EMEA-000036-PIP01-07-M06

Key facts

Invented name
Prevenar 13
Active substance
13-valent pneumococcal polysaccharide conjugate vaccine: pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F; diphtheria CRM197 conjugate
Therapeutic area
Vaccines
Decision number
P/0161/2012
PIP number
EMEA-000036-PIP01-07-M06
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Disease caused by Streptococcus pneumoniae
Route(s) of administration
Intramuscular use
Contact for public enquiries
Pfizer Ltd

E-mail: pip_enquiries@pfizer.com
Tel. +44 (0)1304 646607

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000036-PIP01-07-M06
Compliance opinion date
10/10/2014
Compliance outcome
positive

Decision

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