Latest Haemophilia B Clinical Trial 2018 Publications
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.