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
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 New
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.
Nicotine (Amendments of the product information for oral and oromucosal formulations) New
PSUR-outcome
|
08/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clozapine New
PRAC signal recommendation
|
03/09/2025
New aspect of the known risk of neutropenia/agranulocytosis with potential impact on the risk minimisation measures. Further information and amendments to the product information can be found on the EMA website.
Varicella vaccine (live); measles, mumps, rubella and varicella vaccine (live) New
PRAC signal recommendation
|
02/09/2025
New aspect of the known risk of encephalitis. Further information and amendments to the product information can be found on the EMA website.
Finasteride or Dutasteride New
Referral
|
01/09/2025
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.
Stiripentol New
PSUR-outcome
|
27/08/2025
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.
