316 results
Keyword Atorvastatin Remove keyword
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Referral: Lipitor
atorvastatin, associated names: Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator, Zarator, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/09/2010, EC decision date: 13/12/2010, Last updated: 10/04/2012under other trade names: Atorvastatin, Atorvastatina Nostrum Atorvastatina Parke-Davis Atorvastatina Pharmacia, Cardyl, Edovin … Lipitor and associated names (atorvastatin, 10, 20, 40 and 80 mg tablets … Lipitor and associated names (atorvastatin, 10, 20, 40 and 80 mg tablets … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Commission final decision Overview Atorvastatin calcium is a synthetic 3 … LDL. The calcium salt of atorvastatin is used in the treatment … film-coated tablets contain atorvastatin calcium as active substance … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Commission final decision Overview Atorvastatin calcium is a synthetic 3 … LDL. The calcium salt of atorvastatin is used in the treatment … film-coated tablets contain atorvastatin calcium as active substance … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Commission final decision Overview Atorvastatin calcium is a synthetic 3 … LDL. The calcium salt of atorvastatin is used in the treatment … film-coated tablets contain atorvastatin calcium as active substance … -
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Referral: Sortis
atorvastatin, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 24/03/2006, EC decision date: 22/05/2006, Last updated: 09/12/2006associated names contain atorvastatin, a HMG-CoA-reductase inhibitor … and national procedures. Atorvastatin is currently indicated as … nonpharmacological measures is inadequate. Atorvastatin is also indicated to reduce … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium
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: Atorvastatin calcium, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: V, 13/11/2009Atorvastatin calcium Endocrinology, -gyna … Sortis and associated names Atorvastatin calcium Endocrinology, -gynacology-fertility-metabolismP/53/2008Atorvastatin … Paediatric Investigation Plan for Atorvastatin calcium (Sortis and associated … -
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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: XKey facts Atorvastatin Ezetimibe Cardiovascular … product specific waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17 … product specific waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17 … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Atorvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002005-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2016, Last updated: 10/01/2017, Compliance check: XKey facts amlodipine Atorvastatin Cardiovascular diseasesP/0306/2016EMEA-002005-PIP01-16 … specific waiver for amlodipine / atorvastatin (EMEA-002005-PIP01-16) PDF … specific waiver for amlodipine / atorvastatin (EMEA-002005-PIP01-16) 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: XKey facts Ezetimibe Atorvastatin Cardiovascular diseasesP/0273/2013EMEA-001477-PIP01-13 … specific waiver for ezetimibe / atorvastatin (EMEA-001477-PIP01-13) PDF … specific waiver for ezetimibe / atorvastatin (EMEA-001477-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, 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-001510-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/10/2013, Last updated: 18/11/2013, Compliance check: XKey facts amlodipine Atorvastatin Endocrinology, -gynacology-fertility-metabolismP/0261/2013EMEA-001510-PIP01-13 … specific waiver for amlodipine / atorvastatin (EMEA-001510-PIP01-13) PDF … specific waiver for amlodipine / atorvastatin (EMEA-001510-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan, Atorvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001472-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 23/09/2013, Last updated: 15/11/2013, Compliance check: XKey facts valsartan Atorvastatin Cardiovascular diseasesP/0231/2013EMEA-001472-PIP01-13 … specific waiver for valsartan / atorvastatin (EMEA-001472-PIP01-13) PDF … specific waiver for valsartan / atorvastatin (EMEA-001472-PIP01-13 … -
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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: XKey facts sitagliptin Atorvastatin Endocrinology, -gynacology-fertility-metabolismP/0186/2012EMEA-001275-PIP01-12 … waiver for sitagliptin / atorvastatin (EMEA-001275-PIP01-12) PDF … waiver for sitagliptin / atorvastatin (EMEA-001275-PIP01-12) 7 … -
