Procomvax

Expired

This medicine's authorisation has expired

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

Overview

Sanofi Pasteur MSD S.N.C., the marketing authorisation holder (MAH) for Procomvax, has decided, for commercial reasons, not to apply for the second renewal of the marketing authorisation for this medicinal product. Consequently, the marketing authorisation for Procomvax expired on 14 May 2009. The MAH has confirmed that this decision is not related to any safety concerns. 

Procomvax (Haemophilus influenzae type b and hepatitis B vaccine) was 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 six weeks to 15 months of age. It was authorised by the European Commission on 7 May 1999. 

The marketing authorisation was first renewed for five years on 14 May 2004. Alternative vaccines containing the same active substances as Procomvax are available throughout the European Union.

Procomvax : EPAR - Summary for the public

Product information

Procomvax : EPAR - Product Information

Procomvax : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Procomvax
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000231
• Marketing authorisation holder:
  Sanofi Pasteur MSD, SNC

  Sanofi Pasteur MSD SNC; 8 rue Jonas Salk; F-69007 Lyon; FRANCE

• Marketing authorisation issued:
  07/05/1999
• Expiry of marketing authorisation:
  14/05/2009
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Procomvax : EPAR - Procedural steps taken and scientific information after authorisation

Procomvax : EPAR - Steps taken after authorisation when a cutoff date has been used

Procomvax-H-C-231-A20-20-SC : EPAR - Scientific Conclusion

Adopted

Initial marketing authorisation documents

Procomvax : EPAR - Procedural steps taken before authorisation

Procomvax : EPAR - Scientific Discussion