Vaccine/GSK
Measles, Mumps and Rubella Virus Vaccine Live - Priorix
Status: marketed in Europe, Australia and other countries; not approved in the U.S.
Organizations involved:
GlaxoSmithKline Biologicals S.A. (GSK) – Manuf.; R&D; Tech.;
GlaxoSmithKline plc (GSK) – Europe mark.; Parent
Cross ref: See the entry for M-M-R II, the comparable vaccine distributed in the U.S. and the entries for similar related component vaccines – Measles Virus Vaccine Live (Attenuvax); Rubella Vaccine Live (Meruvax II), and Mumps Virus Vaccine Live (Mumpsvax).
Description: Priorix is a lyophilized formulation combining three live vaccines: 1) Measles Virus Vaccine Live, an attenuated live measles virus derived from Schwarz' strain and propagated in chick embryo cell culture; 2) Mumps Virus Vaccine Live, RIT 4385, a type of Jeryl Lynn mumps virus strain propagated in chick embryo cell culture; and 3) Rubella Virus Vaccine Live, Wistar RA 27/3 strain of live attenuated rubella virus propagated in human diploid MRC-5 cells. After mixing with the water, each 0.5 ml dose contains not less than the following amounts of each virus type: 10.sup.3 CCID.sub.50 measles virus (Schwarz strain), 10.sup.3.7 CCID 50 mumps virus (RIT 4385 strain) and 10.sup.3 CCID.sub.50 rubella virus (RA 27/3 strain).
Priorix also contains the inactive ingredients lactose, sorbitol (E420), and the following amino acids; L-alanine, L-arginine, glycine, L-histidine, L-isoleucine, L-leucine, L-lysine HC1, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine, L-aspartic acid, L-cysteine, L-cystine, L-hydroxproline, and mannitol. Priorix may contain very small amounts of neomycin sulfate. Priorix is stored at 2-8˚C (refrigerated). The shelf-life of Priorix is two years.
Companies.: Priorix is manufacture by
Indications: [full text of the "Therapeutic indications:" section of the SPC]:
Priorix is indicated for active immunisation against measles, mumps and rubella.
Status: Approved and marketed in various European countries. Approved in the U.K. in 1997. Not approved through centralized EU/EMEA regulation.
Index Terms:
Companies involvement:
Full monograph
493.5 Measles Mumps & Rubella
Nomenclature:
Measles Mumps & Rubella Vaccine/GSK [BIO]
FDA Class: Biologic BLA
biopharmaceutical products
chicken source materials
human materials used<!-- humansource -->
vaccines, combination
vaccines, live
vaccines, viral
cells, human
chicken embryo (egg) culture
mammalian cell culture
measles prophylaxis
mumps virus Jeryl Lynn strain
rubella virus Wistar Inst. RA 27/3 strain
Sauton medium
air-lift fermenters
arginine
asparagine
cysteine
cystic fibrosis (CF)
glycine
histidine
hydrocortisone
iron ammonium citrate
lactose
leeches, medicinal
Lys-Plasminogen
methanol
neomycin
phenthioate ligand
ProLease microencapsulation
Sepharose, Erythrina trypsin inhibitor (ETI)-
sorbitol
three-demensional cell culture
trypticase soy agar medium
vaginitis
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
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