Clinical reports for Zavicefta - 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
Zavicefta
MAH
Pfizer Ireland Pharmaceuticals
Active substance
CEFTAZIDIME / AVIBACTAM
ATC code
J01DD52
Number of Documents
0
Procedure type
Initial marketing authorisation
Publication year
2017
Product Status
Authorised
Type
Article 58
No
EMA procedure number
EMEA/H/C/004027/0000
See the European Public Assessment Report (EPAR) on the EMA website