EMEA-000806-PIP01-09 - paediatric investigation plan

12 Grass Pollen Extract and Cultivated Rye Pollen Extract

Key facts

• Active substance:
  12 Grass Pollen Extract and Cultivated Rye Pollen Extract
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/216/2010
• PIP number:
  EMEA-000806-PIP01-09
• Pharmaceutical form(s):
  Oromucosal solution
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• 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:
  29/10/2010
• Compliance check done:
  Non

Decision

P/216/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 12 Grass Pollen Extract and Cult...

Adopted Reference Number: EMA/615516/2010