EMEA-002155-PIP01-17 - paediatric investigation plan

Non-pathogenic bacterial lysate of Escherichia coli and Enterococcus faecalis

Key facts

• Active Substance:
  Non-pathogenic bacterial lysate of Escherichia coli and Enterococcus faecalis
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0095/2018
• PIP number:
  EMEA-002155-PIP01-17
• Pharmaceutical form(s):
  Age-appropriate oral liquid dosage form
• Condition(s) / indication(s):
  Treatment of irritable bowel syndrome (IBS)
• 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:
  16/03/2018

Decision

P/0095/2018: EMA decision of 16 March 2018 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for non-pathogenic bacterial lysate of Escherichia coli and E...

AdoptedReference Number: EMA/102420/2018