MHRA-101980-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Group B Streptococcus 6-valent polysaccharide conjugate vaccine (GBS6)
Invented Name
Not available at present
PIP Number MHRA-101980-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of Group B Streptococcus invasive disease via maternal immunisation.
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Group B Streptococcus 6-valent polysaccharide conjugate vaccine (GBS6).pdf
Published Date 18/09/2026