EMEA-003348-PIP01-22 - paediatric investigation plan

encaleret

Key facts

• Active substance:
  encaleret
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0324/2023
• PIP number:
  EMEA-003348-PIP01-22
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2023
• Compliance check done:
  No

Decision

P/0324/2023 : EMA decision of 11 August 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for encaleret (EMEA-003348-PIP01-22)

Reference Number: EMA/330466/2023