Long-Term Post-Marketing Observational Study of the Safety of Roflumilast

First published 22/08/2016

Last updated 02/04/2024

EU PAS number:

EUPAS14852

Study

Finalised

Documents

Study protocol

Initial protocol

RO-2455-403-RD_ProtocolVersion2.4-31Jul13

English (285.69 KB - PDF)View document

Updated protocol

D7120R00003_ProtocolVersion3_updated20170207

First published: 22/02/2024

English (443.37 KB - PDF)View document

Study results

DAXAS Final Study Report_Redacted_Reduced

English (1.85 MB - PDF)View document

Study report

DAXAS Final Study Report Addendum (NOR)_Redacted

English (8.6 MB - PDF)View document

Other information

ENCePP Seal

ENCePP Seal documents

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