EMEA-000347-PIP05-20 - paediatric investigation plan

bilastine

Key facts

• Invented name:
  Bilaxten and associated names
• Active substance:
  bilastine
• Therapeutic area:
  • Dermatology
  • Oto-rhino-laryngology
  • Pneumology-allergology
• Decision number:
  P/0219/2020
• PIP number:
  EMEA-000347-PIP05-20
• Pharmaceutical form(s):
  • Oral solution
  • Orodispersible tablet
  • Solution for injection
  • Tablet
• Condition(s) / indication(s):
  Treatment of acute type I hypersensitivity reactions
• Route(s) of administration:
  • Oral use
  • Intramuscular use
  • Intravenous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  17/06/2020
• Compliance check done:
  No

Decision

P/0219/2020: EMA decision of 17 June 2020 on the refusal of a product specific waiver for bilastine (Bilaxten and associated names), (EMEA- 000347-PIP05-20)

Adopted Reference Number: EMA/304407/2020