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BT-EB001

Product Details
WHO Product ID
BT-EB001
Status
Prequalified
INN, dosage form and strength
Atoltivimab/Maftivimab/Odesivimab Solution for Infusion 16.67 mg/mL/16.67 mg/mL/16.67 mg/mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Ebola
Type
Biotherapeutic Product
Dosage form
Solution for Infusion
Reference authority
United States Food and Drug Administration
Applicant organization
Regeneron Pharmaceuticals Inc.
777 Old Saw Mill River Road
Tarrytown,
New York
10591-6707
United States of America
Packaging details and storage conditions
Packaging Type
Vial, Type I glass
Configuration
1 x 20mL (14.5 mL per vial)
Shelf life (months)
54
Storage conditions
Store in a refrigerator (2 °C to 8 °C), do not freeze, protect from light
FPP Manufacturing Site(s)
Regeneron Pharmaceuticals Inc.
777 Old Saw Mill River Road
Tarrytown,
New York
10591-6707
United States of America
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 6 - 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 6 , Part 7

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