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
Estradiol (except cream/balm/emulsion for application in female genital area) New
Additional template
|
19/12/2025
Correction of wording to be implemented following PSUSA on estradiol (except cream/balm/emulsion for application in female genital area) (PSUSA/00010440/202108). Further information can be found in the CMDh minutes from november 2025.
Amplodipine/Atorvastatin New
PSUR-outcome
|
15/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Trimethoprim (Mono) New
Additional template
|
04/12/2025
Further information regarding SmPC harmonisation are available in Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 14-15 October 2025.
Propylthiouracil New
PSUR-outcome
|
03/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Vancomycin New
PSUR-outcome
|
02/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Codeine New
PSUR-outcome
|
28/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Atenolol New
PSUR-outcome
|
28/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dorzolamide/Timolol New
Additional template
|
27/11/2025
Further information can be found in the CMDh minutes from october 2025.
Dorzolamide New
PSUR-outcome
|
27/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gabapentin New
PSUR-outcome
|
27/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
