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BT-ON003

Product Details
WHO Product ID
BT-ON003
Status
Prequalified
INN, dosage form and strength
Trastuzumab Powder for concentrate for solution for infusion 420mg
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
Celltrion Inc.
20, Academy-ro 51 beon-gil
Yeonsu-gu,
Incheon-gwangyeoksi
22014
Korea, Rep.
Packaging details and storage conditions
Packaging Type
Vial, 50 mL clear glass type I
Configuration
1x1
Shelf life (months)
72
Storage conditions
Store in a refrigerator (2 °C to 8 °C)
FPP Manufacturing Site(s)
Celltrion Inc.
20, Academy-ro 51 beon-gil
Yeonsu-gu,
22014
Korea, Rep.
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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