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
Prednisone New
PSUR-outcome
|
26/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Trimethoprim New
PSUR-outcome
|
26/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Sodium citrate / sodium lauryl sulfoacetate, sodium citrate / sodium lauryl sulfoacetate / sorbitol New
PSUR-outcome
|
26/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Caspofungin New
PSUR-outcome
|
25/11/2025
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.
Bosutinib New
PRAC signal recommendation
|
24/11/2025
Risk for cutaneous vasculitis. Further information and amendments to the product information can be found on the EMA website.
Bosentan New
PSUR-outcome
|
07/11/2025
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.
Botulinum toxin a (except for centrally authorised products) New
PSUR-outcome
|
06/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bupropion New
PSUR-outcome
|
05/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Niflumic acid New
PSUR-outcome
|
03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium New
PSUR-outcome
|
03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
