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Opinion/decision on a Paediatric investigation plan (PIP): Taxotere, docetaxel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: Docetaxel, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate and solvent for solution for infusion
Decision date: 16/05/2008, Last updated: 04/06/2008, Compliance check: XDocetaxel Oncology … Docetaxel … Word - Decision and Opinon docetaxel 0000029-PIP01-07 to be publi… … -
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Opinion/decision on a Paediatric investigation plan (PIP): Telmisartan, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000045-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 01/02/2008, Last updated: 15/02/2008, Compliance check: XActive substance Telmisartan Ramipril Therapeutic area Cardiovascular … and/or distribution of this document is authorised for non-commercial … EMEA is acknowledged Doc. Ref.:EMEA/43360/2008 P/3/2008 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, Indapamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002081-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 05/05/2017, Last updated: 04/07/2017, Compliance check: XActive substance Ramipril Indapamide Therapeutic area … product specific waiver for ramipril / indapamide (EMEA-002081-PIP01-16 … product specific waiver for ramipril / indapamide (EMEA-002081-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001871-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/02/2016, Last updated: 22/04/2016, Compliance check: XKey facts Ramipril amlodipine Cardiovascular … product specific waiver for ramipril / amlodipine (EMEA-001871-PIP01-15 … product specific waiver for ramipril / amlodipine (EMEA-001871-PIP01-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/0323/2014, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/12/2014, Last updated: 23/02/2015, Compliance check: XKey facts amlodipine Ramipril Cardiovascular diseasesP/0323/2014P/0323/2014 … specific waiver for amlodipine / ramipril (EMEA-001685-PIP01-14) PDF … product-specific waiver: Amlodipine / ramipril for treatment of hypertension … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001464-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 30/07/2013, Last updated: 03/09/2013, Compliance check: XKey facts amlodipine Ramipril Cardiovascular diseasesP/0180/2013EMEA-001464-PIP01-13 … product-specific waiver for amlodipine / ramipril (EMEA-001464-PIP01-13) PDF … specific waiver for amlodipine / ramipril (EMEA-001464-PIP01-13) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000887-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 28/07/2010, Last updated: 26/08/2010, Compliance check: XKey facts amlodipine Ramipril Cardiovascular diseasesP/136/2010EMEA-000887-PIP01-10 … specific waiver for amlodipine/ramipril (EMEA-000887-PIP01-10) in … specific waiver for amlodipine/ramipril (EMEA-000887-PIP01-10) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002569-PIP04-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: XKey facts Rosuvastatin Ramipril Cardiovascular diseasesP/0343/2019EMEA-002569-PIP04-19 … waiver for rosuvastatin / ramipril (EMEA-002569-PIP01-19) PDF … Rosuvastatin Ramipril … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002569-PIP04-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: XKey facts Rosuvastatin Ramipril Cardiovascular diseasesP/0343/2019EMEA-002569-PIP04-19 … waiver for rosuvastatin / ramipril (EMEA-002569-PIP01-19) PDF … Rosuvastatin Ramipril … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, bisoprolol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002531-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: XActive substance Ramipril bisoprolol Therapeutic area … Ramipril bisoprolol … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001942-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 12/08/2016, Last updated: 28/10/2016, Compliance check: XKey facts Ramipril amlodipine hydrochlorothiazide … product specific waiver for ramipril / amlodipine / hydrochlorothiazide … product specific waiver for ramipril / amlodipine / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine besilate, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001607-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/06/2014, Last updated: 22/07/2014, Compliance check: XKey facts Amlodipine besilate Ramipril Cardiovascular diseasesP/0154/2014EMEA-001607-PIP01-13 … for amlodipine besilate / ramipril (EMEA-001607-PIP01-13) PDF … for amlodipine besilate / ramipril (EMEA-001607-PIP01-13) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, 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-001560-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/03/2014, Last updated: 16/04/2014, Compliance check: XKey facts BR/AM Ramipril Amlodipine besilate Cardiovascular … for amlodipine (besylate) / ramipril (EMEA-001560-PIP01-13) PDF … for amlodipine (besylate) / ramipril (EMEA-001560-PIP01- 13) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, 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-001471-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 24/09/2013, Last updated: 15/11/2013, Compliance check: XKey facts Ramipril Amlodipine besilate Cardiovascular … product specific waiver for ramipril / amlodipine (besilate) (EMEA-001471-PIP01-13 … product specific waiver for ramipril / amlodipine (besilate) (EMEA-001471-PIP01- 13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, hydrochlorothiazide, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002906-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/03/2021, Last updated: 09/11/2021, Compliance check: Xamlodipine hydrochlorothiazide Ramipril Cardiovascular diseasesP/0085/2021EMEA-002906-PIP01-20 … hydrochlorothiazide / amlodipine / ramipril (EMEA- 002906-PIP01-20) PDF … hydrochlorothiazide / amlodipine / ramipril (EMEA- 002906-PIP01-20) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, Bisoprolol fumarate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002860-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 22/12/2020, Last updated: 22/09/2021, Compliance check: XKey facts Ramipril Bisoprolol fumarate Cardiovascular … product specific waiver for ramipril / bisoprolol (fumarate) (EMEA-002860-PIP01 … product specific waiver for ramipril / bisoprolol (fumarate) (EMEA-002860-PIP01- 20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, Bisoprolol fumarate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002794-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/10/2020, Last updated: 22/07/2021, Compliance check: XKey facts Ramipril Bisoprolol fumarate Cardiovascular … product specific waiver for ramipril / bisoprolol (fumarate) (EMEA-002794-PIP01-20 … product specific waiver for ramipril / bisoprolol (fumarate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003005-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/08/2021, Last updated: 12/09/2022, Compliance check: XKey facts Ramipril amlodipine hydrochlorothiazide … product specific waiver for ramipril / amlodipine / hydrochlorothiazide … product specific waiver for ramipril / amlodipine / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine (as besylate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003070-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 03/12/2021, Last updated: 14/03/2023, Compliance check: XKey facts Ramipril amlodipine (as besylate … product specific waiver for ramipril / amlodipine (besilate … product specific waiver for ramipril / amlodipine (besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bisoprolol fumarate, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002560-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/07/2019, Last updated: 13/11/2019, Compliance check: XKey facts Bisoprolol fumarate Ramipril Cardiovascular diseasesP/0254/2019EMEA-002560-PIP01-19 … for bisoprolol fumarate / ramipril, (EMEA-002560-PIP01-19) PDF … Bisoprolol fumarate Ramipril … -
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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: XActive substance Ramipril atorvastatin amlodipine Therapeutic … Ramipril atorvastatin amlodipine … -
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Opinion/decision on a Paediatric investigation plan (PIP): simvastatin, Ramipril, acetyl salicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000631-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 27/11/2009, Last updated: 23/12/2009, Compliance check: XKey facts simvastatin Ramipril acetyl salicylic acid Cardiovascular … waiver for simvastatin / ramipril / acetyl salicylic acid (EMEA-000631-PIP01-09 … 000631-PIP01-09 for publishing.doc European Medicines … -
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Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin, Ramipril, acetyl salicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001342-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 22/10/2012, Last updated: 27/11/2012, Compliance check: XActive substance atorvastatin Ramipril acetyl salicylic acid Therapeutic … waiver for atorvastatin / ramipril / acetyl salicylic acid (EMEA-001342-PIP01-12 … waiver for atorvastatin / ramipril / acetyl salicylic acid (EMEA- 001342-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Docosahexaenoic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002808-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 12/02/2021, Last updated: 08/10/2021, Compliance check: XKey facts Docosahexaenoic acid OphthalmologyP/0058/2021EMEA-002808-PIP01-20 … granting of a waiver for docosahexaenoic acid (EMEA-002808-PIP01-20 … granting of a waiver for docosahexaenoic acid (EMEA-002808-PIP01-20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: Xeicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of … eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of … eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of …