EMEA-001462-PIP01-13 - paediatric investigation plan

recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (VRS-317)

Key facts

• Active substance:
  recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (VRS-317)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0065/2014
• PIP number:
  EMEA-001462-PIP01-13
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of growth hormone deficiency
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/03/2014
• Compliance check done:
  No

Decision

P/0065/2014: European Medicines Agency decision of 10 March 2014 on the refusal of a paediatric investigation plan and on the granting of a waiver for recombinant human growth hormone modified by fusion with two hydrophi...

Adopted Reference Number: EMA/55121/2014