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
pneumococcal polysaccharide vaccine New
PSUR-outcome
|
11/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Caffeine / Codeine / Paracetamol / Propyphenazone, Acetylsalicylic acid / Caffeine / Codeine / Paracetamol New
PSUR-outcome
|
10/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levomethadone New
PSUR-outcome
|
10/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefixime New
PSUR-outcome
|
09/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
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.
