Labeling Changes In Store For Hydroxychloroquine In EU After COVID-19 Experience

The risk of psychiatric disorders with chloroquine and hydroxychloroquine-containing medicines received renewed attention in the EU after they were being used as potential treatments for COVID-19.

Hydroxychloroquine
Chloroquine, Hydroxychloroquine Are Not Effective In Treating COVID-19 • Source: Shutterstock

The product information of all chloroquine and hydroxychloroquine-containing medicines marketed in the EU will have to be updated to warn about the risk of psychiatric disorders and suicidal behavior.

Changes to the product labeling of these medicines were recommended by the EMA’s pharmacovigilance committee, the PRAC late last...

More from Europe

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

Swissmedic Appoints Trivigno As New Agency Head From 2026

 

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By 

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

More from Geography