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BT-ON001

Product Details
WHO Product ID
BT-ON001
Status
Prequalified
INN, dosage form and strength
Trastuzumab Powder for concentrate for solution for infusion 150 mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Oncology
Type
Biotherapeutic Product
Dosage form
Powder for concentrate for solution for infusion
Reference authority
European Medicines Agency
Applicant organization
Samsung Bioepis NL B.V.
Olof Palmestraat 10
Delft,
2616 LR
Netherlands
Packaging details and storage conditions
Packaging Type
Vial, 15ml type I borosilicate glass
Configuration
1X1
Shelf life (months)
48
Storage conditions
Store in a refrigerator (2 °C to 8 °C)
FPP Manufacturing Site(s)
Biogen Manufacturing ApS
Biogen Allé, 1
Hillerød,
3400
Denmark
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 6b - 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 6b , Part 7

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