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CV011

Product Details
WHO Product ID
CV011
Status
Prequalified
INN, dosage form and strength
Remdesivir Powder for concentrate for solution for infusion 100 mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Covid-19
Type
Finished Pharmaceutical Product
Dosage form
Powder for concentrate for solution for infusion
Reference authority
European Medicines Agency
Applicant organization
Gilead Sciences Ireland UC
IDA Business & Technology Park, County Cork
Carrigtohill,
Ireland
Packaging details and storage conditions
Packaging Type
Type 1 clear glass vial, an elastomeric closure, and an aluminium overseal with a flip-off cap
Configuration
1 vial
Shelf life (months)
48
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Remdesivir
Cambrex Charles City
1205 11th Street
Charles City,
Iowa
50616
United States of America
Remdesivir
Esteve Huayi Pharmaceutical Co., Ltd
Linhai Road, Shaoxing Paojiang Industrial Zone, Yuecheng District
Zhejiang
312071
China
Remdesivir
Eurofins Lancaster Laboratories, Inc
2425 New Holland Pike, Lancaster
PA 17601
United States
Remdesivir
Fabbrica Italiana Sintetici S.p.A. (F.I.S.)
Viale Milano 26, Alte di Montecchio Maggiore
Vicenza,
36075
Italy
Remdesivir
Gilead Alberta, ULC
1021 Hayter Road, Alberta
Edmonton,
T6S 1A1
Canada
Remdesivir
Gilead Sciences Inc.
650 Cliffside Drive
San Dimas,
CA 91773
United States
Remdesivir
SGS Canada Inc
6490 Vipond Drive
Mississauga,
Ontario
L5T 1W8
Canada
Remdesivir
FPP Manufacturing Site(s)
Anderson Brecon Inc
4545 Assembly Drive
Rockford,
61109
United States of America
Charles River Laboratories Preclinical Services Ireland, Ltd
Carrentrila, Ballina,
Ireland
Eurofins Biopharma Product Testing Ireland Limited
Clogherane
Dungarvan, Co,
0
Ireland
Eurofins Lancaster Laboratories, Inc
2425 New Holland Pike, Lancaster
PA 17601
United States
Gilead Sciences, Inc.
1800 Wheeler Avenue, La Verne
California,
91750
United States
Hospira, Inc
1776 North Centennial Drive
McPherson,
KS 67460
United States
Jubilant HollisterStier LLC
3525 North Regal Street, Spokane
Washington,
99207
United States
Millmount Healthcare Ltd
Block-7, Stamullen
City North Business Campus,
Ireland
Patheon Manufacturing Services LLC
5900 Martin Luther King Jr. Hwy, P.O. Box 1887, Greenville
NC 27834
United States
Patheon Italia S.p.A
Viale Gian Battista Stucchi 110, Monza
20900
Italy
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 7

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