EMEA-001982-PIP01-16 - paediatric investigation plan

gentamicin sulfate

Key facts

• Active substance:
  gentamicin sulfate
• Therapeutic area:
  Dermatology
• Decision number:
  P/0271/2016
• PIP number:
  EMEA-001982-PIP01-16
• Pharmaceutical form(s):
  Medicated sponge
• Condition(s) / indication(s):
  Treatment of infected diabetic foot ulcers
• Route(s) of administration:
  Topical use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/10/2016
• Compliance check done:
  No

Decision

P/0271/2016: EMA decision of 7 October 2016 on the granting of a product specific waiver for gentamicin (sulphate) (EMEA-001982-PIP01-16)

Adopted Reference Number: EMA/633120/2016