Procomvax

RSS

haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Procomvax has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

This EPAR was last updated on 29/07/2009

Authorisation details

Product details
Name
Procomvax
Agency product number
EMEA/H/C/000231
Active substance
  • polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC
  • outer membrane protein complex of Neisseria meningitidis (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B)
  • adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)
International non-proprietary name (INN) or common name
haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine
Therapeutic area (MeSH)
  • Hepatitis B
  • Meningitis, Haemophilus
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07CA
Publication details
Marketing-authorisation holder
Sanofi Pasteur MSD, SNC
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
07/05/1999
Contact address
Sanofi Pasteur MSD SNC
8 rue Jonas Salk
F-69007 Lyon
FRANCE

Product information

11/12/2007 Procomvax - EMEA/H/C/000231 - II/0028

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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).

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

PROCOMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age.

Assessment history

Changes since initial authorisation of medicine

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