SPIKEVAX INJECTION DISPERSION 100mcg / dose dispersion for injection medication leaflet

J07BX03 COVID-19 mRNA vaccine (with modified nucleosides) • 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 SPIKEVAX INJECTION DISPERSION 100mcg / dose

Substance: COVID-19 mRNA vaccine (with modified nucleosides)

Date of last drug list: 01-09-2021

Commercial code: W67772001

Concentration: 100mcg / dose

Pharmaceutical form: dispersion for injection

Quantity: 10

Product type: original

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: ROVI PHARMA INDUSTRIAL SERVICES, S.A. - SPANIA

Holder: MODERNA BIOTECH SPAIN, S.L - SPANIA

Number: 1507/2021/01

Shelf life: 7 months- unopened bottle, at a temperature between -25ºC and -15ºC

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

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

100mcg/dose, 10mcg/dose, 30mcg/dose, 50mcg/dose
PDF icon EMA leaflet
Published: 20/01/2021
Updated: 24/02/2026

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