Medicine information COMIRNATY COVID-19 VACCIN 10mcg / dose concentrate for dispersion for injection

Product code:
W68305001
Quantity:
10
Indicated for:
COVID-19
Route of administration:
injectable
ATC
J07BX03 — Antiinfectives for systemic use | Viral vaccines | Other viral vaccines
mRNA COVID-19 vaccines (with modified nucleosides) are used to prevent infection with the SARS-CoV-2 virus, which causes COVID-19. These vaccines contain a fragment of messenger RNA (mRNA) that encodes the virus's spike protein. After administration, host cells use the mRNA to produce the spike protein, which stimulates the immune system to generate an immune response, including specific antibodies.

mRNA vaccines are administered intramuscularly, usually in two doses, spaced 3-4 weeks apart, depending on the manufacturer. They are recommended for all eligible age groups, including individuals at high risk of severe COVID-19 complications.

Common side effects include pain at the injection site, fatigue, fever, muscle aches, and headaches. In rare cases, severe adverse reactions such as myocarditis, pericarditis, or allergic reactions may occur.

mRNA COVID-19 vaccines represent a major innovation in vaccinology, providing effective protection against SARS-CoV-2 infection and reducing the severity of the disease and associated complications.

General data about COMIRNATY COVID-19 VACCIN 10mcg / dose

Substance:
COVID-19 mRNA vaccine (with modified nucleosides)
Date of latest medicines list:
01-01-2022
Product code:
W68305001
Strength:
10mcg / dose
Pharmaceutical form:
concentrate for dispersion for injection
Pack volume:
1,3 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:
1528/2020/04
Shelf life:
Flacon unopened/ 9 months- flaconul congelat; 10 weeks - flaconul decongelat

Pharmaceutical forms available for COVID-19 mRNA vaccine (with modified nucleosides)

Strengths available for COVID-19 mRNA vaccine (with modified nucleosides)

  • 100mcg/dose
  • 10mcg/dose
  • 30mcg/dose
  • 50mcg/dose

Official documents

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

Added to database:
12/01/2021
Source record 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.