Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: BioNTech Manufacturing GmbH, An der Goldgrube 12, 55131 Mainz, Germany Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de
Comirnaty 30 micrograms/dose concentrate for dispersion for injection.
COVID-19 mRNA Vaccine (nucleoside modified).
| Pharmaceutical Form |
|---|
|
Concentrate for dispersion for injection (sterile concentrate). The vaccine is a white to off-white frozen dispersion (pH: 6.9-7.9). |
This is a multidose vial and must be diluted before use.
One vial (0.45 mL) contains 6 doses of 0.3 mL after dilution, see sections 4.2 and 6.6.
One dose (0.3 mL) contains 30 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles).
Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tozinameran |
The nucleoside-modified messenger RNA in COVID-19 mRNA Vaccine BNT162b2 is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. |
| List of Excipients |
|---|
|
((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) |
0.45 mL concentrate in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a purple flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see section 6.6.
Pack size: 195 vials.
BioNTech Manufacturing GmbH, An der Goldgrube 12, 55131 Mainz, Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.de
EU/1/20/1528/001
Date of first authorisation: 21 December 2020
Date of latest renewal: 03 November 2021
| Drug | Countries | |
|---|---|---|
| COMIRNATY | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, United Kingdom, United States, South Africa |
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