EMEA-001881-PIP01-15 - paediatric investigation plan

Ragweed pollen extract (Ambrosia artemisiifolia)

Key facts

• Active Substance:
  Ragweed pollen extract (Ambrosia artemisiifolia)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0266/2016
• PIP number:
  EMEA-001881-PIP01-15
• Pharmaceutical form(s):
  Oral lyophilisate
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• Route(s) of administration:
  Sublingual use
• Contact for public enquiries:

  ALK Abelló A/S

  Denmark; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  05/10/2016
• Compliance procedure number:
  EMEA-C-001881-PIP01-15
• Compliance opinion date:
  15/11/2019
• Compliance outcome:
  Positive

Decision

P/0266/2016: EMA decision of 5 October 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ragweed pollen extract (Ambrosia artemisiifolia) (EME...

AdoptedReference Number: EMA/576571/2016