217 results
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001914-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Olmesartan medoxomil rosuvastatin calcium Cardiovascular … product specific waiver for olmesartan medoxomil) / rosuvastatin (calcium … product specific waiver for olmesartan medoxomil) / rosuvastatin (calcium … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, 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-001538-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … for amlodipine (besilate) / olmesartan medoxomil) (EMEA-001538-PIP01-13) PDF … for amlodipine (besilate) / olmesartan medoxomil) (EMEA-001538-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, 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-001852-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/11/2015, Last updated: 07/01/2016, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … product specific waiver for olmesartan medoxomil / amlodipine (besilate) (EMEA-001852-PIP01-15 … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/228/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/226/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/227/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, hydrochlorothiazide, 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-002104-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: XActive substance Olmesartan medoxomil hydrochlorothiazide Amlodipine … product specific waiver for olmesartan medoxomil / amlodipine (besilate … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
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Human medicine European public assessment report (EPAR): Edarbi
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011, Revision: 10, Authorised, Last updated: 17/03/2022Authorised azilsartan medoxomil Overview This is a summary … active substance azilsartan medoxomil. It is available as tablets … substance in Edarbi, azilsartan medoxomil, is an ‘angiotensin-II-receptor … -
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Human medicine European public assessment report (EPAR): Ipreziv
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011,
, Revision: 4, Withdrawn, Last updated: 19/12/2014
Withdrawn azilsartan medoxomil Overview The marketing authorisation … gt;IprezivEMEA/H/C/002517Azilsartan medoxomilazilsartan medoxomilHypertensionC09CA09 This medicine is under additional … for Ipreziv (azilsartan medoxomil) in the European Union (EU … -
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Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000237-PIP01-08-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules for oral suspension
Decision date: 03/12/2021, Last updated: 16/02/2023, Compliance check: XActive substance Azilsartan medoxomil Therapeutic area Cardiovascular … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M10 … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Azilsartan medoxomil, chlortalidone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001294-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/10/2012, Last updated: 27/11/2012, Compliance check: XKey facts Azilsartan medoxomil chlortalidone Cardiovascular … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294 … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294-PIP01-12 … -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014Actavis captopril imidapril zofenopril candesartan delapril telmisartan aliskiren moexipril enalapril valsartan fosinopril irbesartan perindopril quinapril ramipril eprosartan olmesartan trandolapril losartan azilsartan lisinopril spirapril benazepril cilazapril telmisartan hydrochlorothiazide telmisartan telmisartan telmisartan telmisartan amlodipine telmisartan amlodipine telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide amlodipine valsartan hydrochlorothiazide amlodipine … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021candesartan, irbesartan, losartan, olmesartan, valsartan) Questions … candesartan, irbesartan, losartan, olmesartan, valsartan) EMA/86733/2021 … candesartan, irbesartan, losartan, olmesartan, valsartan) EMA/86733/2021 … -
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Press release: Valsartan: review of impurities extended to other sartan medicines
CHMP, Last updated: 21/09/2018irbesartan, losartan and olmesartan. Like valsartan, these active … irbesartan, losartan and olmesartan. Like valsartan, these active … Candesartan, irbesartan, losartan, olmesartan and valsartan belong to a … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012
CHMP, Last updated: 14/12/2012Fenofibrato Pensa, Fenofibrato Ranbaxy INN fenofibrate … -
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News: Nitrosamines: EMA aligns recommendations for sartans with those for other medicines
CHMP, Last updated: 13/11/2020candesartan, irbesartan, losartan, olmesartan and valsartan, which belong … -
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Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018candesartan, irbesartan, losartan, olmesartan and valsartan, which belong … -
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Press release: Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
CHMP, Last updated: 01/02/2019Olmesartan (40 mg) 96.0 … -
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Press release: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
Last updated: 19/11/2018irbesartan, losartan and olmesartan. The review is being carried … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 2011
CHMP, Last updated: 23/09/2011application/pdf Edarbi azilsartan medoxomil Takeda Global Research and … application/pdf Ipreziv azilsartan medoxomil Takeda Global Research and … -
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Press release: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
PRAC, Last updated: 11/04/2014eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan … eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan … -
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Press release: European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive
CHMP, Last updated: 20/10/2011eprosartan, irbesartan, losartan, olmesartan, valsartan and telmisartan … eprosartan, irbesartan, losartan, olmesartan, valsartan and telmisartan … eprosartan, irbesartan, losartan, olmesartan, telmisartan and valsartan … -
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Press release: EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan: EMA and national authorities considering impact on other active substances produced at the site
Last updated: 28/09/2018irbesartan, losartan and olmesartan. The review is being carried … -
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National expert: Michela Piezzo, Italian Medicines Agency (updated)
- Declaration of interests - 39.43 KB | PDF
- Curriculum Vitae - 33.62 KB | PDF
G, Martinelli C, Nuzzo F, Pensabene M, Laurentiis M. Targeting … Iodice G, Nuzzo F, Pacilio C, Pensabene M and De Laurentiis M. Progression_Free … -
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National expert: Jan Staessen, European Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 183.78 KB | PDF
2008), and the Randomized Olmesartan and Diabetes Microalbuminuria …