748 results
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Orphan designation: Mixture of two adeno-associated viral vectors of serotye 8 containing the 5'-half sequence of human ABCA4 gene and the 3'-half sequence of human ABCA4 gene for: Treatment of Stargardt's disease
Date of designation: 04/07/2014, Positive, Last updated: 07/11/20225'-half sequence of human ABCA4 gene and the 3'-half sequence … 3'-half sequence of human ABCA4 gene Overview On 4 July 2014 … 5'-half sequence of human ABCA4 gene and the 3'-half sequence … -
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Orphan designation: Lentiviral vector containing the human ABCA4 gene for: Treatment of Stargardt's disease (updated)
Date of designation: 02/02/2010, Positive, Last updated: 13/03/2023vector containing the human ABCA4 gene Overview On 2 February … vector containing the human ABCA4 gene for the treatment of … abnormalities in a gene called ABCA4. The … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lentiviral vector containing the human ABCA4 gene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-002407-PIP01-18, Route(s) of administration: Intraocular use, Pharmaceutical form(s): Solution for injection
Decision date: 14/06/2019, Last updated: 07/11/2019, Compliance check: Xvector containing the human ABCA4 gene OphthalmologyP/0213/2019EMEA-002407-PIP01-18 … vector containing the human ABCA4 gene (SAR422459) (EMEA-002407-PIP01-18 … vector containing the human ABCA4 gene … -
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Orphan designation: Adeno-associated viral vector serotype 5 containing the human ABCA4 gene for: Treatment of Stargardt's disease
Date of designation: 07/02/2009, Withdrawn, Last updated: 16/10/2014serotype 5 containing the human ABCA4 gene Overview Please note … serotype 5 containing the human ABCA4 gene for the treatment of … abnormalities in a gene called ABCA4. The … -
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Orphan designation: Allogeneic skin-derived ABCB5-positive mesenchymal stem cells for: Treatment of epidermolysis bullosa
Date of designation: 29/05/2019, Positive, Last updated: 09/08/2019Allogeneic skin-derived ABCB5-positive mesenchymal stem cells Overview … for allogeneic skin-derived ABCB5-positive mesenchymal stem cells (also … of allogeneic skin-derived ABCB5-positive mesenchymal stem cells have … -
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Orphan designation: Adeno-associated viral vector serotype 9 containing the human ABCD1 gene for: Treatment of adrenoleukodystrophy
Date of designation: 11/11/2022, Positive, Last updated: 25/01/2023serotype 9 containing the human ABCD1 gene Overview This medicine … serotype 9 containing the human ABCD1 gene … -
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Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA (elivaldogene autotemcel) for: Treatment of adrenoleukodystrophy
Date of designation: 06/06/2012, Withdrawn, Last updated: 04/04/2022Lenti-D encoding the human ABCD1 cDNA (elivaldogene autotemcel … Lenti-D encoding the human ABCD1 cDNA was authorised in the … Lenti-D encoding the human ABCD1 cDNA for the treatment of … -
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Orphan designation: Ramiprilat for: Treatment of Stargardt's disease
Date of designation: 12/03/2013, Positive, Last updated: 17/01/2023Ramiprilat Overview On 12 March 2013 … Iris Pharma, France, for ramiprilat for the treatment of Stargardt's … abnormalities in a gene called ABCA4. The … -
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Orphan designation: Combination of two adeno-associated viral vectors of serotype 8 containing the 5'- and the 3'- half coding sequences of human ABCA4 fused to inteins for: Treatment of Stargardt's disease
Date of designation: 17/10/2019, Positive, Last updated: 07/11/2022coding sequences of human ABCA4 fused to inteins Overview … coding sequences of human ABCA4 fused to inteins for the … abnormalities in a gene called ABCA4. The … -
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Referral: Vasotop P
ramipril, Article 13
Status: European Commission final decision, opinion/position date: 08/12/2009, EC decision date: 27/04/2010, Last updated: 14/08/2014contain the active ingredient ramipril at concentrations of 0.625 … and 2.5 mg respectively. Ramipril is an angiotensin-converting … to assess the efficacy of ramipril in cats to reduce systolic … -
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Referral: Tritace
ramipril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 24/04/2009active substance in Tritace, ramipril, is an angiotensin-converting … Protect Startset, Delix P, Ramipril Winthrop Ramipril Prevent, Loavel, Ramiwin Ramipril Medgenerics, Ramilich, Tritace … hard capsules containing ramipril 1.25 mg, 2.5 mg, 5 mg and … -
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Referral: Tritazide
ramipril, hydrochlorothiazide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 14/04/2009contains two active substances, ramipril and hydrochlorothiazide Ramipril is an angiotensin converting … adequately controlled with ramipril alone or hydrochlorothiazide … Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor … -
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Referral: Rambis and associated names (updated)
ramipril, bisoprolol fumarate, associated names: Ralbior, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 15/02/2023, Last updated: 08/03/2023authorisation of Rambis (ramipril / bisoprolol) in the EU On … combination of two medicines called ramipril and bisoprolol. Rambis contains … bisoprolol. Rambis contains both ramipril and bisoprolol and is intended … -
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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: XKey facts Ramipril indapamide Cardiovascular … 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): 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 … substance: Telmisartan / ramipril (fixed combination) Condition(s … telmisartan 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): 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 …