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FDA Product

PREVNAR 13

Product approved by U.S. Food and Drug Administration (US)

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

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

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