Vaccines, Blood & Biologics
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Licensed Biological Products with Supporting Documents
| A | B | C | D | F | H | I | J | M | O | P | R | S | T | V | W | Y | Z |
The list below includes products for which we have supporting documentation. The list is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.
| A | ||
| Product | Trade Name | Manufacturer |
|---|---|---|
| Adenovirus Vaccine Live Oral Type 4 and Type 7 | None [Adenovirus Vaccine Live Oral Type 4 and Type 7] | Teva Women's Health, Inc./Barr Labs, Inc. |
| Albumin (Human) | None [Albumin (Human)] | Octapharma Pharmazeutika Produktionsgesm.b.H |
| Kedbumin [Albumin (Human) 25%] | Kedrion Biopharmaceuticals, SpA | |
| Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen | GINTUIT | Organogenesis Incorporated |
| Alpha1-Proteinase Inhibitor (Human) | Aralast NP | Baxter Healthcare Corporation |
| Aralast | Baxter Healthcare Corporation | |
| GLASSIA | Kamada Ltd. | |
| Prolastin | Talecris Biotherapeutics, Inc. | |
| Prolastin-C | Talecris Biotherapeutics, Inc. | |
| Zemaira | Aventis Behring L.L.C. | |
| Anthrax Vaccine Adsorbed | Biothrax | Emergent BioDefense Operations Lansing, Inc |
| Anti-B (Murine Monoclonal) | None [Anti-B (Murine Monoclonal)] | Immucor, Inc |
| Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) | Genetic Systems HBsAg EIA 3.0 | Bio-Rad Laboratories |
| Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme Immuno Assay (EIA)/Monoclonal) | Auszyme Monoclonal | Abbott Laboratories |
| Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) | ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory | Abbott Laboratories |
| Antihemophilic Factor (Recombinant) | Kogenate FS | Bayer Corp |
| ReFacto | Genetics Institute, Inc | |
| Recombinate | Baxter Healthcare Corporation | |
| Antihemophilic Factor (Recombinant), Plasma/Albumin Free | XYNTHA | Wyeth Pharmaceuticals, Inc |
| Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | Advate | Baxter Healthcare Corp |
| Antihemophilic Factor/von Willebrand Factor Complex (Human) |
| CSL Behring GmbH Grifols Biologicals, Inc |
| Anti-Human Globulin | Anti-Human Globulin Solidscreen II | Biotest AG |
| Anti-Inhibitor Coagulant Complex | FEIBA | Baxter Healthcare Corp |
| Antithrombin (Recombinant) | ATryn | GTC Biotherapeutics, Inc |
| Anti-thymocyte Globulin (Rabbit) | Thymoglobulin | Genzyme Corp |
| Autologous Cellular Immunotherapy | PROVENGE® | Dendreon Corporation |
| Autologous Cultured Chondrocytes | Carticel | Genzyme Biosurgery |
| Azficel-T | LAVIV | Fibrocell Technologies, Inc. |
| (Return to A - Z List) | ||
| B | ||
| Product | Trade Name | Manufacturer |
| BCG Live | TICE BCG | Organon Teknika Corp |
| BCG Vaccine | Organon Teknika Corp | |
| TheraCys | Sanofi Pasteur Limited Lic#1726 | |
| Blood Grouping Reagents | ALBAclone | Alba Bioscience, Inc |
| Blood Grouping Reagent | Component of Erytype S | Biotest Medical Diagnostics GmbH |
| Blood Grouping Reagent | Erytype S | Biotest Medical Diagnostics GmbH |
| Blood Grouping Reagents (ALBAsera) | Anti-Fya ALBAsera® | Alba Bioscience Limited |
| Anti-Fyb ALBAsera® | Alba Bioscience Limited | |
| Anti-Wra ALBAsera® | Alba Bioscience Limited | |
| Anti-s ALBAsera® | Alba Bioscience Limited | |
| Anti-K ALBAsera® | Alba Bioscience Limited | |
| Blood Grouping Reagant Anti-Fya (Monoclonal) | Seraclone | Biotest Medical Diagnostics GmbH |
