EMEA-001259-PIP02-13-M02 - paediatric investigation plan

Terbinafine hydrochloride

Key facts

• Active Substance:
  Terbinafine hydrochloride
• Therapeutic area:
  Dermatology
• Decision number:
  P/0221/2019
• PIP number:
  EMEA-001259-PIP02-13-M02
• Pharmaceutical form(s):
  Medicated nail lacquer
• Condition(s) / indication(s):
  Treatment of onychomycosis
• Route(s) of administration:
  Topical use
• Contact for public enquiries:

  Polichem S.A. (Spain)

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/06/2019
• Compliance procedure number:
  EMEA-C-001259-PIP02-13-M02
• Compliance opinion date:
  26/07/2019
• Compliance outcome:
  Positive

Decision

P/0221/2019: EMA decision of 17 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for terbinafine (hydrochloride) (EMEA-001259-PIP02-13-M02)

AdoptedReference Number: EMA/327869/2019