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
Mycophenolate mofetil, Mycophenolic acid New
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) New
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 New
PSUR-outcome
|
10/04/2024
Further information and amendments to the product information can be found on the EMA website.
Oxycodone hydrochloride/Paracetamol New
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Rizatriptan New
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Paracetamol/Pseudoephedrin New
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Ibuprofen/Pseudoephedrine New
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Tramadol New
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Pseudoephedrine New
Referral
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Nimesulide (topical formulations) New
PSUR-outcome
|
04/04/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
