779 results
Keyword Metformin Remove keyword
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Human medicine European public assessment report (EPAR): Qtrilmet
metformin hydrochloride, Saxagliptin, dapagliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2019, Revision: 2, Withdrawn, Last updated: 09/10/2020metformin hydrochloride / saxagliptin … Qtrilmet metformin hydrochloride saxagliptin d … hydrochloride saxagliptin dapagliflozin metformin hydrochloride Saxagliptin d … -
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Opinion/decision on a Paediatric investigation plan (PIP): Eucreas, vildagliptin, metformin hydrochloride
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-000703-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 03/09/2010, Last updated: 29/10/2010, Compliance check: XActive substance vildagliptin metformin hydrochloride Therapeutic … waiver for vildagliptin / metformin hydrochloride (Eucreas … waiver for vildagliptin / metformin hydrochloride (Eucreas … -
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Opinion/decision on a Paediatric investigation plan (PIP): Janumet, sitagliptin phosphate monohydrate, metformin hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Sitagliptin phosphate monohydrate, metformin hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: Xiptin phosphate monohydrate, metformin hydrochloride Endocrinology … iptin phosphate monohydrate, metformin hydrochloride … sitagliptin phosphate monohydrate, metformin hydrochloride (Janumet … -
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Opinion/decision on a Paediatric investigation plan (PIP): Efficib, sitagliptin phosphate monohydrate, metformin hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Sitagliptin phosphate monohydrate, metformin hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: Xiptin phosphate monohydrate, metformin hydrochloride Endocrinology … iptin phosphate monohydrate, metformin hydrochloride … sitagliptin phosphate monohydrate, metformin hydrochloride (Efficib) EMEA-000213-PIP01-07 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Velmetia, sitagliptin phosphate monohydrate, metformin hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Sitagliptin phosphate monohydrate, metformin hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: Xiptin phosphate monohydrate, metformin hydrochloride Endocrinology … iptin phosphate monohydrate, metformin hydrochloride … sitagliptin phosphate monohydrate, metformin hydrochloride (Velmetia … -
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Referral: Glucophage/Glucophage Forte/Risidon/Dianben
metformin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/10/2000, EC decision date: 06/02/2001, Last updated: 07/02/2001Glucophage/Glucophage Forte/Risidon/Dianben (metformin) contains the active substance … contains the active substance metformin which is an oral antihyperglycaemic … the benefit/risk ratio of metformin is considered to be favourable … -
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Orphan designation: Metformin for: Treatment of progressive myoclonic epilepsy type 2 (Lafora disease)
Date of designation: 12/12/2016, Positive, Last updated: 11/11/2022Metformin Overview On 12 December 2016 … en Red (CIBER), Spain, for metformin for the treatment of progressive … medicine expected to work? Metformin blocks production of glucose … -
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Opinion/decision on a Paediatric investigation plan (PIP): Saxagliptin, Metformin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Saxagliptin / metformin, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/12/2009, Last updated: 25/01/2010, Compliance check: XSaxagliptin / metformin Endocrinology, -gynacology-f … Key facts Saxagliptin Metformin Endocrinology, -gynacology-fertility-metabolismP/240/2009Saxagliptin … gynacology-fertility-metabolismP/240/2009Saxagliptin / metformin Film-coated tablet Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): metformin hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001352-PIP01-12-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Effervescent tablet
Decision date: 29/09/2014, Last updated: 05/11/2014, Compliance check: XKey facts metformin hydrochloride Endocrinology … paediatric investigation plan for metformin (hydrochloride) (EMEA-001352-PIP01-12-M01 … paediatric investigation plan for metformin (hydrochloride) (EMEA-001352-PIP01-12-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ertugliflozin, Metformin
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-001532-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 07/03/2014, Last updated: 16/04/2014, Compliance check: Xtive substance Ertugliflozin Metformin Therapeutic area Endocrinology … waiver for ertugliflozin / metformin (EMEA-001532-PIP01-13 … waiver for ertugliflozin / metformin (EMEA-001532-PIP01-13) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Metformin, Rosuvastatin
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-001479-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 23/09/2013, Last updated: 15/11/2013, Compliance check: XKey facts Metformin Rosuvastatin Endocrinology … product specific waiver for metformin / rosuvastatin, (EMEA-001479-PIP01-13 … product specific waiver for metformin / rosuvastatin, (EMEA-001479-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): canagliflozin, Metformin
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-001111-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 10/06/2011, Last updated: 14/07/2011, Compliance check: Xtive substance canagliflozin Metformin Therapeutic area Endocrinology … waiver for canagliflozin / metformin (EMEA-001111-PIP01-10) in … waiver for canagliflozin / metformin (EMEA-001111-PIP01-10) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): linagliptin, metformin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: P/3/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/01/2010, Last updated: 25/02/2010, Compliance check: XKey facts linagliptin metformin Endocrinology, -gynacology-fertility-metabolismP/3/2010P/3/2010 … specific waiver for linagliptin, metformin (EMA-000699-PIP01-09) in … specific waiver for linagliptin, metformin (EMA-000699-PIP01-09) in … -
