Actelsar HCT (telmisartan;hydrochlorothiazide)
- Region
- 🇪🇺 EU
- Active substance
- telmisartan;hydrochlorothiazide
- Company
- Actavis Group PTC ehf
- Status
- Authorised
- Therapeutic area
- Essential Hypertension
- CHMP opinion
- Thu 17 Jan 2013
- EU approval
- Wed 13 Mar 2013
- Designations
- Generic
- Application
- EMEA/H/C/002676
- ATC
- C09DA07
- Official record
- www.ema.europa.eu
Indication
Treatment of essential hypertension. Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults 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.