MHRA-102114-PIP01-25

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Standardised allergen extract of peanut kernels (Arachis hypogaea)
Invented Name
Not available at present
PIP Number MHRA-102114-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Sublingual lyophilisate
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of peanut allergy
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
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Standardised allergen extract of peanut kernels (Arachis hypogaea).pdf
Published Date 04/09/2026