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Orphan designation: metformin, l-citrulline for: Treatment of Duchenne muscular dystrophy
Date of designation: 17/01/2018, Positive, Last updated: 30/07/2019metforminl-citrulline Overview On 17 January 2018 … Duchenne UK, United Kingdom, for metformin and L-citrulline for the … work? This medicine contains metformin and L-citrulline. In DMD … -
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Opinion/decision on a Paediatric investigation plan (PIP): dapagliflozin, metformin hydrochloride
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-001151-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XKey facts dapagliflozin metformin hydrochloride Endocrinology … waiver for dapagliflozin / metformin (hydrochloride) (EMEA-001151-PIP02-17 … waiver for dapagliflozin / metformin (hydrochloride) 30 … -
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Opinion/decision on a Paediatric investigation plan (PIP): dapagliflozin, Saxagliptin, metformin hydrochloride
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-002249-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: Xdapagliflozin Saxagliptin metformin hydrochloride Endocrinology … dapagliflozin / saxagliptin / metformin (hydrochloride) (EMEA-002249-PIP01-17 … dapagliflozin / saxagliptin / metformin (hydrochloride) (EMEA-002249-PIP01-17 … -
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Opinion/decision on a Paediatric investigation plan (PIP): metformin hydrochloride, rosuvastatin calcium
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-001508-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 29/11/2013, Last updated: 06/01/2014, Compliance check: XActive substance metformin hydrochloride rosuvastatin … product specific waiver for metformin hydrochloride / rosuvastatin … product specific waiver for metformin hydrochloride / rosuvastatin … -
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Opinion/decision on a Paediatric investigation plan (PIP): dapagliflozin, metformin hydrochloride
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-001151-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 26/09/2011, Last updated: 18/10/2011, Compliance check: XKey facts dapagliflozin metformin hydrochloride Endocrinology … waiver for dapagliflozin / metformin hydrochloride (EMEA-001151 … waiver for dapagliflozin / metformin hydrochloride (EMEA-001151- PIP01-11 … -
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Opinion/decision on a Paediatric investigation plan (PIP): alogliptin benzoate, metformin hydrochloride
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-001128-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/07/2011, Last updated: 09/08/2011, Compliance check: XKey facts alogliptin benzoate metformin hydrochloride Endocrinology … for alogliptin (benzoate) / metformin (hydrochloride) (EMEA-001128-PIP01-10 … for alogliptin (benzoate) / metformin (hydrochloride) (EMEA-001128-PIP01-10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): sitagliptin phosphate monohydrate, metformin hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: P/93/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Modified-release tablet
Decision date: 02/06/2010, Last updated: 26/07/2010, Compliance check: Xsitagliptin phosphate monohydrate metformin hydrochloride Endocrinology … sitagliptin phosphate monohydrate / metformin hydrochloride (Janumet and … sitagliptin phosphate monohydrate / metformin hydrochloride (Janumet … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sitagliptin (hydrochloride monohydrate), metformin hydrochloride
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-002732-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 15/07/2020, Last updated: 16/06/2021, Compliance check: Xhydrochloride monohydrate) metformin hydrochloride Endocrinology … hydrochloride monohydrate) / metformin (hydrochloride) (EMEA-002732-PIP02-20 … hydrochloride monohydrate) / metformin (hydrochloride) (EMEA-002732-PIP02-20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): pioglitazone hydrochloride, spironolactone metformin hydrochloride
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: EMEA-002187-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/04/2021, Last updated: 12/01/2022, Compliance check: Xhydrochloride spironolactone metformin hydrochloride Endocrinology … granting of a waiver for metformin (hydrochloride) / pioglitazone … granting of a waiver for metformin (hydrochloride) / pioglitazone … -
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Opinion/decision on a Paediatric investigation plan (PIP): (2S,3R,4R,5S,6R)-2-(4-Chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol, Metformin
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-001182-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/10/2011, Last updated: 29/11/2011, Compliance check: X2S,3R,4R,5S,6R)-2-(4-Chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol Metformin Endocrinology, -gynacology-fertility-metabolismP/271/2011EMEA-001182-PIP01-11 … 2S,3R,4R,5S,6R)-2-(4-Chloro-3-{3-[(S)- (tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol / metformin (EMEA-001182-PIP01-11 … -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015hydrochloride escitalopram oxalate metformin hydrochloride trimetazidine … dihydrochloride rizatriptan benzoate metformin fluconazole eletriptan rizatriptan ebastine ibuprofen desmopressin aciclovir levetiracetam irbesartan venlafaxine ciprofloxacin cefpodoxime … -
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Press release: EMA update on metformin diabetes medicines
Last updated: 06/12/2019EMA update on metformin diabetes medicines … found in a small number of metformin diabetes medicines outside … NDMA in the affected non-EU metformin medicines are very low and …