Triacelluvax

Application under evaluation
CHMP opinion
European Commission decision

Overview

On 11 January 1999, the European Commission granted a marketing authorisation for the whole European Union to Chiron S.p.A for Triacelluvax (Combined diphtheria, tetanus and acellular pertussis vaccine), indicated for active immunisation of children from 6 weeks up to 7 years of age against diphtheria, tetanus and pertussis.

Triacelluvax was only marketed in Italy. On 15 October 2001, the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Marketing Authorisation for Triacelluvax for commercial reasons. Alternatives are available in Europe, either as individual or combined vaccines.

On 28 January 2002, the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use “Triacelluvax”. Pursuant to this decision, the European Public Assessment Report for Triacelluvax has been removed from this website.

Product information

28/01/2002

This medicine’s product information is available in all official EU languages.
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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).

Product details

Name of medicine

Triacelluvax

Active substance

Diphtheria toxoid
haemagglutinin filamentous
pertussis pertactin
pertussis toxin
tetanus toxoid

International non-proprietary name (INN) or common name

diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed)

Therapeutic area (MeSH)

Immunization
Tetanus
Whooping Cough
Diphtheria

Anatomical therapeutic chemical (ATC) code

J07AJ

Pharmacotherapeutic group

Vaccines

Therapeutic indication

TRIACELLUVAX is indicated for active immunisation of children from 6 weeks up to 7 years of age against diphtheria, tetanus and pertussis.

Authorisation details

EMA product number: EMEA/H/C/000181
Marketing authorisation holder: Chiron S.p.A.
CHIRON S.p.A.,
Via Fiorentina 1,
53100, Siena
Italy
Marketing authorisation issued: 11/01/1999
Withdrawal of marketing authorisation: 28/01/2002

This page was last updated on 03/07/2002

Withdrawn