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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'.

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

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

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

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

Product name
Zurampic
MAH
Grunenthal GmbH
Active substance
Lesinurad
ATC code
M04AB05
Number of Documents
0
Procedure type
Initial marketing authorisation
Publication year
2016
Product Status
Authorised
Type
Article 58
No
EMA procedure number
EMEA/H/C/003932/0000
See the European Public Assessment Report (EPAR) on the EMA website