Prevenar 20 (previously Apexxnar) (pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed))
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Pneumococcal Infections
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Mon 14 Feb 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005451
- ATC
- J07AL02
- Official record
- www.ema.europa.eu
Indication
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. Apexxnar should be used in accordance with official recommendations.
Regulatory milestones
No milestones recorded in the last year.
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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.