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 www.ema.europa.eu
Gadobenic acid New
PSUR-outcome
|
13/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadoteric acid (IV and intravascular fomulations) New
PSUR-outcome
|
13/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ceftriaxone New
PSUR-outcome
|
04/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Moxifloxacin systemic use New
PSUR-outcome
|
04/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tacrolimus (topical formulations) New
PSUR-outcome
|
01/03/2024
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.
Gadoteridol New
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadoxetic acid disodium New
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadobutrol New
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gentamicin (systemic use) New
PSUR-outcome
|
15/02/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fentanyl (transdermal patches; solution for injection) New
PSUR-outcome
|
15/02/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.