Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1664412
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Name of medicinal product:
|
ACTELSAR HCT
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Active substances:
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|
ATC code:
|
C09DA85
|
Dosage form:
|
tablet
|
Route of administration:
|
oral use
|
Strengh:
|
80mg+25mg
|
Amount in package:
|
14TK
|
Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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|
Additional information:
|
|
Indication:
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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
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Actavis Group Ptc ehf.
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Marketing authorization number:
|
EU/1/13/817
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Marketing authorization issued on:
|
March 15, 2013
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Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
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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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