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BT-ON013

WHO Product ID
BT-ON013
Status
Prequalified
INN, dosage form and strength
Trastuzumab Powder for concentrate for solution for infusion 150mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Oncology
Type
Biotherapeutic Product
Dosage form
Powder for concentrate for solution for infusion
Applicant organization
Biocon Biologics Limited
16 Great Queen Street, Covent Garden
London,
WC2B 5AH
United Kingdom of Great Britain and Northern Ireland
Packaging details and storage conditions
Packaging Type
Vial, type I glass + Vial, type 1 glass
Configuration
150mg lyophilized powder (Trastuzumab) in 15mL vial + 10mL bacteriostatic water for injection in 10mL vial
Shelf life (months)
48
Storage conditions
Store in a refrigerator (2 °C to 8 °C)
API Manufacturing Site(s)
By Organization
By Active Ingredient
Biocon Biologics Limited
Special Economic Zone, Plot Nos. 2, 3, 4 & 5 - Phase-IV, Bommasandra-Jigani Link Road, Bommasandra Post
Bangalore,
560 099
India
Trastuzumab
Charles River Laboratories, Inc. (Bulk harvest testing)
358 Technology Drive
Malvern,
19355
United States of America
Trastuzumab
FPP Manufacturing Site(s)
By Organization
By Active Ingredient
Biocon Biologics Limited
Special Economic Zone, Plot Nos. 2, 3, 4 & 5 - Phase-IV, Bommasandra-Jigani Link Road, Bommasandra Post
Bangalore,
560 099
India
Trastuzumab
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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