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
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.
Buprenorphine (all formulations except implants)
PSUR-outcome
|
31/07/2024
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.
Teriflunomide
PSUR-outcome
|
31/07/2024
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.
Leflunomide
PSUR-outcome
|
29/07/2024
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.
