EMEA-002739-PIP01-19 - paediatric investigation plan

hydrocortisone

benzocaine

Key facts

• Active substance:
  • hydrocortisone
  • benzocaine
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0181/2020
• PIP number:
  EMEA-002739-PIP01-19
• Pharmaceutical form(s):
  Rectal ointment
• Condition(s) / indication(s):
  Treatment of haemorrhoidal disease
• Route(s) of administration:
  Rectal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2020
• Compliance check done:
  No

Decision

P/0181/2020: EMA decision of 13 May 2020 on the granting of a product specific waiver for hydrocortisone acetate / benzocaine (EMEA-002739-PIP01-19)

Reference Number: EMA/233389/2020