Procomvax
Expired
This medicine's authorisation has expired
haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine
MedicineHumanExpired
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- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Product information
Latest procedure affecting product information:II/0028
11/12/2007
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
- 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
VaccinesTherapeutic 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
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