Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medicines
Safety Notices
My HPRA:
Login
Register
About Us
Medicines
COVID-19 vaccines and treatments
Our Role
Medicines Information
Safety Information
Safety Notices
Quality Information
Regulatory Information
News & Events
Special Topics
Emergency Medicines
Emergency Contact Details
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Updated recommendations to minimmise the risk of the rare brain infection PML with Tysabri. New advice may help early detection of PML and improve patients' outcomes
Notice type:
3rd Party Publications
Date:
12/02/2016
Problem Or Issue:
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of the risk of progressive multifocal leukoencephalopathy (PML) with multiple sclerosis medicine Tysabri (natalizumab) and has recommended new measures to minimise the risk. PML is a rare and very serious brain infection caused by John Cunningham (JC) virus.
The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA final opinion. HPRA will be contacting Healthcase Professionals in due course.
Background Information Or Related Documents:
PRAC recommendation for Tysabri can be seen
here
.
Further Information:
For full EMA statement please see
here
« Back
Date Printed: 25/04/2024