EMEA-002984-PIP01-21 - paediatric investigation plan

terbinafine hydrochloride

Key facts

• Active substance:
  terbinafine hydrochloride
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0450/2021
• PIP number:
  EMEA-002984-PIP01-21
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Treatment of onychomycosis
• Route(s) of administration:
  Topical use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0450/2021 : EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for terbinafine (hydrochloride) (EMEA-002984-PIP01-21)

Adopted Reference Number: EMA/535477/2021