EMEA-002893- PIP01-20-M01

Key facts

Invented name
  • Spikevax (previously COVID-19 Vaccine Moderna)
  • Spikevax
Active substance
mRNA that encodes for the pre-fusion stabilized spike glycoprotein of SARS-CoV-2 (mRNA-1273)
Therapeutic area
  • Infectious diseases
  • Vaccines
Decision number
P/0444/2021
PIP number
EMEA-002893- PIP01-20-M01
Pharmaceutical form(s)
Dispersion for injection
Condition(s) / indication(s)
Prevention of Coronavirus disease 2019 (COVID-19)
Route(s) of administration
Intramuscular use
Contact for public enquiries
MODERNA BIOTECH SPAIN, S.L.

E-mail: Nadia.Assenova@modernatx.com

Tel.  +41 794746697

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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