EMEA-000370-PIP02-18

Key facts

Active substance
Oxalobacter formigenes strain HC-1
Therapeutic area
  • Endocrinology, -gynacology-fertility-metabolism
  • Uro-nephrology
Decision number
P/0273/2019
PIP number
EMEA-000370-PIP02-18
Pharmaceutical form(s)
  • Powder for oral suspension
  • Gastro-resistant tablet
  • Gastro-resistant granules for oral suspension
Condition(s) / indication(s)
Treatment of hyperoxaluria
Route(s) of administration
  • Oral use
  • Gastric use
Contact for public enquiries
OxThera AB
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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