Live bacterium B. thetaiotaomicron - paediatric investigation plan

Live bacterium B. thetaiotaomicron

Key facts

• Active Substance:
  Live bacterium B. thetaiotaomicron
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/166/2009
• PIP number:
  Live bacterium B. thetaiotaomicron
• Pharmaceutical form(s):
  Live Bacteria in an Enteric Coated Capsule
• Condition(s) / indication(s):
  Treatment of Crohn's disease
• Route(s) of administration:
  Oral use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  21/08/2009

Decision

P/166/2009: European Medicines Agency decision of 21 August 2009 on the refusal of a Paediatric Investigation Plan for live bacterium B. thetaiotaomicron (EMEA-000561-PIP01-09) in accordance with Regulation (EC) No 1901/...

AdoptedReference Number: EMEA/494847/2009