274 results
Keyword Sitagliptin Remove keyword
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Human medicine European public assessment report (EPAR): Sitagliptin Accord
sitagliptin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 25/04/2022,
, Authorised, Last updated: 21/07/2022
Sitagliptin Accord Diabetes Mellitus Glucose … Sitagliptin Accord … EMA/128895/2022 EMEA/H/C/005598 Sitagliptin Accord sitagliptin) An overview of Sitagliptin Accord and why it is authorised … -
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Human medicine European public assessment report (EPAR): Sitagliptin SUN
sitagliptin fumarate, Diabetes Mellitus, Type 2
Date of authorisation: 09/12/2021,, Revision: 1, Authorised, Last updated: 27/10/2022
Sitagliptin SUN Endocrine System Diseases Diabetes … Sitagliptin SUN … EMA/604084/2021 EMEA/H/C/005741 Sitagliptin SUN sitagliptin) An overview of Sitagliptin SUN and why it is authorised … -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023Sitagliptin / Metformin hydrochloride … Sitagliptin / Metformin hydrochloride Sun … initial authorisation) Sitagliptin/Metformin hydrochloride Sun sitagliptin / metformin hydrochloride … -
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Human medicine European public assessment report (EPAR): Tesavel
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 10/01/2008, Revision: 27, Authorised, Last updated: 02/02/2023sitagliptin … TESAVEL (clone Januvia), INN-sitagliptin 7 Westferry Circus … for the public Tesavel sitagliptin This is a summary of the … -
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Human medicine European public assessment report (EPAR): Xelevia
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 37, Authorised, Last updated: 31/01/2023sitagliptin … for the public Xelevia sitagliptin This is a summary of the … contains the active substance sitagliptin. It is available as tablets … -
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Human medicine European public assessment report (EPAR): Januvia
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 20/03/2007, Revision: 30, Authorised, Last updated: 30/06/2022sitagliptin … for the public Januvia sitagliptin This is a summary of the … contains the active substance sitagliptin. It is available as tablets … -
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Human medicine European public assessment report (EPAR): Ristaben
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2010, Revision: 24, Authorised, Last updated: 01/07/2022sitagliptin … istaben (clone Januvia), INN-sitagliptin EMA/790269/2014 EMEA/H/C/001234 … for the public Ristaben sitagliptin This is a summary of the … -
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Accord
metformin hydrochloride, sitagliptin hydrochloride monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 22/07/2022,, Revision: 1, Authorised, Last updated: 01/09/2022
Sitagliptin / Metformin hydrochloride … Sitagliptin / Metformin hydrochloride … EMA/382461/2022 EMEA/H/C/005850 Sitagliptin/Metformin hydrochloride Accord sitagliptin/metformin hydrochloride) An overview … -
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan
sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 21/06/2022
Sitagliptin / Metformin hydrochloride … Sitagliptin / Metformin hydrochloride … EMA/2302/2022 EMEA/H/C/005678 Sitagliptin/Metformin hydrochloride Mylan sitagliptin/ metformin hydrochloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): Januvia, sitagliptin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000470-PIP01-08-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/10/2019, Last updated: 21/09/2021, Compliance check: V, 28/02/2020Januvia Active substance sitagliptin Therapeutic area Endocrinology … Januvia Januvia sitagliptin sitagliptin sitagliptin … -
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Human medicine European public assessment report (EPAR): Velmetia
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/07/2008, Revision: 35, Authorised, Last updated: 20/02/2023sitagliptin / metformin … for the public Velmetia sitagliptin / metformin hydrochloride … contains two active substances, sitagliptin and metformin hydrochloride … -
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Human medicine European public assessment report (EPAR): Efficib
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/07/2008, Revision: 32, Authorised, Last updated: 31/01/2023sitagliptin / metformin … for the public Efficib sitagliptin / metformin hydrochloride … contains two active substances, sitagliptin and metformin hydrochloride … -
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Human medicine European public assessment report (EPAR): Janumet
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/07/2008,
Date of refusal: 18/02/2009, Revision: 29, Authorised, Last updated: 18/11/2022sitagliptin / metformin … for the public Janumet sitagliptin / metformin hydrochloride … contains two active substances, sitagliptin and metformin hydrochloride … -
