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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
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)
36
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 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