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
E-mail: medical.info@sobi.com
Tel. +46 8697 2000- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date