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
Clomipramine New
PSUR-outcome
|
09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clozapine New
PSUR-outcome
|
09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Varicella vaccine (live) New
PSUR-outcome
|
09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Selegiline New
PSUR-outcome
|
09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rocuronium New
PSUR-outcome
|
09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rifampicin New
PSUR-outcome
|
08/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Prazepam New
PSUR-outcome
|
08/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Metoprolol New
PSUR-outcome
|
07/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levonorgestrel intra-uterine devices
PSUFU
|
19/12/2025
Further information is available on the HMA-Website.
Estradiol (except cream/balm/emulsion for application in female genital area)
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.
