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
Trimethoprim
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
PSUR-outcome
|
26/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Caspofungin
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
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
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)
PSUR-outcome
|
06/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bupropion
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
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
PSUR-outcome
|
03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Testosterone (all formulations apart from topical use)
PSUR-outcome
|
03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
