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
Tamoxifen New
PSUR-outcome
|
06/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Piritramide New
PSUR-outcome
|
03/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Simvastatin (fixed dose combination products) New
Additional template
|
03/03/2026
Further information can be found in the CMDh minutes from december 2025.
Simvastatin New
PSUR-outcome
|
02/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gabapentin
PSUR-outcome
|
19/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pegylated liposomal doxorubicin New
PRAC signal recommendation
|
10/02/2026
Risk for Renal-limited thrombotic microangiopathy. Further information and amendments to the product information can be found on the EMA website.
Cefazolin; cefazolin, lidocaine hydrochloride New
PRAC signal recommendation
|
10/02/2026
Risk for Kounis syndrome. Further information and amendments to the product information can be found on the EMA website.
Tranexamic acid
PSUR-outcome
|
09/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Testosterone (topical use)
PSUR-outcome
|
03/02/2026
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.
Isotretinoin (oral formulations) New
PSUR-outcome
|
02/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
