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Products Licensed in the US

I.  Products Licensed in the US to Treat Hemophilia A

  A.  Recombinant Factor VIII Products
  B.  Recombinant Humanized Bispecific FIXa and FX directed monoclonal antibody for use in patients with inherited hemophilia A
  C.  Human Plasma-Derived Immunoaffinity-purified Factor VIII Concentrates
  D.  Human Plasma-derived Concentrates that Contain Factor VIII and Von Willebrand Factor
  E.  Desmopressin Formulations to Treat Mild Hemophilia A

II.  Products Licensed in the US to Treat Hemophilia B
  A.  Recombinant Factor IX Concentrates
  B.  Human Plasma-derived Coagulation Factor IX Concentrates

III.  Products Licensed in the US to Treat Von Willebrand Disease
  A.  Desmopressin Formulations to Treat Type 1 and Type 2 VWD
  B.  Recombinant Von Willebrand Factor
  C.  Human Plasma-derived Concentrates that Contain Factor VIII and Von Willebrand Factor

IV.  Bypassing Agents (BPA) Licensed in the US to Treat Patients with Inherited Hemophilia A or B and Inhibitors
  A.  Human Plasma-derived Activated Prothrombin Complex Concentrate for Use in Patient with Inherited Hemophilia A or B and Inhibitors to Factor VIII or IX
  B.  Recombinant Factor VIIa Concentrate for Use in Patients with Inherited Hemophilia A or B and Inhibitors to Factor VIII or IX
  C.  Recombinant Humanized Bispecific FIXa and FX directed monoclonal antibody for Use in Patients with Inherited Hemophilia A and Inhibitors to Factor VIII

V.  Products Licensed in the US to Treat Non-congenital Hemophilia Patients with Acquired Hemophilia A
  A.  Recombinant Factor Concentrates for use in patients with Acquired Inhibitors to Factor VIII

VI.  Products Licensed in the US to Treat Rare Bleeding Disorders
  A.  Human Plasma-derived Concentrate to Treat Afibrinogenemia and Hypofibrinogenemia (Factor 1 deficiency)
  B.  Recombinant Factor VIIa Concentrate for Treatment of Factor VII Deficiency
  C.  Human Plasma-derived Concentrate to Treat Factor X Deficiency
  D.  Human Plasma-Derived Concentrate to Treat Factor XIII Deficiency
  E.  Recombinant Factor XIII-A Subunit Deficiency
  F.  Human Plasma-derived Prothrombin Complex Concentrates for Use in Patients with Factor II or Factor X Deficiency

VII.  Factor Products Licensed in the US for Use in Individuals with Thrombosis Risk
  A.  Products to Treat Antithrombin Deficiency
  B.  Human Plasma-derived Protein C Concentrate to Treat Protein C Deficiency

VIII.  Blood Bank Components Licensed in the US to Treat Rare Bleeding Disorders
  A.  Fresh Frozen Plasma Products to Treat Patients with Factor V or Factor XI Deficiency
  B.  Cryoprecipitate to Treat Patients with Dysfibrinogenemia

IX.  Antifibrinolytic Agents
  A.  Aminocaproic Acid
  B.  Tranexamic Acid

I.  Products Licensed in the US to Treat Hemophilia A
  A. Recombinant Factor VIII Products

 

Advate
Adynovate
Afstyla
Eloctate
Esperoct
Jivi
Kogenate FS
Kovaltry
NovoEight
Nuwig
Recombinate
Xyntha

I.  Products Licensed in the US to Treat Hemophilia A
  B. Recombinant Humanized Bispecific FIXa and FX directed monoclonal antibody for use in patients with inherited hemophilia A

 

Hemlibra

I.  Products Licensed in the US to Treat Hemophilia A
  C. Human Plasma-Derived Immunoaffinity-purified Factor VIII Concentrates

 

Hemofil M

I.  Products Licensed in the US to Treat Hemophilia A
  D. Human Plasma-derived Concentrates that Contain Factor VIII and Von Willebrand Factor

Alphanate
Humate-P
Koate-DVI      Grifols, distributed by Kedrion

I.  Products Licensed in the US to Treat Hemophilia A
  E. Desmopressin Formulations to Treat Mild Hemophilia A

 

DDAVP Injection      Aventis Pharma
Stimate Nasal Spray for Bleeding (PDF to come)

II.  Products Licensed in the US to Treat Hemophilia B
  A. Recombinant Factor IX Concentrates

 

Alprolix
Benefix
Idelvion
Ixinity
Rebinyn
Rixubis

II.  Products Licensed in the US to Treat Hemophilia B
  B. Human Plasma-derived Coagulation Factor IX Concentrates

 