| Blood Grouping Reagent Anti-s (Monoclonal) | Seraclone | Biotest Medical Diagnostics GmbH |
| Blood Grouping Reagent Anti-S (Monoclonal) | Seraclone | Biotest Medical Diagnostics GmbH |
| Blood Grouping Reagents and Anti-Human Globulin Reagents | Seraclone | Biotest Medical Diagnostics GmbH |
| Blood Grouping Reagent Combination Kit | None [Blood Grouping Reagent Combination Kit] | Micro Typing Systems, Inc |
| Botulism Immune Globulin Intravenous (Human) | BabyBIG | California Department of Health Services |
| (Return to A - Z List) | ||
| C | ||
| Product | Trade Name | Manufacturer |
| C1 Esterase Inhibitor (Human) | Berinert | CSL Behring GmbH |
| Cinryze | Lev Pharmaceuticals, Inc | |
| Coagulation Factor VIIa (Recombinant) | NovoSeven | NovoNordisk, Inc |
| NovoSevenRT | NovoNordisk, Inc | |
| Coagulation Factor IX (Recombinant) | Benefix | Wyeth Pharmaceuticals |
| (Return to A - Z List) | ||
| D | ||
| Product | Trade Name | Manufacturer |
| Diphtheria and Tetanus Toxoids Adsorbed | None [Diphtheria and Tetanus Toxoids Adsorbed] | Sanofi Pasteur, Inc |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed | DAPTACEL | Sanofi Pasteur, Ltd |
| Infanrix | GlaxoSmithKline Biologicals | |
| Tripedia | Sanofi Pasteur, Inc | |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined | Pediarix | GlaxoSmithKline Biologicals |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | KINRIX | GlaxoSmithKline Biologicals |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine | Pentacel | Sanofi Pasteur, Ltd |
| (Return to A - Z List) | ||
| F | ||
| Product | Trade Name | Manufacturer |
| Factor IX Complex | Profilnine® SD | Grifols Biologicals Inc. |
| Factor XIII Concentrate (Human) | Corifact | CSL Behring. GmbH |
| Fibrin Sealants Topical | TISSEEL | Baxter Healthcare Corp |
| ARTISS | Baxter Healthcare Corp | |
| Evicel | Omrix Biopharmaceuticals, Ltd | |
| Fibrin Sealant Patch, Absorbable | EVARREST | Ethicon, Inc |
| TachoSil | Nycomed Danmark ApS | |
| Fibrinogen Concentrate (Human) | RiaSTAP | RiaSTAP (CSL Behring GmbH) |
| (Return to A - Z List) | ||
| H | ||
| Product | Trade Name | Manufacturer |
| Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine | COMVAX | Merck & Co, Inc |
| Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) | PedvaxHIB | Merck Sharp & Dohme Corp. |
| Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | Hiberix | GlaxoSmithKline Biologicals, S.A. |
| ActHIB | Sanofi Pasteur, SA | |
| Hematopoietic Progenitor Cell, Cord Blood | Ducord | Duke University School of Medicine, Carolinas |
| Hematopoietic Progenitor Cells, Cord Blood | Hemacord | New York Blood Center, Inc |
| Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine | TWINRIX | GlaxoSmithKline Biologicals |
| Hepatitis A Vaccine, Inactivated | Havrix | GlaxoSmithKline Biologicals |
| VAQTA | Merck Co, Inc | |
| Hepatitis B Immune Globulin (Human) | Nabi-HB | Nabi Biopharmaceuticals |
| Hepatitis B Immune Globulin Intravenous (Human) | HepaGam B | Cangene Corp |
| Hepatitis B Vaccine (Recombinant) | Recombivax HB | Merck Co, Inc |
| ENGERIX-B | GlaxoSmithKline Biologicals | |
| Hepatitis B Virus Core Antigen (E.coli, Recombinant) | ABBOTT PRISM HBcore | Abbott Laboratories |
| Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) | COBAS AmpliScreen HBV Test | Roche Molecular Systems, Inc |
| Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) | COBAS AmpliScreen HCV Test, version 2.0 | Roche Molecular Systems, Inc |
| Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant) | ABBOTT HCV EIA 2.0 | Abbott Laboratories |
| Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA), Version 3.0/Recombinant and Synthetic) | Ortho HCV Version 3.0 ELISA Test System | Ortho-Clinical Diagnostics, Inc. |
| Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) | ABBOTT PRISM HCV | Abbott Laboratories |
| Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic) (RIBA) | CHIRON RIBA HCV 3.0 Strip Immunoblot Assay | Novartis Vaccines and Diagnostics, Inc |
| Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay | UltraQual HCV-RT-PCR-Assay | National Genetics Institute |
| Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay | None [Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay] | BioLife Plasma Services, LP |
| HPC, Cord Blood | None [HPC, Cord Blood] | Clinimmune Labs, University of Colorado Cord Blood Bank |
| Human Immunodeficiency Virus Type I | Genetic Systems rLAV EIA | Bio-Rad Laboratories |
| Human Immunodeficiency Virus Type 1 (HIV-1) | HIV-1 (Western Blot) | Maxim Biomedical, Inc |
| Avioq HIV-1 Microelisa System | Avioq, Inc. | |
| Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic) | APTIMA HIV-1 RNA Qualitative Assay | Gen-Probe, Inc |
| Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay | COBAS TaqScreen MPX Test | Roche Molecular Systems, Inc. |
| Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic) | Procleix Ultrio Assay | Gen-Probe, Inc |
| Procleix Ultrio Plus Assays | Gen-Probe, Inc | |
| Human Immunodeficiency Virus Type 1 and / or Hepatitis C Virus (HIV-1 and Hepatitis C Virus / Nucleic Acid Pooled Testing / Synthetic) | Procleix HIV-1/HCV Assay | Gen-Probe, Inc |
| Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay | None [Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay] | BioLife Plasma Services, L.P. |
| Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide (ChLIA) | ABBOTT PRISM HIV O Plus | Abbott Park, IL |
| Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA) / Recombinant) | HIVAB HIV-1/HIV-2 (rDNA) EIA | Abbott Laboratories |
| Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2/Enzyme Immunoassay (EIA)/Recombinant and Synthetic) | Genetic Systems HIV-1/HIV-2 Plus O EIA | Bio-Rad Laboratories |
| Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay | UltraQual HIV-1 RT-PCR Assay | National Genetics Institute |
| Human Papillomavirus (HPV)(Types 6, 11, 16, 18) Recombinant Vaccine | GARDASIL | Merck & Co, Inc |
| Human Papillomavirus (HPV) (Types 16 and 18) | Cervarix | GlaxoSmithKline Biologicals, UK |
| Human T-Lymphotropic Virus Types I & II Enzyme Immuno Assay (EIA)/Lysate | Avioq HTLV - I/II Microelisa System | Avioq, Inc. |
| Human T-Lymphotropic Virus Types I & II | Abbott HTLV-I/HTLV-II EIA | Abbott Laboratories |
| ABBOTT PRISM HTLV-I/HTLV-II | Abbott Laboratories | |
| (Return to A - Z List) | ||
| I | ||
| Product | Trade Name | Manufacturer |
| Immune Globulin Intravenous (Human) | Carimune® NF, Nanofiltered | CSL Behring AG |
| Flebogamma | Instituto Grifols, SA | |
| Gammaplex | Bio Products Laboratory | |
| Immune Globulin Intravenous (Human) 5% | OCTAGAM | OCTAPHARMA Pharmazeutika Produktionsges.m.b.H. |
| Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified | Gamunex-C | Talecris Biotherapies, Inc |
