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Irish Medicines Database · HPRA register

Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets

Authorisation EU/1/09/574/13-24 · Novartis Europharm Limited

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Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
Licence EU/1/09/574/13-24 · Unknown
Licence holder
Novartis Europharm Limited (all products →)
Active substances
Hydrochlorothiazide, Valsartan, Amlodipine besilate
Dosage form
Film-coated tablet
Route of administration
Oral use
ATC codes
C09DX, C09DX01
First authorised
04/11/2009
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Fixed combination application (Article 10b of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.