2260 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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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: 17, Authorised, Last updated: 27/11/2020Sevelamer carbonate Winthrop (previously Sevelamer … Winthrop (previously Sevelamer carbonate Zentiva) Hyperphosphatemia Renal … Authorised sevelamer carbonate Overview 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: 22, Authorised, Last updated: 02/12/2020Authorised sevelamer carbonate Overview Renvela is a medicine … other treatments such as calcium supplements and vitamin D … active substance sevelamer carbonate. How is Renvela used? Renvela … -
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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, Authorised, Last updated: 03/05/2021citratepotassium 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
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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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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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 … 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 … 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 ... PDF … -
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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: 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: The 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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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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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021monohydratePotassium hydrogen carbonate Overview On 20 June 2017 … monohydrate and potassium hydrogen carbonate (also known as ADV7103) for … citrate) and potassium hydrogen carbonate (also known as potassium … -
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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: 06/04/2021monohydratePotassium hydrogen carbonate Overview On 9 January 2020 … monohydrate and potassium hydrogen carbonate (also known as ADV7103) for … monohydrate Potassium hydrogen carbonate … -
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Human medicine European public assessment report (EPAR): Telzir
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 46, Authorised, Last updated: 21/04/2021fosamprenavir fosamprenavir calcium … -
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Orphan designation: Doxorubicin carbon, iron magnetically targeted microparticles for: Treatment of hepatocellular carcinoma
Date of designation: 11/09/2002, Withdrawn, Last updated: 15/10/2009Doxorubicin carbon / iron magnetically targeted … doxorubicin carbon/iron magnetically targeted microparticles … designation of doxorubicin carbon/iron magnetically targeted microparticles … -
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Human medicine European public assessment report (EPAR): Veltassa
patiromer sorbitex calcium, Hyperkalemia
Date of authorisation: 19/07/2017,
, Revision: 2, Authorised, Last updated: 12/11/2020
gt;VeltassaEMEA/H/C/004180patiromer sorbitex calciumpatiromerHyperkalemiaV03AE09 This medicine is under additional … atiromer patiromer sorbitex calcium … -
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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, 15/11/2019monohydrated Potassium hydrogen carbonate Uro-nephrologyP/0355/2018EMEA-001357-PIP01-12-M02 … monohydrated / potassium hydrogen carbonate (EMEA-001357-PIP01-12-M02 … monohydrated / potassium hydrogen carbonate for treatment of renal tubular … -
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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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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 …