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

05/07/2013
23/04/2024
EU PAS number:
EUPAS4137
Study
Finalised
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Documents
Study protocol
Initial protocol

4016-protocol vers 2.0-redacted

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Updated protocol

4016-protocol-version-6-redacted

First published: 22/02/2024
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Study results
Study results

4016-nsr-nn-trials-redacted

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Study report
Study report

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

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

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

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

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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