2582 results
Keyword calcium carbonate Remove keyword
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Referral: Calcium Sandoz
Calcium lactate gluconate, Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Calcium Sandoz … Commission final decision Overview Calcium is an essential mineral … Medicinal products containing calcium lactate gluconate and calcium carbonate have been nationally authorised … -
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Referral: Calcitugg
Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/06/2003, EC decision date: 01/12/2003, Last updated: 21/01/2004Commission final decision Overview Calcium is essential for a number … containing cholecalciferol and/or calcium carbonate have been nationally authorised … the benefit/risk ratio of calcium … -
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Opinion/decision on a Paediatric investigation plan (PIP): cholecalciferol, calcium carbonate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: P/0341/2014, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 22/12/2014, Last updated: 23/02/2015, Compliance check: XKey facts cholecalciferol calcium carbonate OtherP/0341/2014P/0341/2014 … product specific waiver for calcium carbonate) / cholecalciferol (in combination … proposed product-specific waiver Calcium carbonate) / cholecalciferol (in combination … -
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Opinion/decision on a Paediatric investigation plan (PIP): calcium carbonate, cholecalciferol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0325/2014, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2014, Last updated: 23/02/2015, Compliance check: XKey facts calcium carbonate cholecalciferol OncologyP/0325/2014P/0325/2014 … product specific waiver for calcium carbonate) / cholecalciferol (in combination … product- specific waiver Calcium carbonate) / cholecalciferol (in combination … -
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Referral: Norsed Combi D
risedronate sodium, Calcium carbonate, colecalciferol, associated names: Actonel Combi D, Optinate Plus Ca&D, Opticalcio D3, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 24/06/2010, EC decision date: 05/10/2010, Last updated: 13/09/2011substances, risedronate sodium, calcium carbonate and colecalciferol. It consists … granules containing 1000 mg calcium as calcium … risedronate sodium 35 mg tablets / calcium plus colecalciferol 1000 … -
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Referral: Fortipan Combi D
risedronate sodium, Calcium carbonate, colecalciferol, associated names: Actocalcio D3, Acrelcombi, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 24/06/2010, EC decision date: 05/10/2010, Last updated: 13/09/2011substances, risedronate sodium, calcium carbonate and colecalciferol (vitamin … granules containing 1000 mg calcium as calcium … risedronate sodium 35 mg tablets / calcium plus colecalciferol 1000 … -
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Opinion/decision on a Paediatric investigation plan (PIP): 224 Radium adsorbed in calcium carbonate microparticles
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-003199-PIP01-22, Route(s) of administration: Intraperitoneal use, Pharmaceutical form(s): Suspension for injection
Decision date: 08/07/2022, Last updated: 19/06/2023, Compliance check: Xfacts 224 Radium adsorbed in calcium carbonate microparticles OncologyP/0252/2022EMEA-003199-PIP01-22 … for 224Radium adsorbed in calcium carbonate microparticles (EMEA-003199-PIP01-22 … for 224Radium adsorbed in calcium carbonate microparticles (EMEA-003199-PIP01-22 … -
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Human medicine European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 15/01/2015, Revision: 21, Authorised, Last updated: 24/05/2023Sevelamer carbonate Winthrop (previously Sevelamer … Winthrop (previously Sevelamer carbonate Zentiva) Nutritional and … Sevelamer carbonate Winthrop is a medicine used … -
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Human medicine European public assessment report (EPAR): Renvela
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 09/06/2009, Revision: 26, Authorised, Last updated: 28/06/2023other treatments such as calcium supplements and vitamin D … active substance sevelamer carbonate. Expand section Collapse section … substance in Renvela, sevelamer carbonate, is a phosphate binder. When … -
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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: 30/06/2023citratepotassium hydrogen carbonate Overview Sibnayal is a medicine … citrate and potassium hydrogen carbonate. How is Sibnayal used? Sibnayal … citrate and potassium hydrogen carbonate. Because the combination is … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2-(3-(1-carboxy-5-[(6-[18F]fluoropyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002608-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 04/10/2019, Last updated: 25/03/2020, Compliance check: X -
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Referral: Calcichew D3 mite
calcium, colecalciferol, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/06/2003, EC decision date: 01/12/2003, Last updated: 21/01/2004intestinal absorption of calcium. Calcium is essential for a number … containing cholecalciferol and/or calcium carbonate have been nationally authorised … and associated names, INN-Calcium 500 mg / cholecalciferol … -
