EMEA-001545-PIP01-13-M02

Table of contents

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: contact-us@sanofi.com
Tel. +33 1 6974 5695

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

Decision

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