12376 results
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Herbal medicinal product: Melaleucae aetheroleum
Melaleuca alternifolia (Maiden and Betche) Cheel, Tea-tree oil, F: Assessment finalised, Last updated: 15/03/2022branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … Tea tree oil Melaleuca alternifolia (Maiden and Betch) Cheel … branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … -
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Human medicine European public assessment report (EPAR): Nustendi
Bempedoic acid, Ezetimibe, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 27/03/2020,
, Revision: 5, Authorised, Last updated: 21/04/2022
substances bempedoic acid and ezetimibe. Nustendi is used in combination … statin taken together with ezetimibe. Nustendi can also be used … are not lowered enough by ezetimibe. The medicine can be used … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000007-PIP04-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/07/2012, Last updated: 22/08/2012, Compliance check: Xassociated names Active substance Ezetimibe Therapeutic area Cardiovascular … product specific waiver for ezetimibe (Ezetrol and associated names … product specific waiver for ezetimibe (Ezetrol and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000007-PIP01-07-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 28/03/2012, Last updated: 20/04/2012, Compliance check: V, 17/01/2013associated names Active substance Ezetimibe Therapeutic area Cardiovascular … paediatric investigation plan for Ezetimibe (Ezetrol and associated names … paediatric investigation plan for Ezetimibe (Ezetrol and associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Ezetimibe and simvastatin (fixed combination), Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 14/09/2008, Last updated: 10/10/2008, Compliance check: XEzetimibe and simvastatin (fixed combin … Ezetimibe and simvastatin (fixed combin … Word - Decision and Opinion Ezetimibe and simvastatin 000006-PIP0… … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002257-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XKey facts Rosuvastatin Ezetimibe Cardiovascular diseasesP/0090/2018EMEA-002257-PIP01-17 … waiver for rosuvastatin / ezetimibe (EMEA-002257-PIP01-17) PDF … waiver for rosuvastatin / ezetimibe (EMEA-002257-PIP01-17) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002207-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: XActive substance atorvastatin Ezetimibe Therapeutic area Cardiovascular … waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17 … waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/04/2018, Last updated: 26/07/2018, Compliance check: XSuvezen Active substance Ezetimibe Rosuvastatin Therapeutic … Ezetimibe Rosuvastatin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002202-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: XActive substance Rosuvastatin Ezetimibe Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … waiver for rosuvastatin / ezetimibe (EMEA-002202-PIP01-17 … waiver for rosuvastatin / ezetimibe (EMEA-002202-PIP01-17) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, atorvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001477-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/10/2013, Last updated: 18/11/2013, Compliance check: XActive substance Ezetimibe atorvastatin Therapeutic … product specific waiver for ezetimibe / atorvastatin (EMEA-001477-PIP01-13 … product specific waiver for ezetimibe / atorvastatin (EMEA-001477-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001478-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/10/2013, Last updated: 18/11/2013, Compliance check: XActive substance Ezetimibe Rosuvastatin Therapeutic … product specific waiver for ezetimibe / rosuvastatin (EMEA-001478-PIP01-13 … product specific waiver for ezetimibe / rosuvastatin (EMEA-001478-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001447-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 28/05/2013, Last updated: 24/06/2013, Compliance check: XKey facts Rosuvastatin Ezetimibe Cardiovascular diseasesP/0131/2013EMEA-001447-PIP01-12 … waiver for rosuvastatin / ezetimibe (EMEA-001447-PIP01-12) PDF … waiver for rosuvastatin / ezetimibe (EMEA-001447-PIP01-12) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000006-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/04/2011, Last updated: 12/05/2011, Compliance check: Xassociated names Active substance Ezetimibe simvastatin Therapeutic area … product specific waiver for ezetimibe/simvastatin (Inegy and associated names … product specific waiver for ezetimibe/simvastatin (Inegy and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: XActive substance Ezetimibe Rosuvastatin Therapeutic … product specific waiver for ezetimibe / rosuvastatin (EMEA-001344-PIP01-12 … product specific waiver for ezetimibe / rosuvastatin (EMEA-001344-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001278-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet
Decision date: 20/08/2012, Last updated: 17/09/2012, Compliance check: XActive substance Rosuvastatin Ezetimibe Therapeutic area Cardiovascular … waiver for rosuvastatin + ezetimibe (EMEA-001278-PIP01-12 … waiver for rosuvastatin + ezetimibe (EMEA-001278-PIP01-12) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000006-PIP03-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 23/07/2012, Last updated: 22/08/2012, Compliance check: Xassociated names Active substance Ezetimibe simvastatin Therapeutic area … product specific waiver for ezetimibe / simvastatin (Inegy and … product specific waiver for ezetimibe / simvastatin (Inegy and … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001447-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XKey facts Ezetimibe Rosuvastatin Cardiovascular … waiver for rosuvastatin / ezetimibe (Rosuvastatin/ezetimibe EGIS … waiver for rosuvastatin / ezetimibe (Rosuvastatin/ezetimibe EGIS … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003039-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/11/2021, Last updated: 20/02/2023, Compliance check: XKey facts Ezetimibe Rosuvastatin Cardiovascular … waiver for rosuvastatin / ezetimibe (EMEA-003039-PIP01-21) PDF … waiver for rosuvastatin / ezetimibe, (EMEA-003039-PIP01-21) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002202-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2020, Last updated: 17/06/2021, Compliance check: XKey facts Rosuvastatin Ezetimibe Cardiovascular diseasesP/0251/2020EMEA-002202-PIP02-20 … waiver for rosuvastatin / ezetimibe (Coroswera) (EMEA-002202-PIP02-20 … waiver for rosuvastatin / ezetimibe (Coroswera), (EMEA-002202-PIP02-20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002257-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 18/03/2020, Last updated: 28/07/2020, Compliance check: XRosuvastatin and associated names Ezetimibe Elpen and associated names … Active substance Rosuvastatin Ezetimibe Therapeutic area Cardiovascular … Rosuvastatin Ezetimibe … -
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Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002852-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/12/2020, Last updated: 22/09/2021, Compliance check: XActive substance atorvastatin Ezetimibe Therapeutic area Cardiovascular … waiver for atorvastatin / ezetimibe (EMEA-002852-PIP01-20) in … waiver for atorvastatin / ezetimibe (EMEA-002852-PIP01-20) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003018-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/10/2021, Last updated: 20/02/2023, Compliance check: XActive substance Ezetimibe Rosuvastatin Therapeutic … waiver for rosuvastatin / ezetimibe (EMEA-003018-PIP01-21) in … waiver for rosuvastatin / ezetimibe (EMEA-003018-PIP01-21) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, atorvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002649-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/06/2020, Last updated: 08/03/2021, Compliance check: XActive substance Ezetimibe atorvastatin Therapeutic … product specific waiver for ezetimibe / atorvastatin (EMEA-002649-PIP02-20 … product specific waiver for ezetimibe / atorvastatin (EMEA-002649-PIP02-20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002410-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/12/2018, Last updated: 13/02/2019, Compliance check: XActive substance atorvastatin Ezetimibe Therapeutic area Cardiovascular … atorvastatin Ezetimibe … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, atorvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002649-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 06/12/2019, Last updated: 06/04/2020, Compliance check: XActive substance Ezetimibe atorvastatin Therapeutic … Ezetimibe atorvastatin …