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Referral: Calcichew D3
colecalciferol, calcium, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/06/2003, EC decision date: 01/12/2003, Last updated: 21/01/2004intestinal absorption of calcium. Calcium is essential for a number … containing cholecalciferol and/or carbonate calcium have been nationally authorised … and associated names, INN-Calcium 500 mg / cholecalciferol … -
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Orphan designation: Immunoglobulin G1, anti-(human tumour-associated calcium signal transducer 2)(human-Mus musculus monoclonal hRS7 heavy chain), disulfide with human-Mus musculus monoclonal hRS7 κ-chain, dimer, hexakis(thioether) with (4S)-4-[[[[4-[[(2S)-2-(4-aminobutyl)-2-[[2-[2-[[26-[4-[[[[4-[(3-mercapto-2,5-dioxo-1-pyrrolidinyl)methyl]cyclohexyl]carbonyl]amino]methyl]-1H-1,2,3-triazol-1-yl]-3,6,9,12,15,18,21,24-octaoxahexacos-1-yl]amino]-2-oxoethoxy]acetyl]amino]-1-oxoethyl]amino]phenyl]methoxy]carbonyl]oxy]-4,11-diethyl-9-hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (sacituzumab govitecan) for: Treatment of pancreatic cancer
Date of designation: 15/10/2014, Positive, Last updated: 28/07/2021anti-(human tumour-associated calcium signal transducer 2)(human-Mus … 4S)-4-[[[[4-[[(2S)-2-(4-aminobutyl)-2-[[2-[2-[[26-[4-[[[[4-[(3-mercapto-2,5-dioxo-1-pyrrolidinyl)methyl]cyclohexyl]carbonyl]amino]methyl]-1H-1,2,3-triazol-1-yl]-3,6,9,12,15,18,21,24-octaoxahexacos-1-yl]amino]-2-oxoethoxy]acetyl]amino]-1-oxoethyl]amino]phenyl]methoxy]carbonyl]oxy]-4,11-diethyl-9-hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione … -
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Orphan designation: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid for: Treatment of acute myeloid leukaemia
Date of designation: 22/08/2014, Positive, Last updated: 23/05/2018methyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid … methyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid … -
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Orphan designation: 5-(2,6-Difluoro-phenoxy)-3(R,S)-{2(S)-[2(S)-(3-methoxycarbonyl-2(S)-{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3-methyl-butyrylamino]-propionylamino}-4-oxo-pentanoic acid methyl ester for: Treatment of neonatal brain injury
Date of designation: 23/10/2006, Withdrawn, Last updated: 08/05/2015{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3-methyl-butyrylamino]-propionylamino}-4-oxo-pentanoic … 5-(2,6-Difluoro-phenoxy)-3(R,S)-{2(S)-[2(S)-(3-methoxycarbonyl-2(S)-{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3-methyl-butyrylamino]-propionylamino}-4-oxo-pentanoic … -
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Orphan designation: Lithium carbonate for: treatment of TBR1-related disorder
Date of designation: 21/06/2022, Positive, Last updated: 22/09/2022Lithium carbonate … Lithium carbonate … -
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Orphan designation: Lithium carbonate for: Treatment of familial adenomatous polyposis (FAP)
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022Lithium carbonate … Lithium carbonate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Veltassa, Patiromer calcium
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001720-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: XActive substance Patiromer calcium Therapeutic area Other Decision … investigation plan for patiromer calcium (Veltassa), (EMEA-001720-PIP01-14-M02 … investigation plan for patiromer calcium (Veltassa), (EMEA-001720-PIP01-14-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lanthanum carbonate hydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000637-PIP02-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Chewable tablet, Oral powder
Decision date: 12/09/2018, Last updated: 05/02/2019, Compliance check: Xassociated names Lanthanum carbonate hydrate Uro-nephrologyP/0303/2018EMEA-000637-PIP02-10-M06 … investigation plan for lanthanum carbonate hydrate (Fosrenol and associated … Lanthanum carbonate hydrate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lanthanum carbonate hydrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-000637-PIP01-09-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Chewable tablet, Granules
Decision date: 28/11/2011, Last updated: 28/11/2011, Compliance check: Xassociated name Foznol Lanthanum carbonate hydrate Uro-nephrologyP/22/2010EMEA-000637-PIP01-09-M01 … Lanthanum carbonate hydrate … -
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Human medicine European public assessment report (EPAR): Telzir
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 48, Authorised, Last updated: 23/08/2022Active substance fosamprenavir calcium International non-proprietary … fosamprenavir fosamprenavir calcium … -
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Human medicine European public assessment report (EPAR): Veltassa
patiromer sorbitex calcium, Hyperkalemia
Date of authorisation: 19/07/2017, Revision: 7, Authorised, Last updated: 03/04/2023gt;VeltassaEMEA/H/C/004180patiromer sorbitex calciumpatiromerHyperkalemiaV03AE09 Publication details >Vifor … atiromer patiromer sorbitex calcium … -
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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: 13/04/2023monohydrate / Potassium hydrogen carbonate … monohydrate Potassium hydrogen carbonate … -
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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 …