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CAPVAXIVE (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
CAPVAXIVE
Date registered
Evaluation commenced
Decision date
Approval time
226 (255 working days)
Active ingredients
Pneumococcal purified capsular polysaccharides
Registration type
NCE/ NBE
Indication
CAPVAXIVE is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults 18 years of age and older.
CAPVAXIVE may not prevent disease cause by S. pneumoniae serotypes that are not listed in the indications.
The use of CAPVAXIVE should be guided by official recommendations.