EMEA-002258-PIP01-17 - paediatric investigation plan

recombinant human epidermal growth factor

Key facts

• Active substance:
  recombinant human epidermal growth factor
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0038/2018
• PIP number:
  EMEA-002258-PIP01-17
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of diabetic foot ulcer
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2018
• Compliance check done:
  No

Decision

P/0038/2018: EMA decision of 30 January 2018 on the granting of a product specific waiver for recombinant human epidermal growth factor (EMEA- 002258-PIP01-17)

Reference Number: EMA/848796/2017