Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| ModernaTX, Inc. | Norwood, MA, United States | Makes the active ingredient and tests it | Not inspected on record |
| Rovi Pharma Industrial Services S.a. | San Sebastián de los Reyes, Spain | Makes it | Problems found, fixed voluntarilyJun 3, 2021 · 1 inspection |
| Moderna Biotech Spain Sl. | Madrid, Spain | Tests it | Not inspected on record |
| ROVI Pharma Industrial Services S.A. | Madrid, Spain | Tests it | Problems found, fixed voluntarilyMar 14, 2024 · 6 inspections |
| Rovi Pharma Industrial Services SA | Alcala de Henares, Spain | Tests it, packages it and labels it | Problems found, fixed voluntarilyJan 17, 2024 · 5 inspections |
Product details
- Generic drug
- Rna-101-Bfl3 and Rna-101-Bfl5 and Rna-101-Bfl6: every company that makes it
- Form
- injection, suspension, intramuscular
- Strength
- 12.5 ug per 0.38 mL
- Approval
- BLA BLA125869
- On the market since
- Aug 5, 2026
- Package NDCs
80777-500-1880777-500-20- Official label
- DailyMed (National Library of Medicine), updated Aug 5, 2026
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