PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV 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
Tacrolimus (topical formulations)
PSUR-outcome
|
01/03/2024
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Gadoteridol
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadoxetic acid disodium
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadobutrol
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gentamicin (systemic use)
PSUR-outcome
|
15/02/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fentanyl (transdermal patches; solution for injection)
PSUR-outcome
|
15/02/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amphotericin B, lipid formulations
PRAC signal recommendation
|
08/02/2024
Risk for Hyperkalaemia. Further information and the changes to the product information in all EU languages are available on the EMA website.
Cefotaxime
PRAC signal recommendation
|
08/02/2024
Risk for Drug reaction with eosinophilia and systemic symptoms (DRESS). Further information and the changes to the product information in all EU languages are available on the EMA website.
Pirfenidone
PRAC signal recommendation
|
08/02/2024
Risk for Drug reaction with eosinophilia and systemic symptoms (DRESS). Further information and the changes to the product information in all EU languages are available on the EMA website.
Aprotinin
Additional template
|
02/02/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
