EMEA-003122-PIP01-21-M01 - paediatric investigation plan

Azelastine (hydrochloride)

Mometasone furoate

Key facts

• Active Substance:
  • Azelastine (hydrochloride)
  • Mometasone furoate
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0020/2023
• PIP number:
  EMEA-003122-PIP01-21-M01
• Pharmaceutical form(s):
  Nasal spray suspension
• Condition(s) / indication(s):
  Treatment of allergic rhinitis
• Route(s) of administration:
  Nasal use
• Contact for public enquiries:

  Lek Pharmaceuticals d.d.; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2023

Decision

P/0020/2023: EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for mometasone (furoate) / azelastine (hydrochloride) (EMEA-003122-PIP01-21-M01)

Reference Number: EMA/19486/2023