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MR001

Product Details
WHO Product ID
MR001
Status
Prequalified
INN, dosage form and strength
Cefiderocol Powder for concentrate for solution for infusion 1g/vial
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Multi-drug resistant bacterial infections
Type
Finished Pharmaceutical Product
Dosage form
Powder for concentrate for solution for infusion
Reference authority
European Medicines Agency
Applicant organization
Shionogi B.V.
Herengracht 464
Amsterdam,
1017CA
Netherlands
Packaging details and storage conditions
Packaging Type
Vial, Type I glass
Configuration
10x1
Shelf life (months)
36
Storage conditions
Store in a refrigerator (2 °C to 8 °C), protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shionogi Pharma Co., Ltd.
7, Moriyama, Nishine, Kanegasaki-cho, Isawa-gun,
Iwate,
029-4503
Japan
Cefiderocol
FPP Manufacturing Site(s)
Shionogi Pharma Co., Ltd.
7, Moriyama, Nishine, Kanegasaki-cho, Isawa-gun,
Iwate,
029-4503
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 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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