EMEA-001535-PIP01-13-M01 - paediatric investigation plan

potassium citrate monohydrated

potassium hydrogen carbonate (ADV7103)

Key facts

• Active substance:
  • potassium citrate monohydrated
  • potassium hydrogen carbonate (ADV7103)
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0214/2018
• PIP number:
  EMEA-001535-PIP01-13-M01
• Pharmaceutical form(s):
  Prolonged-release granules
• Condition(s) / indication(s):
  Treatment of cystinuria
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/07/2018
• Compliance check done:
  No

Decision

P/0214/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for potassium citrate monohydrated / potassium hydrogen carbonate (ADV7103) (EMEA-001535-PIP01-13-M01)

Adopted Reference Number: EMA/465548/2018