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Updated 04 Jul 2026 · HPRA open data

Samsung Bioepis NL B.V. — Licensed Medicines

20 medicines held by Samsung Bioepis NL B.V. on the Irish market, from the HPRA register of authorised products.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0–9
← All medicines · 20 products held by Samsung Bioepis NL B.V.
MedicineActive substanceLicence holderStatus
Aybintio 25 mg/ml concentrate for solution for infusion
EU/1/20/1454/001
 Bevacizumab Samsung Bioepis NL B.V. —
Aybintio 25 mg/ml concentrate for solution for infusion
EU/1/20/1454/002
 Bevacizumab Samsung Bioepis NL B.V. —
Benepali 25 mg solution for injection in pre-filled syringe
EU/1/15/1074/005-007
 Etanercept Samsung Bioepis NL B.V. —
Benepali 50 mg solution for injection in pre-filled pen
EU/1/15/1074/002
 Etanercept Samsung Bioepis NL B.V. —
Benepali 50 mg solution for injection in pre-filled syringe
EU/1/15/1074/001
 Etanercept Samsung Bioepis NL B.V. —
Byooviz 10 mg/ml solution for injection
EU/1/21/1572/001
 Ranibizumab Samsung Bioepis NL B.V. —
Epysqli 300 mg concentrate for solution for infusion
EU/1/23/1735/001
 Eculizumab Samsung Bioepis NL B.V. —
Flixabi 100 mg powder for concentrate for solution for infusion
EU/1/16/1106/001
 Infliximab Samsung Bioepis NL B.V. —
Imraldi 40 mg solution for injection in pre-filled pen
EU/1/17/1216/005-008
 Adalimumab Samsung Bioepis NL B.V. —
Imraldi 40 mg solution for injection in pre-filled syringe
EU/1/17/1216/001-004
 Adalimumab Samsung Bioepis NL B.V. —
Imraldi 40 mg/0.8 ml solution for injection
EU/1/17/1216/009
 Adalimumab Samsung Bioepis NL B.V. —
Obodence 60 mg solution for injection in pre-filled syringe
EU/1/24/1890/001
 Denosumab Samsung Bioepis NL B.V. —
Ontruzant 150 mg Powder for concentrate for solution for infusion
EU/1/17/1241/001
 Trastuzumab Samsung Bioepis NL B.V. —
Opuviz 40 mg/mL solution for injection in a vial
EU/1/24/1865/001-002
 Aflibercept Samsung Bioepis NL B.V. —
Pyzchiva 130 mg concentrate for solution for infusion
EU/1/24/1801/003
 Ustekinumab Samsung Bioepis NL B.V. —
Pyzchiva 45 mg solution for injection in pre-filled pen
EU/1/24/1801/004
 Ustekinumab Samsung Bioepis NL B.V. —
Pyzchiva 45 mg solution for injection in pre-filled syringe
EU/1/24/1801/001
 Ustekinumab Samsung Bioepis NL B.V. —
Pyzchiva 90 mg solution for injection in pre-filled pen
EU/1/24/1801/005
 Ustekinumab Samsung Bioepis NL B.V. —
Pyzchiva 90 mg solution for injection in pre-filled syringe
EU/1/24/1801/002
 Ustekinumab Samsung Bioepis NL B.V. —
Xbryk 120 mg solution for injection
EU/1/24/1889/001-002
 Denosumab Samsung Bioepis NL B.V. —
Cite this database

Priya Life Science (2026). Irish Medicines Database. Available at: https://priyalifescience.com/medicines (Accessed: 6 July 2026).

Data: Health Products Regulatory Authority (HPRA) open dataset (“Authorised or Transfer Pending Products”), licensed CC BY 4.0, refreshed daily. Regulatory information only — not medical advice.