MHRA-100340-PIP01-21-M02 (update)

Key Facts

PIPS Key Facts
Active Substance	Active Substance: LANADELUMAB
Invented Name	TAKHZYRO TAKZHYRO TAKZHRYO TAKHZYRO TAKHZYRO TAKHZYRO TAKZHYRO 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-100340-PIP01-21-M02 (update)
Pharmaceutical form(s)	Pharmaceutical form(s): Solution for injection
Therapeutic area	Therapeutic area: Other: Genetic disease
Conditions / Indications	Conditions / Indications: Prevention of hereditary angioedema attacks
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 PM: decision on the application for modification of an agreed paediatric investigation plan.
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):LANADELUMAB.pdf
Published Date	25/05/2023