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Logo PRIORIX TETRA®

For full prescribing information refer to the package insert approved by the medicines regulatory authority.

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PRIORIX TETRA®
Powder and diluent for solution for injection

COMPOSITION:
Measles, mumps, rubella and varicella vaccine (live, attenuated). Powder and diluent for solution for injection.
After reconstitution, 1 dose (0,5 mL) contains:
Live attenuated measles virus
1 (Schwarz strain): not less than 103,0 CCID50 3 ;
Live attenuated mumps virus 1 (RIT 4385 strain, derived from Jeryl Lynn strain): not less than 10
4,4 CCID50 3 ;
Live attenuated rubella virus
2 (Wistar RA 27/3 strain): not less than 103,0 CCID50 3 ;
Live attenuated varicella virus
2 (OKA strain): not less than 103,3
PFU4. 1 produced in chick embryo cells; 2 produced in human diploid (MRC-5) cells; 3
Cell culture Infective Dose 50%; 4 plaque forming units.

ATC CLASSIFICATION:
no data

PRESENTATION/PACK SIZE:
no data

REGISTRATION NUMBER:
43/30.1/0127.

APPLICANT:
GlaxoSmithKline South Africa (Pty) Ltd.
(Co. Reg. no.: 1948/030135/07),
57 Sloane Street,
Bryanston,
2021.

MARKETED BY
Aspen Pharmacare, Building 12, Healthcare Park, Woodlands Drive, Woodmead, 2191

AVAILABILITY:
Please check with company.

DATE OF REGISTRATION:
no data

Date posted: September 2014

FURTHER READING:
International Links
: (cut and paste the URL)
NOTE -These links are for reference only and may not apply to the registration criteria pertaining to The Medicines Control Council in South Africa.
EMC: http://www.medicines.org.uk/emc/medicine/2054/SPC
GSK Canada: http://www.gsk.ca/english/docs-pdf/product-monographs/Priorix-tetra.pdf
[This document plus the full product monograph, prepared for health professionals can be found at: http://www.gsk.ca]
Pharmafile: http://www.pharmafile.com/news/182198/gsk-halts-chickenpox-vaccines-over-quality-concerns [Published on 29/01/14 at 01:48pm]


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