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
Manidipine
PRAC signal recommendation
|
11/06/2024
Risk for Ascites. Further information and the changes to the product information in all EU languages are available on the EMA website.
Naloxone/Oxycodone
PSUR-outcome
|
11/06/2024
Further information and amendments to the product information can be found on the EMA website.
Trimetazidine
PSUR-outcome
|
11/06/2024
Further information and amendments to the product information can be found on the EMA website.
Dexibuprofen
PSUR-outcome
|
11/06/2024
Further information and amendments to the product information can be found on the EMA website.
Chlorhexidine
PRAC signal recommendation
|
13/05/2024
Risk fpr persistent corneal injury and significant visual impairment. Further information and the changes to the product information in all EU languages are available on the EMA website.
Ethambutol
PRAC signal recommendation
|
08/05/2024
Risiko for DRESS. Further information and the changes to the product information in all EU languages are available on the EMA website.
Paracetamol/Tramadol
PSUR-outcome
|
08/05/2024
Further information and amendments to the product information can be found on the EMA website.
Quetiapine
PSUR-outcome
|
08/05/2024
Further information and amendments to the product information can be found on the EMA website.
Mycophenolate mofetil, Mycophenolic acid
PSUR-outcome
|
10/04/2024
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.
Fentanyl (transmucosal)
PSUR-outcome
|
10/04/2024
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.
