Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent))
- Region
- 🇪🇺 EU
- Active substance
- pneumococcal polysaccharide conjugate vaccine (21-valent)
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Pneumococcal Infections
- CHMP opinion
- Thu 30 Jan 2025
- EU approval
- Mon 24 Mar 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006267
- ATC
- J07AL02
- Official record
- www.ema.europa.eu
Indication
Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae 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. Capvaxive is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in children and adolescents 2 to less than 18 years of age who previously completed a primary paediatric pneumococcal vaccination regimen. 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.
Regulatory milestones
No milestones recorded in the last year.
Follow Capvaxive
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.