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

Indicated for: COVID-19

Route of administration: injectable

Substance: tozinameran/riltozinameran Covid-19 mRNA vaccine (with modified nucleosides) (vaccine)

ATC: J07BX03 (Antiinfectives for systemic use | Viral vaccines | Other viral vaccines)

Precautions:
Anaphylaxis
Anaphylaxis

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

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Refrigerated storage
Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

Protect from light
Protect from light

Store protected from light.

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
  • Concentration: 15mcg / 15mcg / dose
  • Pharmaceutical form: dispersion for injection
  • Packing 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
PDF icon EMA leaflet
Published: 12/01/2021
Updated: 29/05/2026