MHRA-100832-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • LANADELUMAB
Invented Name
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
PIP Number MHRA-100832-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection.
Therapeutic area
Therapeutic area:
  • Other: Genetic disease
Conditions / Indications
Conditions / Indications:
  • Prevention of attacks of idiopathic non-histaminergic angioedema (INHA).
Route(s) of administration
Route(s) of administration:
  • SUBCUTANEOUS USE.
PIP applicant
  • Takeda Pharmaceuticals International AG Ireland Branch
  • Country Ireland
  • Tel 03333000181
  • Email medinfoemea@takeda.com
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LANADELUMAB.pdf
Published Date 24/08/2023