PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV (pharmacovigilance) 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
Mycophenolate mofetil, Mycophenolic acid New
PSUR-outcome
|
09/04/2026
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.
Metronidazole/Miconazole New
PSUR-outcome
|
08/04/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ropinirole New
PSUR-outcome
|
08/04/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Galantamine New
PRAC signal recommendation
|
07/04/2026
Risk for Nightmares. Further information and amendments to the product information can be found on the EMA website.
Bromfenac New
PSUR-outcome
|
31/03/2026
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.
Captopril
PSUR-outcome
|
26/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Etodolac New
PSUR-outcome
|
19/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nicardipine New
PSUR-outcome
|
19/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ioversol New
PSUR-outcome
|
18/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Methadone New
PSUR-outcome
|
12/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
