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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Mercaptopurine New
PSUR-outcome
|
25/06/2024
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.
Naproxen New
PSUR-outcome
|
14/06/2024
Further information and amendments to the product information can be found on the EMA website.
Lithium New
PSUR-outcome
|
14/06/2024
Further information and amendments to the product information can be found on the EMA website.
Vincristine New
PSUR-outcome
|
12/06/2024
Further information and amendments to the product information can be found on the EMA website.
Naloxone/Oxycodone New
PSUR-outcome
|
11/06/2024
Further information and amendments to the product information can be found on the EMA website.
Trimetazidine New
PSUR-outcome
|
11/06/2024
Further information and amendments to the product information can be found on the EMA website.
Dexibuprofen New
PSUR-outcome
|
11/06/2024
Further information and amendments to the product information can be found on the EMA website.
Chlorhexidine New
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 New
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 New
PSUR-outcome
|
08/05/2024
Further information and amendments to the product information can be found on the EMA website.