Serious Skin Reactions Reported with Ibuprofen Use in Europe
Serious Skin Reactions Reported with Ibuprofen Use in Europe
$131.00
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee advises ibuprofen manufacturers to add warnings on patient information leaflets concerning acute generalized exanthematous pustulosis associated with use of the drug. HBW provides details about the skin reaction being noted and the informational changes required.
Author: Informa Pharma Intelligence
Publisher: HBW Insight
- Description
In its latest set of recommendations, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PARC) reported “Acute generalized exanthematous pustulosis (AGEP) has been reported with use of ibuprofen-containing products. Now Marketing Authorization Holders (MAHs) of these products in the European Union will have to update product information to include new warnings. HBW provides details about AGEP, recommendations by PARC and the specific responsibility of the MAHs in question.
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
Do you have a subscription to Datamonitor Healthcare, Biomedtracker or Meddevicetracker? You may already have access to these reports, contact your account manager or email pharma@informabi.com for further help or assistance.
Sign up to the