EMEA-001016-PIP01-10-M01 - paediatric investigation plan

chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis

Key facts

• Active substance:
  chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0084/2019
• PIP number:
  EMEA-001016-PIP01-10-M01
• Pharmaceutical form(s):
  Coated tablet
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• Route(s) of administration:
  Sublingual use
• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  22/03/2019
• Compliance check done:
  No

Decision

P/0084/2019: EMA decision of 22 March 2019 on the refusal of a modification of an agreed paediatric investigation plan for chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis (EMEA-001016-PIP01-10-M01)

Adopted Reference Number: EMA/130559/2019