EMA — authorised 24 March 2025
- Application: EMEA/H/C/006267
- Marketing authorisation holder: Merck Sharp & Dohme B.V.
- Local brand name: Capvaxive
- Indication: Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.The use of Capvaxive should be in accordance with official recommendations.
- Status: approved
The European Medicines Agency (EMA) has approved Capvaxive (PCV21) for active immunisation against invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. This approval is based on a standard application pathway. The vaccine is indicated for use in accordance with official recommendations. The marketing authorisation holder is Merck Sharp & Dohme B.V.