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
Methylprednisolone (systemic formulations) New
PSUR-outcome
|
02/09/2024
Further information and amendments to the product information can be found on the EMA website.
Hydroxycarbamide New
PSUR-outcome
|
30/08/2024
Further information and amendments to the product information can be found on the EMA website.
Posaconazole
PSUR-outcome
|
23/08/2024
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.
Atorvastatin New
PSUR-outcome
|
19/08/2024
Further information and amendments to the product information can be found on the EMA website.
Bumetanide New
PRAC signal recommendation
|
14/08/2024
Risko for toxic epidermal necrolysis and Stevens-Johnson syndrome. Further information and amendments to the product information can be found on the EMA website.
Acetazolamide New
PRAC signal recommendation
|
14/08/2024
Pulmonary oedemas. Further information and amendments to the product information can be found on the EMA website.
Minoxidil (topical formulation) New
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Clevidipine New
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Nimodipine New
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Ceftazidime New
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
