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.
Overview of WHO Public Assessment Report (WHOPAR)
BT-CV003
WHOPAR
M
Product name
Tocilizumab
Dosage
20mg/ml (Each vial contains 400mg of tocilizumab in 20mL) - Concentrate for solution for infusion
Laboratory
Roche Registration GmbH
Germany