P/149/2011 - paediatric investigation plan

rotavirus serotype G1

rotavirus serotype G2

rotavirus serotype G3

rotavirus serotype G4

rotavirus serotype P1A[8]

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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/06/2011
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000967-PIP01-10-M01
• Compliance opinion date:
  21/07/2011
• Compliance outcome:
  Positive

Decision

P/149/2011: EMA decision of 9 June 2011 on the acceptance of a modification of an agreed paediatric investigation plan for rotavirus type G1/rotavirus type G2/rotavirus type G3/rotavirus type G4/rotavirus type P1A[8] (Ro...

Adopted Reference Number: EMA/387137/2011