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
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Leuprorelin
PSUR-outcome
|
14/06/2024
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.
Lithium
PSUR-outcome
|
14/06/2024
Further information and amendments to the product information can be found on the EMA website.
Vincristine
PSUR-outcome
|
12/06/2024
Further information and amendments to the product information can be found 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.
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.