PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV (pharmacovigilance) issues.
Due to the relaunch of the EMA website in December 2023, you will find the current links to the entries prior to December 01, 2023 at https://www.ema.europa.eu
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Diazoxide New
PRAC signal recommendation
|
30/09/2025
Risk for necrotising enterocolitis neonatal. Further information and amendments to the product information can be found on the EMA website.
Levofloxacin (intravenous and oral use) New
Additional template
|
22/07/2025
Further information can be found in the CMDh minutes from may 2025.
