Basic Information
PREVNAR 13
50090-1944
Regulatory Information
50090-1944
BLA125324
C73585
August 29, 2017
USA
These highlights do not include all the information needed to use PREVNAR 13 safely and effectively. See full prescribing information for PREVNAR 13. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM Protein]) Suspension for intramuscular injection Initial U.S. Approval: 2010
VACCINE LABEL
11
Company Information
830016429
Active Ingredients
ALUMINUM PHOSPHATE
Quantity: 125 ug in 0.5 mL
Code: F92V3S521O
Class Code: IACT
Quantity: 2.2 ug in 0.5 mL
Code: 54EC0SE5PZ
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: 2VF3V7175U
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: TGJ6YZC4W7
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: 5SKG37872O
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: Z9HK08690W
Class Code: ACTIB
Quantity: 4.4 ug in 0.5 mL
Code: 4M543JVT7G
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: 0K0S2P98ZJ
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: 5Q768OY0GI
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: SK54I0S386
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: XK87D9J012
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: 25N8E57V6T
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: B970MQT365
Class Code: ACTIB
Quantity: 2.2 ug in 0.5 mL
Code: 2E1M7F958B
Class Code: ACTIB
POLYSORBATE 80
Quantity: 100 ug in 0.5 mL
Code: 6OZP39ZG8H
Class Code: IACT
Active Moieties
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: 54EC0SE5PZ
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: 2VF3V7175U
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: TGJ6YZC4W7
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: 5SKG37872O
STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: Z9HK08690W
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: 4M543JVT7G
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: 0K0S2P98ZJ
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: 5Q768OY0GI
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: SK54I0S386
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: XK87D9J012
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: 25N8E57V6T
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: 2E1M7F958B
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Code: B970MQT365