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Kinzalkomb (telmisartan;hydrochlorothiazide)

Region
🇪🇺 EU
Active substance
telmisartan;hydrochlorothiazide
Company
Bayer AG
Status
Withdrawn
Therapeutic area
Hypertension
EU approval
Fri 19 Apr 2002
Application
EMEA/H/C/000415
ATC
C09DA07
Official record
www.ema.europa.eu

Indication

Treatment of essential hypertension. Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.