EPARs human use - Procomvax//Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b

FICHA FARMACOLÓGICA de Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. MAYO 30, 2009.-

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EPARs for authorised medicinal products for human use - Procomvax

Active Substance
Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC
Neisseria meningitidis OMPC (outer membrane protein complex 125 µg of the B11 strain of Neisseria meningitidis subgroup B)
Adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)
International Nonproprietary Name or Common Name
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
Pharmaco-therapeutic Group
Bacterial and viral vaccines, combined
ATC Code
J07CA

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.

Date of issue of Marketing Authorisation valid throughout the European Union
7 May 1999