EMEA-002232-PIP02-19-M02 - paediatric investigation plan

Bis-choline tetrathiomolybdate

Key facts

• Active Substance:
  Bis-choline tetrathiomolybdate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0164/2022
• PIP number:
  EMEA-002232-PIP02-19-M02
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Coated tablet
• Condition(s) / indication(s):
  Treatment of Wilson Disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022

Decision

P/0164/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bis-choline tetrathiomolybdate (EMEA-002232-PIP02-19-M02)

AdoptedReference Number: EMA/207916/2022