PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV (pharmacovigilance) 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
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.
Mifepristone/Misoprostol
PSUR-outcome
|
10/04/2024
Further information and amendments to the product information can be found on the EMA website.
Oxycodone hydrochloride/Paracetamol
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Rizatriptan
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Paracetamol/Pseudoephedrin
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Ibuprofen/Pseudoephedrine
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Tramadol
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.