EMEA-001820-PIP01-15 - paediatric investigation plan

Recombinant human growth hormone fused to hybrid Fc composed of the hinge region and N-terminal of CH2 domain of IgD and C-terminal of CH2 and full CH3 domain of IgG4

Key facts

• Active Substance:
  Recombinant human growth hormone fused to hybrid Fc composed of the hinge region and N-terminal of CH2 domain of IgD and C-terminal of CH2 and full CH3 domain of IgG4
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0291/2015
• PIP number:
  EMEA-001820-PIP01-15
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of growth hormone deficiency
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Genexine, Inc.

  Hungary; Tel. [phone]; Fax [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/11/2015

Decision

P/0291/2015: EMA decision of 27 November 2015 on the refusal of a paediatric investigation plan and on the granting of a waiver for recombinant human growth hormone fused to hybrid Fc composed of the hinge region and N-t...

AdoptedReference Number: EMA/690013/2015