Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: MODERNA BIOTECH SPAIN, S.L., C/ Julián Camarillo nº 31, 28037 Madrid, Spain
mRESVIA dispersion for injection in pre-filled syringe.
Respiratory Syncytial Virus mRNA vaccine.
| Pharmaceutical Form |
|---|
|
Dispersion for injection. White to off-white dispersion (pH: 7.0 – 8.0). |
Each single-dose pre-filled syringe contains one dose of 0.5 mL.
One dose (0.5 mL) contains 50 micrograms of Respiratory Syncytial Virus (RSV) mRNA vaccine (nucleoside modified) encapsulated in lipid nanoparticles.
The active substance is a single-stranded 5' capped mRNA encoding the RSV-A glycoprotein F stabilised in the prefusion conformation.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Respiratory syncytial virus vaccine is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus. There are three types of RSV vaccine. The first one is a bivalent, recombinant vaccine, containing two recombinant stabilised RSV prefusion F antigens representing subgroups RSV-A and RSV-B. The second one is a RSVPreF3 vaccine which combines the RSV-specific antigen with an adjuvant system (AS01E), designed to enhance antigen-specific cellular immune response and neutralizing antibodies response in individuals with pre-existing immunity against RSV, and an mRNA-based vaccine that stimulates production of RSV-A and RSV-B neutralising antibodies and induction of antigen-specific cellular immune responses. |
| List of Excipients |
|---|
|
SM-102 (Heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate) |
0.5 mL dispersion in a pre-filled syringe (polymeric barrel) with plunger stopper and a rubber tip cap (without needle).
The pre-filled syringe is packaged within a carton in either a tray containing 1 or 10 pre-filled syringes, in 1 clear blister containing 1 pre-filled syringe or in 5 clear blisters containing 2 pre-filled syringes in each blister.
Pack sizes:
10 pre-filled syringes per carton
1 pre-filled syringe per carton
Each pre-filled syringe contains 0.5 mL.
Not all pack sizes may be marketed.
MODERNA BIOTECH SPAIN, S.L., C/ Julián Camarillo nº 31, 28037 Madrid, Spain
EU/1/24/1849/001
EU/1/24/1849/002
EU/1/24/1849/003
EU/1/24/1849/004
Date of first authorisation: 22 August 2024
| Drug | Countries | |
|---|---|---|
| MRESVIA | Austria, Estonia, France, Italy, Lithuania |
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