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Irish Medicines Database · HPRA register

Besremi 500 microgram/0.5 ml Solution for injection in pre-filled pen

Authorisation EU/1/18/1352/002 · Aop Orphan Pharmaceuticals GmbH

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Besremi 500 microgram/0.5 ml Solution for injection in pre-filled pen
Licence EU/1/18/1352/002 · Unknown
Licence holder
Aop Orphan Pharmaceuticals GmbH (all products →)
Active substance
Ropeginterferon alfa-2b
Dosage form
Solution for injection in pre-filled syringe
Route of administration
Subcutaneous use
ATC code
L03AB15
First authorised
15/02/2019
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.