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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 area Cardiovascular … specific waiver for ezetimibe / atorvastatin (EMEA-002649-PIP02-20) in … specific waiver for ezetimibe / atorvastatin (EMEA-002649-PIP02-20) 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-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: XKey facts Atorvastatin Ezetimibe Cardiovascular … product specific waiver for atorvastatin / ezetimibe (EMEA-002410-PIP01-18 … 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: XKey facts Ezetimibe Atorvastatin Cardiovascular diseasesP/0429/2019EMEA-002649-PIP01-19 … specific waiver for ezetimibe / atorvastatin (EMEA-002649-PIP01-19) PDF … Ezetimibe Atorvastatin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Atorvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002047-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 17/03/2017, Last updated: 21/04/2017, Compliance check: XKey facts Ezetimibe Atorvastatin calcium Cardiovascular diseasesP/0081/2017EMEA-002047-PIP01-16 … product specific waiver for atorvastatin (calcium) / ezetimibe (EMEA-002047 … product specific waiver for atorvastatin (calcium) / ezetimibe (EMEA-002047- PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin, perindopril arginine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001876-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 15/04/2016, Last updated: 02/06/2016, Compliance check: XKey facts Atorvastatin perindopril arginine Cardiovascular … product specific waiver for Atorvastatin / Perindopril (arginine … product specific waiver for Atorvastatin / Perindopril (arginine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, atorvastatin (calcium trihydrate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001204-PIP02-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 10/04/2015, Last updated: 06/07/2015, Compliance check: XKey facts Ezetimibe atorvastatin (calcium trihydrate) Cardiovascular … product-specific waiver for ezetimibe / atorvastatin (calcium trihydrate) (Atozet … product-specific waiver: Ezetimibe / atorvastatin (calcium trihydrate) for … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin, Perindopril, acetylsalicylic acid
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-001547-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/07/2015, Last updated: 25/08/2015, Compliance check: XKey facts Atorvastatin Perindopril acetylsalicylic … product specific waiver for atorvastatin / perindopril / acetylsalicylic … product specific waiver for atorvastatin / perindopril / acetylsalicylic … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium, Amlodipine besilate
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-001364-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: XKey facts Atorvastatin calcium Amlodipine besilate … for amlodipine (besylate) / atorvastatin (calcium), (EMEA-001364-PIP01-12 … for amlodipine (besylate) / atorvastatin (calcium), (EMEA-001364-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001353-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 22/01/2013, Last updated: 03/04/2013, Compliance check: XKey facts Atorvastatin calcium Amlodipine besilate … for amlodipine (besylate) / atorvastatin (calcium), (EMEA-001353-PIP01-12 … for amlodipine (besylate) / atorvastatin (calcium), (EMEA- 001353-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): glimepiride, Atorvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001232-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/05/2012, Last updated: 25/06/2012, Compliance check: XKey facts glimepiride Atorvastatin calcium Cardiovascular diseasesP/0103/2012EMEA-001232-PIP01-11 … waiver for glimepiride / atorvastatin (calcium), (EMEA-001232-PIP01-11 … waiver for glimepiride / atorvastatin (calcium), (EMEA-001232-PIP01-11 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Atorvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001204-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/01/2012, Last updated: 24/02/2012, Compliance check: XKey facts Ezetimibe Atorvastatin calcium Cardiovascular diseasesP/0018/2012EMEA-001204-PIP01-11 … specific waiver for ezetimibe / atorvastatin (calcium) (EMEA-001204- PIP01-11 … specific waiver for ezetimibe / atorvastatin (calcium) (EMEA-001204- PIP01-11 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001085-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/04/2011, Last updated: 12/05/2011, Compliance check: XKey facts Atorvastatin calcium Amlodipine besilate … for amlodipine (besylate) / atorvastatin (calcium) (EMEA- 001085-PIP01-10 … for amlodipine (besylate) / atorvastatin (calcium) (EMEA- 001085-PIP01-10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, Atorvastatin, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002416-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 29/01/2019, Last updated: 25/04/2019, Compliance check: XKey facts Ramipril Atorvastatin amlodipine Cardiovascular … specific waiver for ramipril / atorvastatin / amlodipine (EMEA-002416-PIP01-18 … Ramipril Atorvastatin amlodipine …