NN304-4016 An international non-interventional prospective cohort study to evaluate the safety of treatment with Levemir® (insulin detemir) in pregnant women with diabetes mellitus

First published 05/07/2013

Last updated 23/04/2024

EU PAS number:

EUPAS4137

Study

Finalised

Documents

Study protocol

Initial protocol

4016-protocol vers 2.0-redacted

English (461.68 KB - PDF)View document

Updated protocol

4016-protocol-version-6-redacted

First published: 22/02/2024

English (452.15 KB - PDF)View document

Study results

4016-nsr-nn-trials-redacted

English (3.54 MB - PDF)View document

Study report

4016-eu-regulatory-annual-report-20151101-20161031

English (144.5 KB - PDF)View document

4016-eu-regulatory-annual-report-20161101-20171031

English (145.17 KB - PDF)View document

4016-eu-regulatory-annual-report-20171101-20181031

English (175.83 KB - PDF)View document

4016-eu-regulatory-study-progress-report-20141101-20151031

English (145.61 KB - PDF)View document

Other information

Study, other information

4016-eu-regulatory-annual-report-20161101-20171031.pdf

English (145.17 KB - PDF)View document

4016-eu-regulatory-annual-report-20171101-20181031.pdf

English (175.83 KB - PDF)View document

4016-eu-regulatory-study-progress-report-20141101-20151031.pdf

English (145.61 KB - PDF)View document

Secondary tabs