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
Iobitridol New
PSUR-outcome
|
18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone hydrochloride/Paracetamol New
PSUR-outcome
|
18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bismuth subcitrate potassium / Metronidazole / Tetracycline New
PSUR-outcome
|
18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Aciclovir New
PSUR-outcome
|
17/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phenylpropanolamine New
PSUR-outcome
|
07/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Spironolactone
PSUR-outcome
|
06/03/2025
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.
Fluticasone furoate
PSUR-outcome
|
25/02/2025
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.
Tacrolimus (systemic formulations)
PSUR-outcome
|
24/02/2025
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.
Estradiol
Additional template
|
24/02/2025
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.
Estradiol / Nomegestrol acetate
PSUR-outcome
|
18/02/2025
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.
