Clinical reports for Zurampic - Initial marketing authorisation

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The protocol and protocol amendments, sample case report form and documentation of statistical methods are incorporated in the documents under 'Clinical Study Report'.

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Clinical overview

The clinical overview provides a critical analysis of the clinical data in the eCTD.

Clinical summary

The clinical summary provides a detailed factual summary of the clinical information in the eCTD.

Clinical study reports

A clinical study report (CSR) on a clinical trial is a detailed document about the methods and results of a trial.

Anonymisation report

The anonymisation report describes the anonymisation process followed by the Applicant.

Product name
Grunenthal GmbH
Active substance
ATC code
Number of Documents
Procedure type
Initial marketing authorisation
Publication year
Product Status
Article 58
EMA procedure number
See the European Public Assessment Report (EPAR) on the EMA website