EMEA-001754-PIP01-15 - paediatric investigation plan

Rifamycin

Key facts

• Active Substance:
  Rifamycin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0180/2015
• PIP number:
  EMEA-001754-PIP01-15
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of acute infectious diarrhoea
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Dr. Falk Pharma GmbH

  Email: [e-mail]; Tel.: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/08/2015

Decision

P/0180/2015: EMA decision of 7 August 2015 on the granting of a product-specific waiver for rifamycin (EMEA-001754-PIP01-15)

AdoptedReference Number: EMA/508333/2015