AlphaNine SD (PDF to come)
Mononine (PDF to come)

III.  Products Licensed in the US to Treat Von Willebrand Disease
  A. Desmopressin Formulations to Treat Type 1 and Type 2 VWD

DDAVP Injection      Aventis Pharma
Stimate Nasal Spray for Bleeding      CSL Behring

 

III.  Products Licensed in the US to Treat Von Willebrand Disease
  B.  Recombinant Von Willebrand Factor

Vonvendi

III.  Products Licensed in the US to Treat Von Willebrand Disease
  C.  Human Plasma-derived Concentrates that Contain Factor VIII and Von Willebrand Factor

Alpanate
Humate-P
Wilate

IV.  Bypassing Agents (BPA) Licensed in the US to Treat Patients with Inherited Hemophilia A or B and Inhibitors
  A.  Human Plasma-derived Activated Prothrombin Complex Concentrate for Use in Patient with Inherited Hemophilia A or B and Inhibitors to Factor VIII or IX

Feiba

IV.  Bypassing Agents (BPA) Licensed in the US to Treat Patients with Inherited Hemophilia A or B and Inhibitors
  B.  Recombinant Factor VIIa Concentrate for Use in Patients with Inherited Hemophilia A or B and Inhibitors to Factor VIII or IX

NovoSeven RT

IV.  Products Licensed in the US to Treat Patients with Inherited Hemophilia A and Inhibitors
  C.  Recombinant Humanized Bispecific FIXa and FX directed monoclonal antibody for Use in Patients with Inherited Hemophilia A and Inhibitors to Factor VIII

Hemlibra

V.  Products Licensed in the US to Treat Non-congenital Hemophilia Patients with Acquired Hemophilia A
  A.  Recombinant Factor Concentrates for use in patients with Acquired Inhibitors to Factor VIII

NovoSeven RT (rhFVIIa)
Obizur (porcine rpFVIII)

VI.  Products Licensed in the US to Treat Rare Bleeding Disorders
  A.  Human Plasma-derived Concentrate to Treat Afibrinogenemia and Hypofibrinogenemia (Factor 1 deficiency)

RiaSTAP

 

VI.  Products Licensed in the US to Treat Rare Bleeding Disorders
  B.  Recombinant Factor VIIa Concentrate for Treatment of Factor VII Deficiency

NovoSeven RT

 

VI.  Products Licensed in the US to Treat Rare Bleeding Disorders
  C.  Human Plasma-derived Concentrate to Treat Factor X Deficiency

Coagadex

 

VI.  Products Licensed in the US to Treat Rare Bleeding Disorders
  D.  Human Plasma-Derived Concentrate to Treat Factor XIII Deficiency

Corifact

 

VI.  Products Licensed in the US to Treat Rare Bleeding Disorders
  E.  Recombinant Factor XIII-A Subunit Deficiency

Tretten

 

VI.  Products Licensed in the US to Treat Rare Bleeding Disorders
  F.  Human Plasma-derived Prothrombin Complex Concentrates for Use in Patients with Factor II or Factor X Deficiency

Bebulin      Shire (Takeda)
Profilnine (PDF to come)

 

VIII.  Factor Products Licensed in the US for Use in Individuals with Thrombosis Risk
  A.  Products to Treat Antithrombin Deficiency

ATryn
Thrombate      Grifols

 

VII.  Factor Products Licensed in the US for Use in Individuals with Thrombosis Risk
  B.  Human Plasma-derived Protein C Concentrate to Treat Protein C Deficiency

Ceprotin

 

VIII.  Blood Bank Components Licensed in the US to Treat Rare Bleeding Disorders
  A.  Fresh Frozen Plasma Products to Treat Patients with Factor V or Factor XI Deficiency

Donor Retested Fresh Frozen Plasma
Octaplas, frozen pooled plasma, blood group specific

 

VIII.  Blood Bank Components Licensed in the US to Treat Rare Bleeding Disorders
  B.  Cryoprecipitate to Treat Patients with Dysfibrinogenemia

Cryoprecipitate      Some Community Blood Centers
Cryoprecipitate, pooled      Some Community Blood Centers

 

IX.  Antifibrinolytic Agents
  A.  Aminocaproic Acid

Aminocaproic Acid
Amicar (oral) Xanodyne
Amicar (tablet) Xanodyne
Amicar (IV) American Regent Hospira

IX.  Antifibrinolytic Agents
  B.  Tranexamic Acid

Cyklokapron Pfizer
Lysteda Xanodyne