EMEA-001152-PIP02-16 - paediatric investigation plan

Recombinant modified human growth hormone

Key facts

• Active Substance:
  Recombinant modified human growth hormone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0121/2017
• PIP number:
  EMEA-001152-PIP02-16
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of growth hormone deficiency
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  05/05/2017

Decision

P/0121/2017: EMA decision of 5 May 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for recombinant modified human growth hormone (EMEA-001152-PIP02...

AdoptedReference Number: EMA/250886/2017