Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1610020
Name of medicinal product: ACTELSAR HCT
Active substances:
Estonian, English, Latin
ATC code: C09DA85
Dosage form: tablet
Route of administration: oral use
Strengh: 80mg+25mg
Amount in package: 56TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of essential hypertension. 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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Actavis Group Ptc ehf. 
Marketing authorization number: EU/1/13/817 
Marketing authorization issued on: March 15, 2013 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Entry/Changing date: January 4, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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