EMEA-002143-PIP01-17 - paediatric investigation plan

benzydamine (hydrochloride)

econazole nitrate

Key facts

• Active substance:
  • benzydamine (hydrochloride)
  • econazole nitrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0184/2017
• PIP number:
  EMEA-002143-PIP01-17
• Pharmaceutical form(s):
  Pessary
• Condition(s) / indication(s):
  Treatment of vulvovaginal candidiasis
• Route(s) of administration:
  Vaginal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/06/2017
• Compliance check done:
  No

Decision

P/0184/2017: EMA decision of 30 June 2017 on the granting of a product-specific waiver for econazole (nitrate) / benzydamine (hydrochloride) (EMEA-002143-PIP01-17)

Adopted Reference Number: EMA/371181/2017