EMEA-000859-PIP01-10 - paediatric investigation plan

Pollen from Dactylis glomarata (8%), Lolium perenne (8%), Phleum pratense (8%), Poa pratensis (8%), Anthoxhantum odoratum (8%), Secale cereale (10%), Betula pendula (16.7%), Corylus avellana (16.6%) and Alnus glutinosa (16.6%)

Key facts

• Active Substance:
  Pollen from Dactylis glomarata (8%), Lolium perenne (8%), Phleum pratense (8%), Poa pratensis (8%), Anthoxhantum odoratum (8%), Secale cereale (10%), Betula pendula (16.7%), Corylus avellana (16.6%) and Alnus glutinosa (16.6%)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/301/2010
• PIP number:
  EMEA-000859-PIP01-10
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  • Treatment of rhino-conjuctivitis
  • Treatment of allergic rhinitis
• 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:
  22/12/2010

Decision

P/301/2010: EMA decision of 22 December 2010 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for pollen from dactylis glomarata (8%), lolium perenne (8%), phleum pratense (8%),...

AdoptedReference Number: EMA/683424/2010