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BT-DM001

Product Details
WHO Product ID
BT-DM001
Status
Prequalified
INN, dosage form and strength
Insulin Human Solution for injection 100IU/ml
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Diabetes
Type
Biotherapeutic Product
Dosage form
Solution for injection
Reference authority
European Medicines Agency
Applicant organization
Novo Nordisk AS
Novo Allé 1
Bagsværd,
2880
Denmark
Packaging details and storage conditions
Packaging Type
Vial, Type I glass
Configuration
10mL vialx1, 10mL vialx5
Shelf life (months)
30
Storage conditions
Store in a refrigerator (2 °C to 8 °C)
API Manufacturing Site(s)
By Organization
By Active Ingredient
Novo Nordisk AS
Novo Allé 1
Bagsværd,
2880
Denmark
Insulin Human
Novo Nordisk AS
Hallas Allé 1
Kalundborg,
DK-4400
Denmark
Insulin Human
FPP Manufacturing Site(s)
Novo Nordisk AS
Novo Allé 1
Bagsværd,
2880
Denmark
Novo Nordisk Production SAS
45, Avenue d’Orléans
Chartres,
F-28000
France
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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