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Human medicine European public assessment report (EPAR): Ristfor
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2010, Revision: 25, Authorised, Last updated: 01/07/2022sitagliptin / metformin hydrochloride … for the public Ristfor sitagliptin / metformin hydrochloride … contains two active substances, sitagliptin and metformin hydrochloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tesavel, sitagliptin phosphate monohydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Sitagliptin (phosphate monohydrate), Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 21/05/2016, Last updated: 28/02/2017, Compliance check: XSitagliptin (phosphate monohydrate) Endocrinology … Sitagliptin (phosphate monohydrate … paediatric investigation plan for sitagliptin (phosphate monohydrate) (TESAVEL … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xelevia, sitagliptin phosphate monohydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000471-PIP01-08-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 21/05/2016, Last updated: 22/07/2016, Compliance check: XXelevia Active substance sitagliptin phosphate monohydrate Therapeutic … paediatric investigation plan for sitagliptin (phosphate monohydrate … paediatric investigation plan for sitagliptin (phosphate monohydrate … -
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Human medicine European public assessment report (EPAR): Steglujan
ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 23/03/2018, Revision: 9, Authorised, Last updated: 15/12/2022ertugliflozin / sitagliptin … Steglujan (ertugliflozin / sitagliptin) An overview of Steglujan … with either ertugliflozin or sitagliptin; patients who are already … -
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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: XSitagliptin phosphate monohydrate, metformin … Sitagliptin phosphate monohydrate, metformin … Investigation Plan for sitagliptin phosphate monohydrate, metformin … -
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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: XSitagliptin phosphate monohydrate, metformin … Sitagliptin phosphate monohydrate, metformin … Investigation Plan for sitagliptin phosphate monohydrate, metformin … -
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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: XSitagliptin phosphate monohydrate, metformin … Sitagliptin phosphate monohydrate, metformin … Investigation Plan for sitagliptin phosphate monohydrate, metformin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ertugliflozin, sitagliptin
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-001534-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/03/2014, Last updated: 20/03/2014, Compliance check: Xtive substance Ertugliflozin sitagliptin Therapeutic area Endocrinology … waiver for ertugliflozin / sitagliptin (EMEA-001534-PIP01-13) in … waiver for ertugliflozin / sitagliptin (EMEA-001534-PIP01-13) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): sitagliptin, atorvastatin
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-001275-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 21/08/2012, Last updated: 18/09/2012, Compliance check: XActive substance sitagliptin atorvastatin Therapeutic … product specific waiver for sitagliptin / atorvastatin (EMEA-001275-PIP01-12) 7 … product specific waiver for sitagliptin / atorvastatin (EMEA-001275-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): sitagliptin phosphate monohydrate, simvastatin
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 / simvastatin, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/08/2009, Last updated: 22/10/2009, Compliance check: XSitagliptin phosphate monohydrate / simvastatin Endocrinology … Key facts sitagliptin phosphate monohydrate simvastatin … product specific waiver for sitagliptin phosphate monohydrate / simvastatin … -
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Opinion/decision on a Paediatric investigation plan (PIP): simvastatin, sitagliptin phosphate monohydrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Simvastatin / sitagliptin phosphate monohydrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/08/2009, Last updated: 22/10/2009, Compliance check: XSimvastatin / sitagliptin phosphate monohydrate Endocrinology … Key facts simvastatin sitagliptin phosphate monohydrate Endocrinology … gynacology-fertility-metabolismP/170/2009Simvastatin / sitagliptin phosphate monohydrate Film-coated … -
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Opinion/decision on a Paediatric investigation plan (PIP): sitagliptin phosphate monohydrate, simvastatin
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 / simvastatin, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/08/2009, Last updated: 22/10/2009, Compliance check: XSitagliptin phosphate monohydrate / simvastatin Endocrinology … Key facts sitagliptin phosphate monohydrate simvastatin … product specific waiver for sitagliptin phosphate monohydrate / simvastatin …