EMEA-000325-PIP01-08-M11 - paediatric investigation plan

Tapentadol (hydrochloride)

Key facts

• Active Substance:
  Tapentadol (hydrochloride)
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0469/2023
• PIP number:
  EMEA-000325-PIP01-08-M11
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Prolonged-release granules
• Condition(s) / indication(s):
  Treatment of chronic pain
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023

Decision

P/0469/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia, Tapentadol Libra-Pharm, Yantil, and Ationdo), (EMEA-000325-PIP01-08-M11)

AdoptedReference Number: EMA/512496/2023