EMEA-000850-PIP01-10 - paediatric investigation plan

Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis, Secale cereale, Betula verrucosa, Corylus avellana and Alnus glutinosa

Key facts

• Invented name:
  EMEA-000850-PIP01-10
• Active Substance:
  Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis, Secale cereale, Betula verrucosa, Corylus avellana and Alnus glutinosa
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/297/2010
• PIP number:
  EMEA-000850-PIP01-10
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  • Treatment of rhino-conjuctivitis
  • Treatment of allergic rhinitis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  ALK-Abelló A/S

  [e-mail]; [e-mail]; Denmark; 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:
  22/12/2010

Decision

P/297/2010: 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 glomerata, festuca pratensis, l...

AdoptedReference Number: EMA/683411/2010