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
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.
Methoxyflurane
PSUR-outcome
|
02/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bleomycin
PSUR-outcome
|
02/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fentanyl (transdermal patches, solution for injection)
PSUR-outcome
|
31/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Omeprazole
PSUR-outcome
|
30/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Vinorelbine
PSUR-outcome
|
30/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Triptorelin
PSUR-outcome
|
30/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
