FDA — authorised 16 March 2007
- Application: BLA125166
- Marketing authorisation holder: ALEXION PHARM
- Local brand name: SOLIRIS
- Indication: INJECTABLE — IV (INFUSION)
- Status: approved
🇺🇸 Eculizumab Injection in United States
FDA authorised Eculizumab Injection on 16 March 2007
Marketing authorisation
Eculizumab Injection in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Eculizumab Injection approved in United States?
Yes. FDA authorised it on 16 March 2007.
Who is the marketing authorisation holder for Eculizumab Injection in United States?
ALEXION PHARM holds the US marketing authorisation.