Prevenar
pneumococcal saccharide conjugated vaccine, adsorbed
Table of contents
Overview
The marketing authorisation for Prevenar has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Prevenar
|
| Agency product number |
EMEA/H/C/000323
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
pneumococcal saccharide conjugated vaccine, adsorbed
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07AL02
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Pfizer Limited
|
| Revision |
23
|
| Date of issue of marketing authorisation valid throughout the European Union |
02/02/2001
|
| Contact address |
Ramsgate Road
Sandwich Kent CT13 9NJ United Kingdom |
Product information
22/06/2015 Prevenar - EMEA/H/C/000323 - PSUSA/00002452/201408
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Vaccines
Therapeutic indication
Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.
The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.