EMEA-000856-PIP01-10 - paediatric investigation plan

Pollen from Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis and Anthoxhantum odoratum (20% each)

Key facts

• Active substance:
  Pollen from Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis and Anthoxhantum odoratum (20% each)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/299/2010
• PIP number:
  EMEA-000856-PIP01-10
• Pharmaceutical form(s):
  Oralmucosal drops
• Condition(s) / indication(s):
  • Treatment of rhino-conjuctivitis
  • Treatment of allergic rhinitis
• Route(s) of administration:
  Sublingual use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/12/2010
• Compliance check done:
  No

Decision

P/299/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Pollen from Dactylis glomarata, Lolium perenne, Phle...

Adopted Reference Number: EMA/778321/2010