PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV 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
Alfentanil
PSUR-outcome
|
05/07/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Brinzolamide
PSUR-outcome
|
05/07/2022
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.
Estradiol (except cream/balm/emulsion for application in female genital area)
PSUR-outcome
|
14/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gabapentin
PSUFU
|
10/06/2022
Further information is available on the HMA-Website.
Nifuroxazide
PSUR-outcome
|
09/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Etonogestrel
PSUR-outcome
|
09/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxcarbazepine
PSUR-outcome
|
07/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexamfetamine
PSUR-outcome
|
07/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Modafinil
PSUR-outcome
|
07/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Desloratadine
PSUR-outcome
|
03/06/2022
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.