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
Methadone
PSUR-outcome
|
16/03/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Colistimethate sodium for intravenous use
PRAC signal recommendation
|
06/03/2023
Risk for Pseudo-Bartter syndrome. Further information and the changes to the product information in all EU languages are available on the EMA website.
Hydroxychloroquine
PSUFU
|
02/03/2023
Further information is available on the HMA-Website.
Zonisamide
PSUR-outcome
|
27/02/2023
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.
Lamivudine / Tenofovir disoproxil
PSUR-outcome
|
20/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ivermectin (systemic use)
PSUR-outcome
|
20/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefuroxime sodium (except for intracameral use)
PSUR-outcome
|
20/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefuroxime axetil
PSUR-outcome
|
20/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
HMG-CoA reductase inhibitors (statins) - correction
PRAC signal recommendation
|
10/02/2023
Risk for Myasthenia gravis. Further information and the changes to the product information in all EU languages are available on the EMA website.
Methotrexate
PSUFU
|
03/02/2023
Further information is available on the HMA-Website.
