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BT-CV001

Product Details
WHO Product ID
BT-CV001
Status
Prequalified
INN, dosage form and strength
Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 80 mg of tocilizumab in 4 mL)
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Covid-19
Type
Biotherapeutic Product
Dosage form
Concentrate for solution for infusion
Reference authority
European Medicines Agency
Applicant organization
Roche Registration GmbH
Emil-Barell-Strasse
Grenzach-Wyhlen,
79639
Germany
Packaging details and storage conditions
Packaging Type
Glass vial, 10 mL Colorless type 1 neutral glass
Configuration
4 vials of 4 mL
Shelf life (months)
30
Storage conditions
Store in a refrigerator (2 °C to 8 °C), do not freeze, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Genentech Inc.
1000 New Horizons Way
Vacaville,
95688
United States
Tocilizumab
Genentech, Inc.
1 Antibody Way
Oceanside,
92056 5802
United States
Tocilizumab
Samsung BioLogics
300, Songdo Bio Way (Daero), Yeonsu-gu
Incheon,
21987
Korea, Rep.
Tocilizumab
FPP Manufacturing Site(s)
Chugai Pharma Manufacturing Co., Ltd.
16-3 Kiyohara Kogyodanchi
Utsunomiya,
Tochigi
321-3231
Japan
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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