EMEA-000816-PIP01-09 - paediatric investigation plan

sodium sulfate

potassium sulfate

magnesium sulfate heptahydrate

Key facts

• Active substance:
  • sodium sulfate
  • potassium sulfate
  • magnesium sulfate heptahydrate
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/116/2010
• PIP number:
  EMEA-000816-PIP01-09
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Diseases of the intestines
• Route(s) of administration:
  Oral use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  07/07/2010
• Compliance check done:
  No

Decision

P/116/2010: European Medicines Agency decision of 7 July 2010 on the refusal of a product specific waiver for sodium sulfate/potassium sulfate/magnesium sulfate heptahydrate (EMEA-000816-PIP01-09) in accordance with Regu...

Adopted Reference Number: EMA/343627/2010