Latest Haemophilia B Clinical Trial 2018 Publications

in: Genetically Modified Organisms

Final Report

Report of final results , April 2021

Year: 2021

Reporting of the final results of deliberate release into the environment of Genetically Modified Organisms used in investigational medicinal products

Responses and clarifications on Consent Conditions

Year: 2019

Correspondence between the notifier and the Agency relating to clarifications on the Consent Conditions.

Board Minute Extract of 13 November 2018

Year: 2018

An extract from the minutes of the EPA Board Meeting of 13 November 2018 at which the notification from uniQure Biopharma BV seeking consent to carry out a clinical trial at St James's Hospital Dublin was discussed.

G0667-01 Inspector's Report

Year: 2018

All documentation submitted in respect of this notification was taken into consideration by the EPA inspector in her report to the Board of the Agency.

G0667-01 Consent Conditions

Year: 2018

G0667-01 Consent Conditions issued to uniQure Biopharma BV on 21 November 2018 for a clinical trial using a Genetically Modified Organism (GMO) at St James's Hospital Dublin

Requests for further information and replies

Year: 2018

Requests from the Agency to the notifier for additional information and the responses received.

G0667-01 GMO Register Entry

Year: 2018

The GMO Register Entry provides significant details of the clinical trial.