MHRA-100989-PIP01-23-M01 (update)

Key Facts

Active Substance
  • DERMATOPHAGOIDES FARINAE
  • DERMATOPHAGOIDES PTERONYSSINUS
Invented Name
  • ACARIZAX and associated names
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • AMITEND
  • ACARIZAX
  • AITARO
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACCARIZAX
PIP Number MHRA-100989-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral lyophilisate
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
  • Treatment of asthma
  • Treatment of allergic rhinitis
Route(s) of administration
Route(s) of administration:
  • SUBLINGUAL USE
PIP applicant
  • ALK-Abelló A/S
  • Country Denmark
  • Tel +4545747576
  • Email alkmrp@alk.net
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 Check Procedure Number
Compliance procedure number
MHRA-100989-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DERMATOPHAGOIDES FARINAEDERMATOPHAGOIDES PTERONYSSINUS.pdf
Published Date 30/04/2024