EMEA-000370-PIP02-18-M01 - paediatric investigation plan

Oxalobacter formigenes strain HC-1

Key facts

• Active Substance:
  Oxalobacter formigenes strain HC-1
• Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Uro-nephrology
• Decision number:
  P/0447/2021
• PIP number:
  EMEA-000370-PIP02-18-M01
• Pharmaceutical form(s):
  • Powder for oral suspension
  • Gastro-resistant tablet
  • Gastro-resistant granules for oral suspension
  • Gastro-resistant capsule (hard)
• Condition(s) / indication(s):
  Treatment of hyperoxaluria
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  OxThera AB

  E-mail: [e-mail], [e-mail] ; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/10/2021

Decision

P/0447/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for oxalobacter formigenes strain HC-1 (EMEA-000370-PIP02-18-M01)

AdoptedReference Number: EMA/534531/2021