Gamifant (emapalumab)
OrphanPRIME
- Region
- 🇪🇺 EU
- Active substance
- emapalumab
- Company
- Swedish Orphan Biovitrum AB (publ)
- Status
- Refused
- Therapeutic area
- Immune System Diseases
- CHMP opinion
- Thu 17 Sep 2020
- Designations
- Orphan, PRIME
- Application
- EMEA/H/C/004386
- ATC
- L04AA39
- Official record
- www.ema.europa.eu
Indication
Gamifant is indicated for the treatment of paediatric patients aged under 18 years with primary haemophagocytic lymphohistiocytosis (HLH).
Regulatory milestones
No milestones recorded in the last year.
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