226 results
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Referral: Cozaar
losartan, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/04/2008, EC decision date: 03/09/2008, Last updated: 25/09/2008II) receptor antagonist, losartan, acting on the AT1 receptor … angiotensin system (RAS) cascade. Losartan is indicated for the treatment … treatment of hypertension. Losartan may also delay progression … -
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Orphan designation: losartan for: Treatment of epidermolysis bullosa
Date of designation: 26/02/2019, Positive, Last updated: 07/03/2022losartan Overview On 26 February 2019 … Consulting GmbH, Germany, for losartan for the treatment of epidermolysis … transferred to Crowd Pharma Losartan GmbH & Co. KG, Germany, in … -
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Orphan designation: losartan for: Treatment of osteogenesis imperfecta
Date of designation: 21/06/2022, Positive, Last updated: 15/09/2022losartan Overview This medicine was … easily, often from mild trauma. Losartan binds to the angiotensin-II … 14 2.2.3. losartan - EMA/OD/0000075685 … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, losartan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001380-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/02/2013, Last updated: 23/04/2013, Compliance check: XKey facts amlodipine losartan Cardiovascular diseasesP/0040/2013EMEA-001380-PIP01-12 … product-specific waiver for amlodipine / losartan (EMEA-001380-PIP01-12) PDF … specific waiver for amlodipine / losartan (EMEA-001380-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000008-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 29/02/2008, Last updated: 19/03/2008, Compliance check: V, 06/02/2009Key facts Losartan potassium Cardiovascular … Cozaar and associated names, losartan potassium EMEA-000008-PIP01-07 … Word - Decision and Opinion losartan 000008-PIP01-07 European … -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium, 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-001390-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/04/2013, Last updated: 31/05/2013, Compliance check: XKey facts Losartan potassium Amlodipine besilate … for amlodipine (besilate) / losartan (potassium) (EMEA-001390-PIP01-12 … for amlodipine (besilate) / losartan (potassium) (EMEA- 001390-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine camsylate, Losartan potassium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000886-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/09/2010, Last updated: 29/10/2010, Compliance check: Xfacts Amlodipine camsylate Losartan potassium Cardiovascular … for amlodipine camsylate / losartan potassium (EMEA-000886-PIP01-10 … 000886-PIP01-10 Decision Losartan potassium, Amlodipine camsylate 7 … -
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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 … candesartan, irbesartan, losartan, olmesartan, valsartan … candesartan, irbesartan, losartan, olmesartan, valsartan … -
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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: Cozaar Comp
Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/04/2008, EC decision date: 03/09/2008, Last updated: 25/09/2008fixed dose combination of losartan and hydrochlorothiazide Losartan is an orally active angiotensin … antihypertensive agent. The losartan/hydrochlorothiazide combination is indicated … and associated names, INN-losartan + hydrochlorothiazide … -
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Press release: Valsartan: review of impurities extended to other sartan medicines
CHMP, Last updated: 21/09/2018another active substance, losartan, made by Hetero Labs in India … candesartan, irbesartan, losartan and olmesartan. Like valsartan … seen so far in one batch of losartan from Hetero Labs, there is … -
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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: 15/10/2018levels of NDEA were found in losartan made by Hetero Labs in India … -
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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 … -
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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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Press release: Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
CHMP, Last updated: 01/02/2019Losartan (150 mg) 96.0 … -
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National expert: Michela Piezzo, Italian Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 23.43 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 Survival … -
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Press release: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
PRAC, Last updated: 11/04/2014candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan or … candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan … -
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Press release: European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive
CHMP, Last updated: 20/10/2011candesartan, eprosartan, irbesartan, losartan, olmesartan, valsartan and … eprosartan, irbesartan, losartan, olmesartan, valsartan and … candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan and … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
CHMP, Last updated: 21/09/2018another active substance, losartan, made by Hetero Labs in India … candesartan, irbesartan, losartan and olmesartan. For more … -
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National expert: Maja Lusina Kregar, Agency For Medicinal Products And Medical Devices Of Croatia (updated)
- Declaration of interests - 80.08 KB | PDF
- Curriculum Vitae - 17.75 KB | PDF
Musulin N. Stability study of losartan/hydrochlorothiazide tablets. Int J Pharm 291 … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 April 2008
CHMP, Last updated: 29/04/2008mg film-coated tablets, (losartan potassium), from Merck Sharp … -
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National expert: Kyrre Eeg Emblem, European Medicines Agency (updated)
- Declaration of interests - 81.29 KB | PDF
- Curriculum Vitae - 35.97 KB | PDF
Reserach Council) research on losartan in adult patients with glioblastoma … -
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Press release: Combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted – CHMP endorses PRAC recommendation
CHMP, Last updated: 23/05/2014candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan or … -
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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: 19/11/2018candesartan, irbesartan, losartan and olmesartan. The review … -
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National expert: Jonas Bøje Nielsen, Danish Medicines Agency (updated)
- Declaration of interests - 80.8 KB | PDF
- Curriculum Vitae - 18.74 KB | PDF
Christensen S. and Jonassen T.E.N. Losartan Decreases Vasopressin-Mediated …