INFANRIX - Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
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Field |
Value |
NDC Code: |
58160-810 |
Proprietary Name: |
INFANRIX |
Suffix: |
|
Non-Proprietary Name: |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Dosage Form: |
SUSPENSION |
Method: |
INTRAMUSCULAR |
Original Marketing Date: |
24-07-2009 |
Category Name: |
BLA |
Application Number: |
BLA103647 |
Labeler: |
GLAXOSMITHKLINE BIOLOGICALS SA |
Substance Name: |
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) |
Active Numerator Strength: |
25; 8; 25; 10; 25 |
Active Ingredient Unit: |
ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL |
Pharm Classes: |
Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient] |
DEA Schedule: |
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