MHRA-100700-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BIRCH POLLEN
Invented Name
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
PIP Number MHRA-100700-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral lyophilisate
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of allergic rhinitis/ rhino-conjunctivitis
Route(s) of administration
Route(s) of administration:
  • SUBLINGUAL USE
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
14/06/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100700-PIP01-22-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BIRCH POLLEN.pdf
Published Date 15/07/2026