EMA/PE/0000253047 - paediatric investigation plan

encaleret

Key facts

• Active substance:
  encaleret
• Therapeutic area:
  • Endocrine disorders
  • Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  EMA/PE/0000253047
• PIP number:
  EMA/PE/0000253047
• 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:
  10/07/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000253047 : EMA decision of 10 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for encaleret

Adopted Reference Number: EMADOC-1700519818-2252167