EMEA-001156-PIP01-11-M07 - paediatric investigation plan

recombinant dimer of 6 kD early secretory antigenic target

recombinant 10 kD culture filtrate protein

Key facts

• Active substance:
  • recombinant dimer of 6 kD early secretory antigenic target
  • recombinant 10 kD culture filtrate protein
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0188/2016
• PIP number:
  EMEA-001156-PIP01-11-M07
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnosis of tuberculosis
• Route(s) of administration:
  Intradermal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/07/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001156-PIP01-11-M07
• Compliance opinion date:
  11/11/2022
• Compliance outcome:
  Positive

Decision

P/0188/2016: EMA decision of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant dimer of 6 kD early secretory antigenic target / recombinant 10 kD culture filtrate...

Adopted Reference Number: EMA/399717/2016