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Clinical reports for Pandemic influenza vaccine H5N1 AstraZeneca - 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
Pandemic influenza vaccine H5N1 AstraZeneca
MAH
AstraZeneca AB
Active substance
PANDEMIC INFLUENZA VACCINE (H5N1) (LIVE ATTENUATED, NASAL)
ATC code
J07BB03
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/003963/0000
See the European Public Assessment Report (EPAR) on the EMA website 

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