EMEA-000857-PIP01-10-M01 - paediatric investigation plan

Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Anthoxhantum odoratum (16 %) and Secale cereale (20%)

Key facts

• Active Substance:
  Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Anthoxhantum odoratum (16 %) and Secale cereale (20%)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0279/2015
• PIP number:
  EMEA-000857-PIP01-10-M01
• Pharmaceutical form(s):
  Oromucosal solution
• Condition(s) / indication(s):
  • Treatment of allergic rhinitis
  • Treatment of rhino-conjuctivitis
• Route(s) of administration:
  Sublingual use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/11/2015

Decision

P/0279/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for pollen from Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis, Anthoxhantu...

AdoptedReference Number: EMA/690862/2015