EMEA-002330-PIP01-18-M01

Table of contents

Key facts
Decision

Key facts

Active substance	Pneumococcal Polyssacharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polyssacharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
Therapeutic area	Vaccines
Decision number	P/0380/2021
PIP number	EMEA-002330-PIP01-18-M01
Pharmaceutical form(s)	Suspension for injection
Condition(s) / indication(s)	Prevention of disease caused by Streptococcus pneumoniae
Route(s) of administration	Intramuscular use
Contact for public enquiries	Pfizer Europe MA EEIG E-mail: pip_enquiries@pfizer.com Tel: +44 1304616161
Decision type	PM: decision on the application for modification of an agreed PIP

Decision

List item

EMA/470768/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for Pneumococcal Polyssacharide Serotype 6A conjugated to CRM197 carrier protein.....(EMEA- 002330-PIP01-18-M01) (PDF/258.74 KB)

Adopted

First published: 13/01/2023
EMA/470768/2021

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