EMEA-000905-PIP01-10 - paediatric investigation plan

Lolium perenne

Phleum pratense

Poa pratensis

Secale cereale

Key facts

• Active Substance:
  • Lolium perenne
  • Phleum pratense
  • Poa pratensis
  • Secale cereale
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/277/2010
• PIP number:
  EMEA-000905-PIP01-10
• Pharmaceutical form(s):
  Oromucosal drops
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of rhino-conjuctivitis
• Route(s) of administration:
  Sublingual use
• Contact for public enquiries:

  HAL Allergy BV

  [e-mail]; The Netherlands; 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:
  03/12/2010

Decision

P/277/2010: EMA decision of 3 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 allergen extract of 50% grass (equal parts of lolium ...

AdoptedReference Number: EMA/754263/2010