← Drug database

Prevenar 13 (pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed))

Region

🇪🇺 EU

Active substance

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Company

Pfizer Europe MA EEIG

Status

Authorised

Therapeutic area

Pneumococcal Infections; Immunization

CHMP opinion

Thu 24 Sep 2009

EU approval

Wed 09 Dec 2009

Application

EMEA/H/C/001104

ATC

J07AL02

Official record

www.ema.europa.eu

Indication

Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ?18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

Regulatory milestones

No milestones recorded in the last year.

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.