P/22/2011 - paediatric investigation plan

Grass pollen allergen extract from Dactylis glomerata L., Anthoxanthum odoratum L., Lolium perenne L., Poa prantensis L. and Phleum pratense L.

Key facts

• Active Substance:
  Grass pollen allergen extract from Dactylis glomerata L., Anthoxanthum odoratum L., Lolium perenne L., Poa prantensis L. and Phleum pratense L.
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/22/2011
• PIP number:
  P/22/2011
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• Route(s) of administration:
  Sublingual use
• Contact for public enquiries:

  Stallergenes S.A.

  [e-mail]; France; Phone: [phone]; Fax: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  25/01/2011

Decision

P/22/2011: EMA decision of 25 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for grass pollen allergen extract from Dactylis glomerata ...

AdoptedReference Number: EMA/25657/2011