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
Levetiracetam New
PSUR-outcome
|
15/10/2025
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.
Diamorphine New
PSUR-outcome
|
03/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Timolol (systemic use)
PSUR-outcome
|
02/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
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.
Azathioprine New
PSUR-outcome
|
19/09/2025
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.
Hydromorphone New
PSUR-outcome
|
15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phosphocreatine New
PSUR-outcome
|
15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Acetylsalicylic acid / Bisoprolol New
PSUR-outcome
|
12/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Azithromycin-containing medicinal products for systemic use
Referral
|
10/09/2025
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.
Tapentadol New
PSUR-outcome
|
09/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
