EMA/PE/0000183137 - paediatric investigation plan

encaleret

Key facts

• Active substance:
  encaleret
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  EMA/PE/0000183137
• PIP number:
  EMA/PE/0000183137
• Pharmaceutical form(s):
  • Age appropriate oral dosage formulation
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of hypoparathyroidism
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000183137 : EMA decision of 6 December 2025 on the acceptance of a modification of an agreed paediatric investigation plan for encaleret

Adopted Reference Number: EMADOC-1700519818-1759915