EMEA-002597-PIP10-23 - paediatric investigation plan
Efgartigimod alfa
PIPHuman
Key facts
- Invented name
- Vyvgart
- Active Substance
- Efgartigimod alfa
- Therapeutic area
- Eye disorders
- Decision number
- P/0111/2024
- PIP number
- EMEA-002597-PIP10-23
- Pharmaceutical form(s)
- Concentrate for solution for infusion
- Solution for injection
- Condition(s) / indication(s)
- Treatment of thyroid eye disease
- Route(s) of administration
- Intravenous use
- Subcutaneous use
- Contact for public enquiries
Argenx BV
E-mail: regulatory@argenx.com
Tel: +32 93103400- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date