Irish Medicines Database · HPRA register

Flebogamma DIF 50 mg/ml solution for infusion

Authorisation EU/1/07/404/1-5 · Instituto Grifols S.A.

Licence EU/1/07/404/1-5 · Unknown

Licence holder: Instituto Grifols S.A. (all products →)
Active substance: Human normal immunoglobulin
Dosage form: Solution for infusion
Route of administration: Intravenous use
ATC codes: J06BA, J06BA02
First authorised: 23/08/2007
Prescription status: Product subject to prescription which may not be renewed (A)
Supply: Supply through pharmacies only
Legal basis: Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 16 Sep 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.