Vaccine/GSK
Measles and Rubella Virus Vaccine Live - MoRu-Viraten
Status: marketed in European countries
Organizations involved:
Crucell N.V. – Manuf.; Intl. mark.
Berna Biotech Ltd. – R&D; Tech.; Former
Cross ref.: See the entries for Measles & Rubella Virus Vaccine/Merck (M-R-Vax II), and its related vaccines.
Description: MoRu-Viraten is a lyophilized (freeze-dried) formulation of a bivalent combination vaccine containing a highly attenuated live measles virus cultured in chicken embryos (eggs) and and live rubella virus (RA27/3 strain) cultured in a human diploid cell line. Each sterile, lyophilized preparation, contains: 31,000 TCID50 (tissue culture infectious dose) of each vaccine virus. The vaccine is antibiotic-, avian protein- and preservative-free.
The vaccine is packaged in single dose vials of 0.5 mL, in boxes of 1, 10 and 50, together with 1, 10 and 50 vials of diluent respectively. Each diluent vial contains 0.5 mL of sterile water for injection, USP. The vaccine is store refrigerated at 2-8°C.
MoRu-Viraten has been reported to contain gelatin (either bovine or porcine source), lactalbumin and lactose (but this with many or most European biopharmaceuticals having all animal-origin materials removed in recent years, it may no longer contain gelatin).
Nomenclature: Measles & Rubella Virus Vaccine/Crucell [BIO]; MoRu-Viraten [TR Europe]; Measles and Rubella Virus Vaccine Live [SY]
Companies.: MoRu-Viraten was originally developed, manufactured and marketed by Berna Biotech Ltd.. which was acquired by Crucell N.V. in fall 2006. The vaccine is now manufactured by Crucells and marketed in Europe and other countries, including Canada, by Crucell.
Status: The vaccine has been marketed since 1986 and is on the WHO list of prequalified vaccines for purchase by UN agencies.
Medical: MoRu-Viraten is safe, well-tolerated and effective for protection against measles and rubella in children, adolescents and adult. In children is it used for for the simultaneous immunization against measles and rubella in individuals 12 to 15 months of age or older. A booster dose of either MoRu-Viraten Berna vaccine, monovalent measles vaccine or trivalent measles, mumps and rubella vaccine is recommended Children younger than 12 months of age when first vaccinated should be revaccinated at 15 months of age followed by another at 4 to 6 years of age. Susceptible nonpregnant adolescent and adult females of childbearing age should be immunized with this or another a vaccine containing live attenuated rubella virus as long as certain precautions are observed.
Index Terms:
Companies involvement:
Full monograph
494.5 Measles & Rubella Virus
Nomenclature:
Measles & Rubella Virus Vaccine/Crucell [BIO]
MoRu-Viraten [TR Europe]
Measles and Rubella Virus Vaccine Live [SY]
FDA Class: Biologic BLA
angioplasty
biopharmaceutical products
human materials used<!-- humansource -->
live microorganisms (as active agent)
vaccines, combination
vaccines, live
vaccines, viral
cells, human
chicken embryo (egg) culture
human chorionic gonadotropin (hCG)
RA 27/3 Wistar Inst. strain, rubella virus
rubella virus Wistar Inst. RA 27/3 strain
virus culture
Gb-23-902-531
lacI9 gene (Amersham)
lactose
North American coral snake
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM001 Marketed Product in EU
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