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
Hydroxycarbamide
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
PSUR-outcome
|
19/08/2024
Further information and amendments to the product information can be found on the EMA website.
Bumetanide
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
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)
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Clevidipine
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Nimodipine
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Ceftazidime
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Buprenorphine/Naloxone
PSUR-outcome
|
06/08/2024
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.
