2527 results
Keyword calcium carbonate Remove keyword
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Human medicine European public assessment report (EPAR): Veltassa
patiromer sorbitex calcium, Hyperkalemia
Date of authorisation: 19/07/2017,
, Revision: 6, Authorised, Last updated: 08/11/2022
gt;VeltassaEMEA/H/C/004180patiromer sorbitex calciumpatiromerHyperkalemiaV03AE09 This medicine is under additional … atiromer patiromer sorbitex calcium … -
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Orphan designation: 1,2-Bis(methylsulphonyl)-1-(2-chloroethyl)-2-[(methylamino)carbonyl]hydrazine for: Treatment of acute myeloid leukaemia
Date of designation: 14/12/2005, Positive, Last updated: 09/02/2006 -
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Opinion/decision on a Paediatric investigation plan (PIP): Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complexes
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002293-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: XKey facts Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine … product specific waiver for calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2 … product specific waiver for calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Modified human papillomavirus capsid protein conjugated to the near-infrared dye silicate(5-),bis[N-[3- [(hydroxy-.kappa.O)dimethylsilyl]propyl]-3-sulfo-N,N-bis(3-sulfopropyl)-1-propanaminiumato(4-)][6- [[[3-[(29H,31H-phthalocyanin-yl-.kappa.N29,.kappa.N30,.kappa.N31,.kappa.N32)oxy]propoxy] carbonyl]amino]hexanoato(3-)]-, sodium (1:5)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002658-PIP01-19, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 29/01/2020, Last updated: 10/06/2020, Compliance check: X3-[(29H,31H-phthalocyanin-yl-.kappa.N29,.kappa.N30,.kappa.N31,.kappa.N32)oxy]propoxy] carbonyl]amino]hexanoato(3-)]-, sodium (1:5) OncologyP/0041/2020EMEA-002658-PIP01-19 … 3-[(29H,31H-phthalocyanin-yl-.kappa.N29,.kappa.N30,.kappa.N31,.kappa.N32)oxy]propoxy] carbonyl]amino]hexanoato(3-)]-, sodium (1:5 … -
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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: Xmonohydrated potassium hydrogen carbonate (ADV7103) Uro-nephrologyP/0214/2018EMEA-001535-PIP01-13-M01 … monohydrated / potassium hydrogen carbonate (ADV7103) (EMEA-001535-PIP01-13-M01 … monohydrated / potassium hydrogen carbonate for treatment of cystinuria … -
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Opinion/decision on a Paediatric investigation plan (PIP): (3Z,5S)-5-(hydroxymethyl)-1-[(2'-methyl[1,1'-biphenyl]-4-yl)-carbonyl]-3-pyrrolidinone-O-methyloxime
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001854-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet
Decision date: 29/01/2016, Last updated: 29/03/2016, Compliance check: X3Z,5S)-5-(hydroxymethyl)-1-[(2'-methyl[1,1'- biphenyl]-4-yl)-carbonyl]-3-pyrrolidinone-O-methyloxime … 3Z,5S)-5-(hydroxymethyl)-1-[(2'-methyl[1,1'- biphenyl]-4-yl)-carbonyl]-3-pyrrolidinone-O-methyloxime … -
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Opinion/decision on a Paediatric investigation plan (PIP): Iron, aqua carbonate hydroxy oxo starch sucrose complex
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000100-PIP01-07-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 03/05/2010, Last updated: 28/07/2010, Compliance check: XKey facts Iron, aqua carbonate hydroxy oxo starch sucrose … investigation plan for iron, aqua carbonate hydroxy oxo starch sucrose … investigation plan for iron, aqua carbonate hydroxy oxo starch sucrose … -
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Referral: Crestor 5 mg
rosuvastatin calcium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Overview Crestor (rosuvastatin calcium) is a selective 3-hydroxy-3-methylglutaryl … Name (INN): Rosuvastatin calcium: Background information PDF … medicineCrestor 5 mgrosuvastatin calciumAbout this procedureCHMP/145829/05 … -
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Referral: Lederfoline
calcium folinate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 20/03/2003, EC decision date: 30/06/2003, Last updated: 14/08/2003Commission final decision Overview Calcium folinate is the calcium salt of 5-formyl tetrahydrofolic … Lederfoline and associated names, (calcium folinate, solution for injection … Lederfoline, INN-Calcium Folinate The European … -
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Orphan designation: Acamprosate calcium for: Treatment of fragile X syndrome
Date of designation: 15/10/2014, Positive, Last updated: 03/11/2022Acamprosate calcium Overview On 15 October 2014 … Ireland, for acamprosate calcium for the treatment of fragile … brain function. Acamprosate calcium acts by increasing the effects … -
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Opinion/decision on a Paediatric investigation plan (PIP): rosuvastatin calcium
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: Rosuvastatin (calcium), Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/11/2010, Last updated: 07/12/2009, Compliance check: V, 11/10/2013Rosuvastatin (calcium) Cardiovascular diseases … associated names rosuvastatin calcium Cardiovascular diseasesP/229/2010Rosuvastatin … diseasesP/229/2010Rosuvastatin (calcium) Film-coated tablet Homozygous … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Atorvastatin calcium, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: V, 13/11/2009Atorvastatin calcium Endocrinology, -gynacology-f … associated names Atorvastatin calcium Endocrinology, -gynacology-fertility-metabolismP/53/2008Atorvastatin … gynacology-fertility-metabolismP/53/2008Atorvastatin calcium Film-coated tablet Age-appropriate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pitavastatin (calcium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000300-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/04/2016, Last updated: 21/12/2016, Compliance check: V, 19/08/2016associated names Pitavastatin (calcium) Endocrinology, -gynacology-fertility-metabolismP/0096/2016EMEA-000300-PIP01-08-M04 … investigation plan for pitavastatin (calcium) (Alipza and