There is on-going development of generic EU CTD Dossier of Irbesartan-hydrochlorothiazide, filmcoated tablets, 150+12.5/300+12.5 mg.
Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.
As with all angiotensin II receptor antagonists, irbesartan is indicated for the treatment of hypertension. Irbesartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, hypertension and microalbuminuria (>30 mg/24 hours) or proteinuria (>900 mg/24 hours).
Irbesartan is also available in a combination formulation with a low dose thiazide diuretic, invariably hydrochlorothiazide, to achieve an additive antihypertensive effect. Irbesartan/hydrochlorothiazide combination preparations are marketed under similar trade names to irbesartan preparations, including Irda, CoIrda, CoAprovel, Karvezide, Avalide and Avapro HCT.
More details at: http://www.rxlist.com/avalide-drug.htm.
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