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
Search narrowed by
Caffeine / Codeine / Paracetamol / Propyphenazone, Acetylsalicylic acid / Caffeine / Codeine / Paracetamol
PSUR-outcome
|
10/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levomethadone
PSUR-outcome
|
10/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefixime
PSUR-outcome
|
09/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tamoxifen
PSUR-outcome
|
06/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Piritramide
PSUR-outcome
|
03/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Simvastatin
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.
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)
PSUR-outcome
|
02/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
