EMEA-001545-PIP01-13-M02 - paediatric investigation plan

Live, attenuated, chimeric dengue virus, serotype 1

Live, attenuated, chimeric dengue virus, serotype 2

live, attenuated, chimeric dengue virus, serotype 3

Live, attenuated, chimeric dengue virus, serotype 4

Key facts

• Invented name:
  Dengvaxia
• Active Substance:
  • Live, attenuated, chimeric dengue virus, serotype 1
  • Live, attenuated, chimeric dengue virus, serotype 2
  • live, attenuated, chimeric dengue virus, serotype 3
  • Live, attenuated, chimeric dengue virus, serotype 4
• Therapeutic area:
  Vaccines
• Decision number:
  P/0065/2020
• PIP number:
  EMEA-001545-PIP01-13-M02
• Pharmaceutical form(s):
  Powder and solvent for suspension for injection
• Condition(s) / indication(s):
  Prevention of dengue fever
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Sanofi Pasteur

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/02/2020
• Compliance procedure number:
  EMEA-C-001545-PIP01-13-M02
• Compliance opinion date:
  29/05/2020
• Compliance outcome:
  Positive

Decision

P/0065/2020: EMA decision of 21 February 2020 on the acceptance of a modification of an agreed PIP for live, attenuated, chimeric dengue virus, serotype 1 / live, attenuated, chimeric dengue virus, serotype 2 / live, attenuated, chimeric dengue virus...

AdoptedReference Number: EMA/85734/2020