EMEA-002393-PIP01-18 - paediatric investigation plan

cell-free solution of lysed Escherichia coli culture, strain Laves

Key facts

• Active substance:
  cell-free solution of lysed Escherichia coli culture, strain Laves
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0328/2018
• PIP number:
  EMEA-002393-PIP01-18
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  • Treatment of irritable bowel syndrome (IBS)
  • Treatment of ulcerative colitis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/10/2018
• Compliance check done:
  No

Decision

P/0328/2018: EMA decision of 8 October 2018 on the granting of a product specific waiver for cell-free solution of lysed Escherichia coli culture, strain Laves (Colibiogen oral / Synerga / Colibiogen mild), (EMEA-002393-PIP01-18)

Reference Number: EMA/646811/2018