1578 results
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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): 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Date of authorisation: 26/03/2015, Withdrawn, Last updated: 27/04/2017lamivudine / raltegravir potassium … bis lamivudine raltegravir potassium lamivudine raltegravir potassium … -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Withdrawn application: Raltegravir Viatris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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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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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): Tookad
padeliporfin di-potassium, Prostatic Neoplasms
Date of authorisation: 10/11/2017,
, Revision: 6, Authorised, Last updated: 07/12/2022
substance padeliporfin di-potassium International non-proprietary … adeliporfin padeliporfin di-potassium … -
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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: EMEA-000008-PIP01-07, Route(s) of administration: Oral use, 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, 06/02/2009Key facts Losartan potassium Cardiovascular diseasesP/9/2008EMEA-000008-PIP01-07 … associated names, losartan potassium EMEA-000008-PIP01-07 in accordance … associated names, losartan potassium EMEA-000008-PIP01-07 in accordance … -
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Orphan designation: tegafur, gimeracil, oteracil potassium for: Treatment of gastric cancer
Date of designation: 20/12/2007, Withdrawn, Last updated: 28/03/2011gafur / gimeracil / oteracil potassium … Tegafur, gimeracil, oteracil potassium for the treatment of gastric … Tegafur, gimeracil, oteracil potassium for the treatment of gastric … -
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Withdrawn application: Tookad
padeliporfin, date of withdrawal: 14/12/2021, Post-authorisation, Last updated: 28/01/2022adeliporfin padeliporfin di-potassium … -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001390-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/04/2013, Last updated: 31/05/2013, Compliance check: XKey facts Losartan potassium Amlodipine besilate Cardiovascular … amlodipine (besilate) / losartan (potassium) (EMEA-001390-PIP01-12) PDF … amlodipine (besilate) / losartan (potassium) (EMEA- 001390-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine camsylate, Losartan potassium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000886-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/09/2010, Last updated: 29/10/2010, Compliance check: XAmlodipine camsylate Losartan potassium Cardiovascular diseasesP/188/2010EMEA-000886-PIP01-10 … amlodipine camsylate / losartan potassium (EMEA-000886-PIP01-10) PDF … 6-PIP01-10 Decision Losartan potassium, Amlodipine camsylate 7 … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of cystinuria
Date of designation: 09/01/2020, Positive, Last updated: 13/04/2023assium citrate monohydrate / Potassium hydrogen carbonate … tassium citrate monohydrate Potassium hydrogen carbonate … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021assium citrate monohydrate / Potassium hydrogen carbonate … Tripotassium citrate monohydrate and potassium hydrogen carbonate for the … tripotassium citrate monohydrate and potassium hydrogen carbonate (also … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: Bismuth subcitrate potassium / Metronidazole / Tetracycline hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule
Decision date: 20/04/2009, Last updated: 10/06/2009, Compliance check: XBismuth subcitrate potassium / Metronidazole / Tetracycline … Key facts Bismuth subcitrate potassium Metronidazole Tetracycline … Gastroentology-HepatologyP/74/2009Bismuth subcitrate potassium / Metronidazole / Tetracycline … -
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Opinion/decision on a Paediatric investigation plan (PIP): sodium sulfate, potassium sulfate, magnesium sulfate heptahydrate
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: P/116/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 07/07/2010, Last updated: 29/07/2010, Compliance check: XKey facts sodium sulfate potassium sulfate magnesium sulfate … waiver for sodium sulfate/potassium sulfate/magnesium sulfate … waiver for sodium sulfate/potassium sulfate/magnesium sulfate … -
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Opinion/decision on a Paediatric investigation plan (PIP): L-Lactic acid, citric acid, potassium bitartrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002917-PIP01-20, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 08/09/2021, Last updated: 11/01/2023, Compliance check: XL-Lactic acid citric acid potassium bitartrate Infectious diseasesP/0378/2021EMEA-002917-PIP01-20 … L-lactic acid / citric acid / potassium bitartrate, (EMEA-002917-PIP01-20 … L-lactic acid / citric acid / potassium bitartrate, (EMEA-002917-PIP01-20 … -
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Orphan designation: sodium oxybate, calcium oxybate, magnesium oxybate, potassium oxybate for: Treatment of idiopathic hypersomnia
Date of designation: 06/01/2021, Positive, Last updated: 18/05/2021oxybate / magnesium oxybate / potassium oxybate … oxybate, magnesium oxybate, potassium oxybate, sodium oxybate for … oxybate, magnesium oxybate, potassium oxybate, sodium oxybate … -
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Opinion/decision on a Paediatric investigation plan (PIP): magnesium sulfate heptahydrate (BLI800), Sodium sulphate anhydrou, potassium sulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000816-PIP02-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Concentrate for oral solution
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: XSodium sulphate anhydrou potassium sulfate Therapeutic area … sulphate heptahydrate / potassium sulphate / sodium sulphate … sulphate heptahydrate / potassium sulphate / sodium sulphate … -
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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 … paediatric investigation plan for potassium (chloride) / magnesium (sulphate … paediatric investigation plan for potassium (chloride) / magnesium (sulphate … -
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Referral: Synulox Lactating Cow
Amoxicillin trihydrate, potassium clavulanate, Prednisolone, associated names: Avuloxil, Synulox LC, Synulox comp. vet, Synulox Endomammario, Article 34
Status: European Commission final decision, opinion/position date: 07/06/2011, EC decision date: 20/10/2011, Last updated: 17/11/201150 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone … inn): amoxicillin trihydrate, potassium clavulanate, prednisolone … 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone … -
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Orphan designation: Potassium 2-chloro-3-(1-hydroxy-5,6,7,8-tetrahydronaphthalen-2-yl)-6-oxo-5-phenyl-6,7-dihydrothieno[2,3-b]pyridin-4-olate monohydrate for: Treatment of adrenoleukodystrophy
Date of designation: 09/12/2022, Positive, Last updated: 13/03/2023Potassium 2-chloro-3-(1-hydroxy-5,6,7,8-tetrahydronaphthalen-2-yl)-6-oxo-5-phenyl-6,7-dihydrothieno[2,3-b]pyridin-4-olate … Potassium 2-chloro-3-(1-hydroxy-5,6,7,8-tetrahydronaphthalen-2-yl)-6-oxo-5-phenyl-6,7-dihydrothieno[2,3-b]pyridin-4-olate … -
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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 … citrate /sodium sulfate / potassium chloride (Clensia) PDF icon … sodium sulfate anhydrous) / potassium chloride (Clensia), (EMEA-001356-PIP02-12-M04 … -
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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 … alfa- ketoglutaric acid / arginine / potassium chloride / magnesium chloride … alfa- ketoglutaric acid / arginine / potassium chloride / magnesium chloride … -
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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, 16/10/2009tyrosine valine sodium chloride potassium acetate magnesium acetate … valine, sodium chloride, potassium acetate, magnesium acetate … valine, sodium chloride, potassium acetate, magnesium acetate …