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
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Iodixanol
PSUR-outcome
|
23/03/2021
Further information and amendments 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.
Tenofovir disoproxil
PSUR-outcome
|
29/01/2021
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.
Deoxycholic acid
PSUR-outcome
|
29/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Lisdexamfetamine
PSUR-outcome
|
29/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Zonisamide
PSUR-outcome
|
28/01/2021
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.
Flucloxacillin
PSUR-outcome
|
28/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ethosuximide
PSUR-outcome
|
19/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Metamizole
PSUR-outcome
|
19/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
