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
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Pancreatin New
PRAC signal recommendation
|
24/06/2026
Risk for infection due to viral transmission. Further information and amendments to the product information can be found on the EMA website.
Metronidazole / neomycin / nystatin New
PSUR-outcome
|
05/06/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Epinephrine New
PSUR-outcome
|
12/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cetalkonium / Choline salicylate New
PSUR-outcome
|
12/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Buclizine / Codeine / Paracetamol, Caffeine / Codeine / Paracetamol New
PSUR-outcome
|
12/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Piretanide / Ramipril, Piretanide New
PSUR-outcome
|
11/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pethidine New
PSUR-outcome
|
11/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
