Licensed vaccine
MRESVIA
FDA-licensed vaccine · ModernaTX, Inc. · STN 125796
Key facts
| Trade name | MRESVIA |
|---|---|
| Proper name | Respiratory Syncytial Virus Vaccine |
| Manufacturer | ModernaTX, Inc. |
| Submission tracking number (STN) | 125796 |
| FDA product areas | Biologics |
| Recent FDA documents | December 23, 2024 Approval Letter - MRESVIA, October 3, 2024 Approval Letter - MRESVIA, Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (MRESVIA)Refer to Section 1.1 of the Clinical Review Memo for informa, Approval History, Letters, Reviews, and Related Documents - MRESVIA, May 31, 2024 Summary Basis for Regulatory Action - MRESVIA, June 14, 2024 Approval Letter - MRESVIA, Package Insert - MRESVIA |
| FDA page updated | Dec 26, 2024 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 1–9 Supporting documents
- 1–9 Product information documents
- Yes Document full text searchable in Orca1
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-licensed vaccines
The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.
Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date: