Gallium [68 Ga] Chloride / Germanium [68 Ge Chloride (EMEA-001102-PIP01-10) in … -
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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 … waiver for Germanium (68Ge) chloride / Gallium (68Ga chloride (EMEA-002436-PIP01-18) PDF … germanium (68Ge) chloride gallium (68Ga chloride …