In other countries
The same active substances on other registers, the same brand first.
- Hepatect CP Solution for Infusion 50 IU/MLSingapore · 50 iu/ml · infusion, solution · Grifols Asia Pacific Pte. LTD.Same strength and form
- Imunoglobulin protiv hepatitisa B, ljudski, 250 IU, otopina za injekcijuCroatia · otopina za injekciju · Imunološki zavod d.d., Rockefellerova 2, Zagreb, HrvatskaSame form
- Imunoglobulin protiv hepatitisa B, ljudski, 500 IU, otopina za injekcijuCroatia · otopina za injekciju · Imunološki zavod d.d., Rockefellerova 2, Zagreb, HrvatskaSame form
- IgantibeItaly · Soluzione iniettabile · Instituto Grifols S.A.Same form
- ImmunohbsItaly · Soluzione iniettabile · Kedrion S.P.A.Same form
- KedhbsItaly · Soluzione iniettabile · Kedrion S.P.A.Same form
- Humaan hepatitis B-immunoglobuline Eureco-Pharma 180 IE/ml oplossing voor injectieNetherlands · Oplossing voor injectie · Eureco-Pharma B.V.Same form
- Uman Big 180 IE/ml oplossing voor injectieNetherlands · Oplossing voor injectie · Kedrion S.p.A.Same form
- ZutectraRomania · 500 UI · sol inj. in seringa pre-umpluta · Biotest Pharma GMBHSame form
- HyperHEP B INJECTIONSingapore · 15 - 18% · injection · Grifols Asia Pacific Pte. LTD.Same form
- HyperHEP B Pre-filled Syringe 0.5mLSingapore · 15-18% · injection · Grifols Asia Pacific Pte. LTD.Same form
- Hepagam BCanada · 312 UNIT / ML · Solution · Ki Biopharma LLCSame substance
- Hyperhep BCanada · 220 UNIT / ML · Solution · Grifols Therapeutics LLCSame substance
- Hyperhep BCanada · 220 UNIT / ML · Solution · Grifols Therapeutics LLCSame substance
- ZutectraEuropean Union · Biotest Pharma GmbHSame substance
- ImmunoGamEuropean Union · Cangene Europe LimitedSame substance
- Venbig 50 IU/ml prašak i otapalo za otopinu za infuzijuCroatia · prašak i otapalo za otopinu za infuziju · Kedrion S.p.A., Ai Conti, Castelvecchio Pascoli, Barga (Lucca), ItalijaSame substance
- HEPATECT CP 50 UI/mlRomania · 50 UI/ml · sol. perf. · Biotest Pharma GMBHSame substance
- HEPATECT CP 50 UI/mlRomania · 50 UI/ ml · sol. perf. · Biotest Pharma GMBHSame substance
- Hepatect CPSerbia · 50i.j./mL · rastvor za infuziju · Medis Pharma D.O.O. BeogradSame substance
- Hepatect CPSerbia · 50i.j./mL · rastvor za infuziju · Medis Pharma D.O.O. BeogradSame substance
- Hepatect CPSerbia · 50i.j./mL · rastvor za infuziju · Medis Pharma D.O.O. BeogradSame substance
- HepaGam BSaudi Arabia · Emergent BioSolutions Canada IncSame substance
- HepaGam BSaudi Arabia · Emergent BioSolutions Canada IncSame substance
- Hepatect CPSaudi Arabia · BiotestSame substance
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
U.S. Food and Drug Administration
FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.
Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Hepatitis b immunoglobulin
- Strength
- 220U/ML
- Dosage form
- Injection
- Route
- Intramuscular
- Register
- United States (FDA)
- Status
- Marketed
- Status in the register
- Licensed / Rx
- Authorised
- 23 Sept 1977
- Registration
- BLA 101146
- Marketing authorisation holder
- Grifols Therapeutics LLC
- Procedure
- 351(a)
- Supply
- Rx