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Product No EMEA/H/C/002676
Brand Name Actelsar HCT
Nonproprietary Name telmisartan / hydrochlorothiazide
API telmisartan / hydrochlorothiazide
ATC Code C09DA07
Indications 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.
Orphan Drug no
Generics yes
Marketing Authorization Holder Actavis Group hf
Status Authorised
Authorization Date 2013-03-13
Version 4
Condition Approval no
Exceptions no
Biosimilar no
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