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
Human normal immunoglobulin (IgG)
PSUR-outcome
|
14/04/2026
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.
Hydrochlorothiazide / Telmisartan, Telmisartan
PSUR-outcome
|
13/04/2026
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.
Mycophenolate mofetil, Mycophenolic acid
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
PSUR-outcome
|
08/04/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ropinirole
PSUR-outcome
|
08/04/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Galantamine
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
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
PSUR-outcome
|
19/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nicardipine
PSUR-outcome
|
19/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
