EMEA-001113-PIP01-10-M06 - paediatric investigation plan

Delamanid

Key facts

• Invented name:
  • Deltyba
  • Deltyba
• Active substance:
  Delamanid
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0271/2019
• PIP number:
  EMEA-001113-PIP01-10-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  Treatment of multi-drug-resistant tuberculosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2019
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001113-PIP01-10-M06
• Compliance opinion date:
  24/07/2020
• Compliance outcome:
  Positive

Decision

P/0271/2019: EMA decision of 14 August 2019 on the acceptance of a modification of an agreed paediatric investigation plan for delamanid (Deltyba), (EMEA-001113-PIP01-10-M06)

Adopted Reference Number: EMA/392697/2019