associated names … investigation plan for pitavastatin (calcium) (Alipza and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pitavastatin (calcium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000054-PIP01-07-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/04/2016, Last updated: 21/12/2016, Compliance check: V, 19/08/2016associated names Pitavastatin (calcium) Endocrinology, -gynacology-fertility-metabolismP/0095/2016EMEA-000054-PIP01-07-M04 … investigation plan for pitavastatin (calcium) (Livazo and associated names … investigation plan for pitavastatin (calcium) (Livazo and associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pitavastatin (calcium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000302-PIP01-08-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 05/10/2012, Last updated: 26/11/2012, Compliance check: Xassociated names Pitavastatin (calcium) Endocrinology, -gynacology-fertility-metabolismP/0233/2012EMEA-000302-PIP01-08-M03 … investigation plan for pitavastatin (calcium) (Pitavastatin and associated … investigation plan for pitavastatin (calcium) (Pitavastatin and associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pitavastatin (calcium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000301-PIP01-08-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 05/10/2012, Last updated: 23/11/2012, Compliance check: Xassociated names Pitavastatin (calcium) Endocrinology, -gynacology-fertility-metabolismP/0232/2012EMEA-000301-PIP01-08-M03 … investigation plan for pitavastatin (calcium) (Vezepra and associated … investigation plan for pitavastatin (calcium) (Vezepra and associated … -
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Orphan designation: (S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile (olutasidenib) for: Treatment of acute myeloid leukaemia (updated)
Date of designation: 29/05/2019, Positive, Last updated: 23/01/20236-oxo-1,6-dihydropyridine-2-carbonitrile (olutasidenib) Overview On … S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile (also known as FT-2102) for … S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile (olutasidenib)Treatment of … -
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Orphan designation: 1-(3-{4-[3,4-difluoro-2-(trifluoromethyl)phenyl]piperidine-1-carbonyl}-1H,4H,5H,6H,7H-pyrazolo[3,4- c]pyridin-6-yl)ethan-1-one (Tinlarebant) for: Treatment of Stargardt's disease
Date of designation: 25/05/2018, Positive, Last updated: 01/12/20221-(3-{4-[3,4-difluoro-2-(trifluoromethyl)phenyl]piperidine-1-carbonyl}-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridin-6-yl)ethan-1-one … 1-(3-{4-[3,4-difluoro-2-(trifluoromethyl)phenyl]piperidine-1-carbonyl}-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridin-6-yl)ethan-1-one … 1-(3-{4-[3,4-difluoro-2-(trifluoromethyl)phenyl]piperidine-1- carbonyl}-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridin-6-yl)ethan-1-one (also known as LBS-008) for … -
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Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1) for: Treatment of hypoparathyroidism
Date of designation: 19/10/2020, Positive, Last updated: 18/02/2021helps to regulate levels of calcium and phosphate in the body … may result in too little calcium and too much phosphate in … the effects of low blood calcium. What is the estimated number … -
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Orphan designation: (S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl-3,4-dihydropyrrolo[2,1-f][1,2,4]triazine-5-carbonitrile (tanziertib) for: Treatment of pemphigus
Date of designation: 15/10/2014, Withdrawn, Last updated: 22/02/2018rolo[2,1-f][1,2,4]triazine-5-carbonitrile (tanziertib) Overview This … S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl-3,4-dihydropyrrolo[2,1-f][1,2,4]triazine-5-carbonitrile for the treatment of pemphigus … S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl-3,4-dihydropyrrolo[2,1-f][1,2,4]triazine-5-carbonitrile for the treatment of pemphigus … -
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Orphan designation: 6-Amino-5-chloro-N-((1R)-1-(5-(((5-chloro-4-(trifluoromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-4-pyrimidinecarboxamide for: Treatment of glioma
Date of designation: 20/05/2021, Positive, Last updated: 18/03/2022oromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-4-pyrimidinecarboxamide … 6-Amino-5-chloro-N-((1R)-1-(5-(((5-chloro-4-(trifluoromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-4-pyrimidinecarboxamideTreatment … oromethyl)-2-pyridinyl)amino)carbonyl)-2-thiazolyl)ethyl)-4-pyrimid … -
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Opinion/decision on a Paediatric investigation plan (PIP): rosuvastatin calcium, acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002239-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/02/2018, Last updated: 18/04/2018, Compliance check: XKey facts rosuvastatin calcium acetylsalicylic acid Cardiovascular … waiver for rosuvastatin (calcium) / acetylsalicylic acid (EMEA … waiver for rosuvastatin (calcium) / acetylsalicylic acid (EMEA- 002239-PIP01-17 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002135-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: Xsubstance Ezetimibe rosuvastatin calcium Therapeutic area Cardiovascular … waiver for rosuvastatin (calcium) / ezetimibe (EMEA-002135-PIP01-17 … waiver for rosuvastatin (calcium) / ezetimibe (EMEA-002135- PIP01-17 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002131-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: Xsubstance Ezetimibe rosuvastatin calcium Therapeutic area Cardiovascular … waiver for rosuvastatin (calcium) / ezetimibe (EMEA-002131-PIP01-17 … waiver for rosuvastatin (calcium) / ezetimibe (EMEA-002131- PIP01-17 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002118-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 07/06/2017, Last updated: 25/07/2017, Compliance check: Xsubstance Ezetimibe rosuvastatin calcium Therapeutic area Cardiovascular … waiver for rosuvastatin (calcium) / ezetimibe (EMEA-002118- PIP01-17 … waiver for rosuvastatin (calcium) / ezetimibe (EMEA-002118- PIP01-17 …