EMEA-003502-PIP02-24 - paediatric investigation plan
mezagitamab
PIPHuman
Key facts
Active substance
mezagitamab
Therapeutic area
Renal and urinary disorders
Decision number
EMEA-003502-PIP02-24
PIP number
EMEA-003502-PIP02-24
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of primary immunoglobulin A nephropathy
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Takeda Pharmaceuticals International AG Ireland Branch E-mail: medinfoemea@takeda.com Tel: +44 (0) 3333 000181
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Compliance check done
No
Decision
EMEA-003502-PIP02-24 : EMA decision of 28 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mezagitamab