EMEA-002514-PIP01-18 - paediatric investigation plan

Mometasone (furoate monohydrate)

Olopatadine (hydrochloride) (GSP 301 NS)

Key facts

• Active Substance:
  • Mometasone (furoate monohydrate)
  • Olopatadine (hydrochloride) (GSP 301 NS)
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0170/2019
• PIP number:
  EMEA-002514-PIP01-18
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• Route(s) of administration:
  Intranasal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/05/2019
• Compliance procedure number:
  EMEA-C-002514-PIP01-18
• Compliance opinion date:
  27/03/2020
• Compliance outcome:
  Positive

Decision

P/0170/2019: EMA decision of 15 May 2019 on the agreement of a paediatric investigation plan and on the granting of a waiver for mometasone (furoate monohydrate) / olopatadine (hydrochloride) (gsp 301 ns) (EMEA-002514-PIP01-18)

AdoptedReference Number: EMA/227151/2019