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
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.
Teicoplanin
Additional template
|
28/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Chloroquine, hydroxychloroquine
PRAC signal recommendation
|
19/01/2021
Risk for psychiatric disorders. Further information and the changes to the product information in all EU languages are available on the EMA website.
Capecitabine
PRAC signal recommendation
|
19/01/2021
Risk for anaphylactic reaction. Further information and the changes 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.