Medicine information COMIRNATY COVID-19 VACCIN 15mcg / 15mcg / dose dispersion for injection

Product code:
W69194001
Quantity:
10
Pack volume:
2,25 ml
Indicated for:
COVID-19
Route of administration:
injectable
ATC
J07BX03 — Antiinfectives for systemic use | Viral vaccines | Other viral vaccines
Tozinameran-riltozinameran is an mRNA-based vaccine used for the prevention of SARS-CoV-2 infection, the causative agent of COVID-19. It contains mRNA encoding the viral spike protein, encapsulated in a lipid nanoparticle to facilitate cellular delivery.

The vaccine works by stimulating the immune system to produce antibodies and activate T-cells against the spike protein, providing protection against infection and severe disease. It is administered intramuscularly, typically in two doses several weeks apart.

Common side effects include pain at the injection site, fatigue, headache, fever, and chills. In rare cases, severe adverse reactions such as myocarditis, pericarditis, or allergic reactions may occur. Post-vaccination monitoring is essential to promptly identify and manage these reactions.

Tozinameran-riltozinameran represents an innovative technology in COVID-19 prevention, significantly contributing to reducing virus transmission and protecting public health.

General data about COMIRNATY COVID-19 VACCIN 15mcg / 15mcg / dose

Substance:
tozinameran/riltozinameran Covid-19 mRNA vaccine (with modified nucleosides)
Date of latest medicines list:
01-11-2022
Product code:
W69194001
Strength:
15mcg / 15mcg / dose
Pharmaceutical form:
dispersion for injection
Pack volume:
2,25 ml
Product type:
Original
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
BIONTECH MANUFACTURING GMBH/ PFIZER MANUFACTURING - GERMANIA/BELGIA
Holder:
BIONTECH MANUFACTURING GMBH - GERMANIA
Number:
1528/2020/06
Shelf life:
Flacon unopened/ 12 months- flaconul congelat; 10 weeks - flaconul decongelat

Official documents

The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.

The correspondence between the document and the displayed text is unconfirmed.

Source institution
EMA
Document language
English
Source record: first published
12/01/2021
Source record: last updated
06/08/2026

Warnings:

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring

This medicine is subject to additional monitoring.

Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

Protect from light

Store protected from light.