| Immune Globulin Intravenous (Human), 10% Liquid | Bivigam | Biotest Pharmaceuticals Corporation |
| Privigen | CSL Behring AG | |
| Immune Globulin Intravenous (Human), 10% Solution | Gammagard Liquid | Baxter Healthcare Corp |
| Immune Globulin Subcutaneous (Human) | Hizentra | CSL Behring AG |
| Vivaglobin | CSL Behring GmbH | |
| Immune Globulin Products (Animal-derived) | CroFab | Protherics, Inc |
| Anascorp | Rare Disease Therapeutics, Inc. | |
| DigiFab | Protherics Inc | |
| Influenza A (H1N1) 2009 Monovalent Vaccine | None [Influenza A (H1N1) 2009 Monovalent Vaccine] | CSL Limited ID Biomedical Corporation of Quebec MedImmune LLC Novartis Vaccines and Diagnostics Limited Sanofi Pasteur, Inc. |
| Influenza Vaccine | Flublok | Protein Sciences Corporation |
| Influenza Virus Vaccine | Afluria | CSL Limited |
| Agriflu | Novartis Vaccines and Diagnostics, Inc. | |
| Fluarix | GlaxoSmithKline Biologicals | |
| Fluarix Quadrivalent | GlaxoSmithKline Biologicals | |
| Flucelvax | Novartis Vaccines and Diagnostics, Inc. | |
| FluLaval | ID Biomedical Corporation of Quebec | |
| Fluvirin | Novartis Vaccines and Diagnostics Limited | |
| Fluzone, Fluzone High-Dose and Fluzone Intradermal | Sanofi Pasteur, Inc | |
| Influenza Virus Vaccine, H5N1 | None [Influenza Virus Vaccine, H5N1] | Sanofi Pasteur, Inc |
| Influenza Virus Vaccine, Live, Intranasal | FluMist | MedImmune Vaccines, Inc |
| FluMist® Quadrivalent | MedImmune LLC | |
| (Return to A - Z List) | ||
| J | ||
| Product | Trade Name | Manufacturer |
| Japanese Encephalitis Virus Vaccine Inactivated | JE-Vax | Research Foundation for Microbial Diseases of Osaka University |
| Japanese Encephalitis Vaccine, Inactivated, Adsorbed | IXIARO | Intercell Biomedical |
| (Return to A - Z List) | ||
| M | ||
| Product | Trade Name | Manufacturer |
| Measles, Mumps and Rubella Virus Vaccine, Live | M-M-R II | Merck & Co, Inc |
| Measles, Mumps, Rubella and Varicella Virus Vaccine Live | ProQuad | Merck & Co, Inc |
| Measles Virus Vaccine Live | ATTENUVAX | Merck & Co, Inc |
| Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | Menveo | Novartis Vaccines and Diagnostics, Inc. |
| Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Menactra | Sanofi Pasteur, Inc |
| Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine | MenHibrix | GlaxoSmithKline Biologicals |
| Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined | Menomune-A/C/Y/W-135 | Sanofi Pasteur, Inc |
| (Return to A - Z List) | ||
| O | ||
| Product | Trade Name | Manufacturer |
| OLYMPUS PK System Blood Grouping and Phenotyping Reagents | None [OLYMPUS PK System Blood Grouping and Phenotyping Reagents] | DIAGAST |
| (Return to A - Z List) | ||
| P | ||
| Product | Trade Name | Manufacturer |
| Pneumococcal Vaccine, Polyvalent | Pneumovax 23 | Merck & Co, Inc |
| Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) | Prevnar | Wyeth Pharmaceuticals, Inc |
| Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) | Prevnar 13 | Wyeth Pharmaceuticals, Inc |
| Poliovirus Vaccine Inactivated (Monkey Kidney Cell) | IPOL | Sanofi Pasteur, SA |
| Pooled Plasma (Human), Solvent/Detergent Treated | Octaplas | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| Protein C Concentrate (Human) | CEPROTIN | Baxter Healthcare Corp |
| (Return to A - Z List) | ||
| R | ||
| Product | Trade Name | Manufacturer |
| Rabies Vaccine | IMOVAX | Sanofi Pasteur, SA |
| Rabies Vaccine | RabAvert | Novartis Vaccines and Diagnostics |
| Reagent Red Blood Cells | ALBAcyte | Alba Bioscience Limited |
| None [Reagent Red Blood Cells] | Medion Diagnostics AG | |
| Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated Systems | Biotestcell and Erytypecell | Biotest Medical Diagnostics GmbH |
| Rho(D) Immune Globulin Intravenous (Human) | Rhophylac | CSL Behring AG |
| WinRho SDF Liquid | Cangene Corp | |
| Rotavirus Vaccine, Live, Oral | ROTARIX | GlaxoSmithKline Biologicals |
| Rotavirus Vaccine, Live, Oral, Pentavalent | RotaTeq | Merck & Co, Inc |
| Rubella Virus Vaccine Live | MERUVAX II | Merck & Co, Inc |
| (Return to A - Z List) | ||
| S | ||
| Product | Trade Name | Manufacturer |
| Smallpox (Vaccinia) Vaccine, Live | ACAM2000 | Sanofi Pasteur Biologics Co. |
| Coccidioides immitis Spherule - Derived Skin Test Antigen | Spherusol | Allermed Laboratories, Inc. |
| (Return to A - Z List) | ||
| T | ||
| Product | Trade Name | Manufacturer |
| Tetanus and Diphtheria Toxoids Adsorbed for Adult Use |
| Sanofi Pasteur, Inc
Sanofi Pasteur, Ltd |
| Tetanus Toxoid Adsorbed | None [Tetanus Toxoid Adsorbed] | Sanofi Pasteur, Inc |
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | Adacel | Sanofi Pasteur, Ltd |
| Boostrix | GlaxoSmithKline Biologicals | |
| Thin-Layer Rapid Use Epicutaneous Patch Test | T.R.U.E. TEST | Mekos Laboratories AS |
| Thrombin, Topical (Human) | Evithrom | OMRIX Biopharmaceuticals, Ltd |
| Thrombin, Topical (Recombinant) | RECOTHROM | ZymoGenetics, Inc |
| Thrombin, Topical (Bovine Origin) | THROMBIN-JMI | Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Manufactured by: GenTrac, Incorporated, Middleton, Wisconsin 53562 |
| Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay) | Abbott Laboratories | |
| Trypanosoma cruzi (T.cruzi) Whole Cell Lysate Antigen | ORTHO T.cruzi ELISA Test System | Ortho-Clinical Diagnostics, Inc |
| Trypanosoma Cruzi (T. cruzi) (E. Coli, Recombinant) | ABBOTT ESA Chagas | Abbott Laboratories |
| Tuberculin, Purified Protein Derivative | Aplisol | JHP Pharmaceuticals, LLC |
| Tubersol | Sanofi Pasteur, Ltd | |
| Typhoid Vaccine Live Oral Ty21a | Vivotif | Berna Biotech, Ltd |
| Typhoid Vi Polysaccharide Vaccine | Typhim Vi | Sanofi Pasteur, SA |
| (Return to A - Z List) | ||
| V | ||
| Product | Trade Name | Manufacturer |
| Vaccinia Immune Globulin Intravenous (Human) | None | Cangene Corp. |
| Varicella Virus Vaccine Live | Varivax | Merck & Co, Inc |
| Varicella Zoster Immune Globulin (Human) | VARIZIG | Cangene Corporation |
| (Return to A - Z List) | ||
| W | ||
| Product | Trade Name | Manufacturer |
| von Willebrand Factor/Coagulation Factor VIII Complex (Human) | Wilate® | Octapharma Pharmazeutika Produktionsges.m.b.H. |
| West Nile Virus (WNV) RNA | cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system | Roche Molecular System, Inc |
| West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) | Procleix West Nile Virus (WNV) Assay | Gen-Probe, Inc |
| (Return to A - Z List) | ||
| Y | ||
| Product | Trade Name | Manufacturer |
| Yellow Fever Vaccine | YF-Vax | Sanofi Pasteur, Inc |
| (Return to A - Z List) | ||
| Z | ||
| Product | Trade Name | Manufacturer |
| Zoster Vaccine | Zostavax | Merck & Co, Inc |
| (Return to A - Z List) | ||
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