2136 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): 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): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 22, Authorised, Last updated: 10/03/2020Methylthioninium chloride Proveblue Methemoglobinemia … 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): Sibnayal (new)
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Authorised, Last updated: 03/05/2021potassium citrate potassium hydrogen carbonate … EMEA/H/C/005407 Sibnayal (potassium citrate potassium hydrogen carbonate) An … disease also causes levels of potassium in the blood to fall, which … -
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Cosmo
methylthioninium chloride, Colorectal Neoplasms, Colonoscopy
Date of authorisation: 19/08/2020, Authorised, Last updated: 26/08/2020Methylthioninium chloride Cosmo Colorectal Neoplasms … Methylthioninium chloride Cosmo … Methylthioninium chloride Cosmo methylthioninium chloride methylthioninium chloride … -
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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): 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, Authorised, Last updated: 10/07/2015Authorised yttrium [90Y] chloride Overview This is a summary … substance yttrium ( 90 Y) chloride. 90 Y, yttrium-90, is a radioactive … ingredient yttrium ( 90 Y) chloride. These medicines act as carrier … -
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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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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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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: 29/09/2020lutetium (177 Lu) chloride … Lumark lutetium (177 Lu) chloride lutetium (177Lu chloride … -
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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: XKey facts Potassium citrate monohydrated Potassium hydrogen carbonate Uro-nephrologyP/0355/2018EMEA-001357-PIP01-12-M02 … paediatric investigation plan for potassium citrate monohydrated potassium hydrogen carbonate (EMEA-001357-PIP01-12-M02 … -
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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): 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 … -
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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 first decision: 16/01/2014, Positive, Last updated: 04/05/2020now known as maralixibat chloride. On 16 January 2014, orphan … 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 … tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat … -
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Human medicine European public assessment report (EPAR): Tookad
padeliporfin di-potassium, Prostatic Neoplasms
Date of authorisation: 10/11/2017,
, Revision: 2, Authorised, Last updated: 01/02/2021
substance padeliporfin di-potassium International non-proprietary … adeliporfin padeliporfin di-potassium … -
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Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350, sodium sulfate, sodium chloride, sodium ascorbate, potassium chloride (NER1006), Ascorbic acid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001705-PIP02-15-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Powder for oral solution
Decision date: 19/05/2019, Last updated: 30/10/2019, Compliance check: X3350 sodium sulfate sodium chloride sodium ascorbate potassium chloride (NER1006) Ascorbic acid Gastroentology-HepatologyP/0196/2019EMEA-001705-PIP02-15-M02 … 3350 sodium sulfate sodium chloride sodium ascorbate Ascorbic … -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium
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: Losartan potassium, Route(s) of administration: Oral route, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 29/02/2008, Last updated: 19/03/2008, Compliance check: V, 06/02/2009Losartan potassium Cardiovascular diseases … Key facts Losartan potassium Cardiovascular diseasesP/9/2008Losartan … diseasesP/9/2008Losartan potassium Film-coated tablet Age-appropriate … -
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Orphan designation: Octreotide chloride for: Treatment of acromegaly
Date of first decision: 12/06/2009, Positive, Last updated: 30/05/2018AB, Sweden, for octreotide chloride (lipid depot solution) for … information to show that octreotide chloride (lipid depot solution) might … into a muscle. In octreotide chloride (lipid depot solution), octreotide … -
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Orphan designation: tegafur, gimeracil, oteracil potassium for: Treatment of gastric cancer
Date of first decision: 20/12/2007, Withdrawn, Last updated: 28/03/2011tegafur, gimeracil, oteracil potassium for the treatment of gastric … tegafur, gimeracil, oteracil potassium might be of potential significant … Tegafur, gimeracil, oteracil potassium is a product that combines … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tolonium chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002170-PIP01-17, Route(s) of administration: Dental use, Oromucosal use, Pharmaceutical form(s): Oromucosal gel
Decision date: 01/12/2017, Last updated: 05/03/2018, Compliance check: XKey facts Tolonium chloride OtherP/0370/2017EMEA-002170-PIP01-17 … specific waiver for tolonium chloride (EMEA-002170-PIP01-17) PDF … specific waiver for tolonium chloride (EMEA-002170-PIP01-17) 30 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Methacholine chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic
PIP number: EMEA-002120-PIP01-17, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Powder for nebuliser solution
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: XProvocholine Methacholine chloride DiagnosticP/0202/2017EMEA-002120-PIP01-17 … of waiver for methacholine chloride (EMEA-002120-PIP01-17) PDF … of waiver for methacholine chloride (EMEA-002120-PIP01-17 …