P/149/2011 - paediatric investigation plan

rotavirus serotype G1
rotavirus serotype G2
rotavirus serotype G3
rotavirus serotype G4
rotavirus serotype P1A[8]
PIP Human

Key facts

Invented name
  • RotaTeq
  • RotaTeq
Active substance
  • rotavirus serotype G1
  • rotavirus serotype G2
  • rotavirus serotype G3
  • rotavirus serotype G4
  • rotavirus serotype P1A[8]
Therapeutic area
Vaccines
Decision number
P/149/2011
PIP number
P/149/2011
Pharmaceutical form(s)
Oral solution
Condition(s) / indication(s)
Prevention of rotaviral enteritis
Route(s) of administration
Oral use
Contact for public enquiries

Sanofi Pasteur MSD SNC

piplan@spmsd.com
France
Phone: +33 437284000

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance check done
Yes
Compliance procedure number
EMEA-C-000967-PIP01-10-M01
Compliance opinion date
Compliance outcome
Positive

Decision

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