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
Clarithromycin
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tramadol
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Irinotecan
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Xylometazoline
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website
Iomeprol
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Iodixanol
PSUR-outcome
|
23/03/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Prednisolone, Prednisone
PRAC signal recommendation
|
11/03/2021
Risk for bradycardia. Further information and the changes to the product information in all EU languages are available on the EMA website.
Mycophenolate mofetil, mycophenolic acid
PSUR-outcome
|
02/03/2021
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.
Somatropin
PSUR-outcome
|
02/03/2021
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.
Anastrozole
PRAC signal recommendation
|
15/02/2021
Risk for depressed mood disorders. Further information and the changes to the product information in all EU languages are available on the EMA website.