EMEA-002600-PIP01-19-M02 - paediatric investigation plan

Pegcetacoplan
PIPHuman

Key facts

Invented name
Aspaveli
Active Substance
Pegcetacoplan
Therapeutic area
Renal and urinary disorders
Decision number
P/0099/2024
PIP number
EMEA-002600-PIP01-19-M02
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
Treatment of paroxysmal nocturnal haemoglobinuria
Route(s) of administration
Subcutaneous use
Contact for public enquiries

Swedish Orphan Biovitrum AB (publ)

Tel. +46 8697 2000
E-mail: medical.info@sobi.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

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