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Irish Medicines Database · HPRA register

AFSTYLA 2000 IU powder and solvent for solution for injection

Authorisation EU/1/16/1158/005 · CSL Behring GmbH

← All medicines

AFSTYLA 2000 IU powder and solvent for solution for injection

Licence EU/1/16/1158/005 · Unknown

Licence holder: CSL Behring GmbH (all products →)
Active substance: Lonoctocog alfa
Dosage form: Powder and solvent for solution for injection
Route of administration: Intravenous use
ATC codes: B02BD, B02BD02
First authorised: 04/01/2017
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 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.