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BT-DM006

Product Details
WHO Product ID
BT-DM006
Status
Prequalified
INN, dosage form and strength
Insulin Glargine Solution for injection 100 U/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
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, Brüningstraße 50
Frankfurt am Main,
65926
Germany
Packaging details and storage conditions
Packaging Type
Cartridge, Type I colourless glass, black plunger bromobutyl rubber
Configuration
3mLx1, 3mLx3, 3mLx4, 3mLx5, 3mLx6, 3mLx8, 3mLx9, 3mLx10
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
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, Brüningstraße 50
Frankfurt am Main,
65926
Germany
Insulin Glargine
FPP Manufacturing Site(s)
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, Brüningstraße 50
Frankfurt am Main,
65926
Germany
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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