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Medicines
United States
Coagulation factor ix

FDA 1990

Coagulation factor ix

Alphanine, Alphanine Hp, Alphanine Sd

1000IU InjectionUnited StatesMarketedAuthorised 31 Dec 1990

Ask Osler about it

On this page

In other countries
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

Alphanine PWS Inj 1500UNIT/VialCanada · 1500 UNIT / VIAL · Powder For Solution · Alpha Therapeutic CorporationSame brand
AlphanineItaly · Polvere e solvente per soluzione per infusione endovenosa · Grifols Italia S.P.A.Same brand
ALPHANINE SD FOR INJECTION 1000 iu/vialSingapore · 1000 iu per 10ml vial · injection, powder, for solution · Grifols Asia Pacific Pte. LTD.Same brand
ALPHANINE SD FOR INJECTION 1500 iu/vialSingapore · 1500 iu per 10ml vial · injection, powder, for solution · Grifols Asia Pacific Pte. LTD.Same brand
ALPHANINE SD FOR INJECTION 500 iu/vialSingapore · 500 iu per 10ml vial · injection, powder, for solution · Grifols Asia Pacific Pte. LTD.Same brand
Alprolix 1.000 Ui Polvo y Disolvente Para Solucion InyectableSpain · 1000 UI · polvo y disolvente para solución inyectable · Swedish Orphan Biovitrum Ab (Publ)

More with the same substance on this register

Alphanine, Alphanine Hp, Alphanine SdCoagulation factor ix · 1500IU · InjectionUnited States
Alphanine, Alphanine Hp, Alphanine SdCoagulation factor ix · 500IU · InjectionUnited States

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same form

🇪🇸Alprolix 2.000 Ui Polvo y Disolvente Para Solucion InyectableSpain · 2000 UI · polvo y disolvente para solución inyectable · Swedish Orphan Biovitrum Ab (Publ)Same form

🇪🇸Alprolix 250 Ui Polvo y Disolvente Para Solucion InyectableSpain · 250 UI · polvo y disolvente para solución inyectable · Swedish Orphan Biovitrum Ab (Publ)Same form

🇭🇷Immunine 600 IU prašak i otapalo za otopinu za injekciju/infuzijuCroatia · Prašak i otapalo za otopinu za injekciju / infuziju · Baxalta Innovations GmbH, Industriestrasse 67, Beč, AustrijaSame form

🇭🇷Octanine F 100 IU/ml prašak i otapalo za otopinu za injekcijuCroatia · prašak i otapalo za otopinu za injekciju · Jana Pharm d.o.o., Lopašićeva 6, Zagreb, HrvatskaSame form

🇭🇷Immunine 1200 IU prašak i otapalo za otopinu za injekciju/infuzijuCroatia · Prašak i otapalo za otopinu za injekciju / infuziju · Baxalta Innovations GmbH, Industriestrasse 67, Beč, AustrijaSame form

🇮🇹AimafixItaly · Polvere e solvente per soluzione per infusione endovenosa · Kedrion S.P.A.Same form

🇮🇹AlprolixItaly · Polvere e solvente per soluzione iniettabile · Swedish Orphan Biovitrum AB (Publ)Same form

🇳🇱Alprolix 1000 IU, poeder en oplosmiddel voor oplossing voor injectieNetherlands · Poeder en oplosmiddel voor oplossing voor injectie · Swedish Orphan Biovitrum AB (publ)Same form

🇳🇱Alprolix 2000 IU, poeder en oplosmiddel voor oplossing voor injectieNetherlands · Poeder en oplosmiddel voor oplossing voor injectie · Swedish Orphan Biovitrum AB (publ)Same form

🇳🇱Alprolix 250 IU, poeder en oplosmiddel voor oplossing voor injectieNetherlands · Poeder en oplosmiddel voor oplossing voor injectie · Swedish Orphan Biovitrum AB (publ)Same form

🇳🇿AlprolixNew Zealand · Inj 250 iu vialSame form

🇳🇿AlprolixNew Zealand · Inj 4,000 iu vialSame form

🇳🇿AlprolixNew Zealand · Inj 3,000 iu vialSame form

🇷🇴Alprolix 1000 UiRomania · 1000UI · pulb+solv. pt. sol. inj. · Swedish Orphan Biovitrum ABSame form

🇷🇴Alprolix 2000 UiRomania · 2000UI · pulb+solv. pt. sol. inj. · Swedish Orphan Biovitrum ABSame form

🇷🇴Alprolix 250 UiRomania · 250UI · pulb+solv. pt. sol. inj. · Swedish Orphan Biovitrum ABSame form

🇷🇸Alprolix®Serbia · 250i.j. · prašak i rastvarač za rastvor za injekciju · Providens D.O.O., BeogradSame form

🇷🇸Alprolix®Serbia · 2000i.j. · prašak i rastvarač za rastvor za injekciju · Providens D.O.O., BeogradSame form

🇷🇸Alprolix®Serbia · 500i.j. · prašak i rastvarač za rastvor za injekciju · Providens D.O.O., BeogradSame form

🇸🇦ALPROLIX 1000 I.U Powder And Solvent For Solution For InjectionSaudi Arabia · Vetter Pharma-Fertigung GMBH & Co. KGSame form

🇸🇦ALPROLIX 2000 I.U Powder And Solvent For Solution For InjectionSaudi Arabia · Vetter Pharma-Fertigung GMBH & Co. KGSame form

🇸🇦ALPROLIX 250 I.U Powder And Solvent For Solution For InjectionSaudi Arabia · Vetter Pharma-Fertigung GMBH & Co. KGSame form

🇨🇦AlprolixCanada · 2000 UNIT / VIAL · Kit, Powder For Solution · Sanofi-Aventis Canada INCSame substance

🇨🇦AlprolixCanada · 500 UNIT / VIAL · Kit, Powder For Solution · Sanofi-Aventis Canada INCSame substance

🇪🇺AlprolixEuropean Union · Swedish Orphan Biovitrum AB (publ)Same substance

🇪🇺BeneFIXEuropean Union · Pfizer Europe MA EEIGSame substance

🇪🇺IdelvionEuropean Union · CSL Behring GmbHSame 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: Coagulation factor ix
Strength: 1000IU
Dosage form: Injection
Route: Intravenous
Register: United States (FDA)
Status: Marketed
Status in the register: Licensed / Rx
Authorised: 31 Dec 1990
Registration: BLA 103249
Marketing authorisation holder: Grifols Biologicals LLC
Procedure: 351(a)
Supply: Rx

FDABenefixCoagulation factor ix · 500IU/ML · For Injection🇺🇸United States

FDABenefixCoagulation factor ix · 3000IU/ML · For Injection🇺🇸United States

FDABenefixCoagulation factor ix · 2000IU/ML · For Injection🇺🇸United States

FDABenefixCoagulation factor ix · 250IU/ML · For Injection🇺🇸United States

FDABenefixCoagulation factor ix · 1000IU/ML · For Injection🇺🇸United States

FDAIdelvionCoagulation factor ix · 1000IU · For Injection🇺🇸United States

FDAIdelvionCoagulation factor ix · 2000IU · For Injection🇺🇸United States

FDAIdelvionCoagulation factor ix · 250IU · For Injection🇺🇸United States

FDAIdelvionCoagulation factor ix · 3500IU · For Injection🇺🇸United States

FDAIdelvionCoagulation factor ix · 500IU · For Injection🇺🇸United States