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
Ifosfamide
PSUFU
|
17/04/2023
Further information is available on the HMA-Website.
Sufentanil
PSUR-outcome
|
14/04/2023
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.
Ropinirole
PSUR-outcome
|
14/04/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Voriconazole; Flucloxacillin
PRAC signal recommendation
|
13/04/2023
Risk for Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels. Further information and the changes to the product information in all EU languages are available on the EMA website.
Propofol
PRAC signal recommendation
|
13/04/2023
Risk for Medication errors that could potentially lead to life-threatening/fatal cases. Further information and the changes to the product information in all EU languages are available on the EMA website.
Carbetocin
PSUR-outcome
|
13/04/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Diltiazem
PSUR-outcome
|
24/03/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Venlafaxine
PSUR-outcome
|
17/03/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amikacin
PSUR-outcome
|
17/03/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bemiparin
PSUR-outcome
|
17/03/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
