EMEA-002955-PIP01-21 - paediatric investigation plan

Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1) (TransCon PTH)

Key facts

• Active Substance:
  Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1) (TransCon PTH)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0021/2022
• PIP number:
  EMEA-002955-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hypoparathyroidism
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Ascendis Pharma Bone Diseases A/S

  Email: [e-mail]; Tel. [phone];

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2022

Decision

P/0021/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for poly(oxy-1,2- ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1....(EMEA-002955-PIP01-21)

Reference Number: EMA/8320/2022