EMEA-002646-PIP01-19 - paediatric investigation plan

levocetirizine

montelukast

Key facts

• Active substance:
  • levocetirizine
  • montelukast
• Therapeutic area:
  • Oto-rhino-laryngology
  • Pneumology-allergology
• Decision number:
  P/0056/2020
• PIP number:
  EMEA-002646-PIP01-19
• Pharmaceutical form(s):
  • Tablet
  • Powder for oral solution
• Condition(s) / indication(s):
  Treatment of allergic rhinitis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/02/2020
• Compliance check done:
  No

Decision

P/0056/2020: EMA decision of 10 February 2020 on the granting of a product specific waiver for levocetirizine / montelukast (EMEA-002646-PIP01-19)

Adopted Reference Number: EMA/28566/2020