WHO Product ID
BT-CV002
Status
Prequalified
INN, dosage form and strength
Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 200 mg of tocilizumab in 10 mL)
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Covid-19
Type
Biotherapeutic Product
Dosage form
Concentrate for solution for infusion
Applicant organization
Roche Registration GmbH
Emil-Barell-Strasse
Grenzach-Wyhlen,
79639
Germany
Packaging details and storage conditions
Packaging Type
Glass vial, 20 mL Colorless type 1 neutral glass
Configuration
4 vials of 10 mL
Shelf life (months)
36
API Manufacturing Site(s)
By Organization
By Active Ingredient
Genentech Inc.
1000 New Horizons Way
Vacaville,
95688
United States of America
Tocilizumab
Genentech, Inc.
1 Antibody Way
Oceanside,
92056 5802
United States of America
Tocilizumab
Samsung BioLogics
300, Songdo Bio Way (Daero), Yeonsu-gu
Incheon,
21987
Republic of Korea
Tocilizumab
FPP Manufacturing Site(s)
Chugai Pharma Manufacturing Co., Ltd.
16-3 Kiyohara Kogyodanchi
Utsunomiya,
Tochigi
321-3231
Japan