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
X-ray contrast agents New
PRAC signal recommendation
|
08/07/2026
Risk for fixed drug eruption. Further information and amendments to the product information can be found on the EMA website.
Valproate and related substances New
PRAC signal recommendation
|
08/07/2026
Risk for neurodevelopmental disorders with paternal exposure. Further information and amendments to the product information can be found on the EMA website.
Gemcitabine New
PRAC signal recommendation
|
08/07/2026
Risk for drug reaction with eosinophilia and systemic symptoms (DRESS). Further information and amendments to the product information can be found on the EMA website.
Acetylsalicylic acid New
Additional template
|
06/07/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 19-20 May 2026.
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.
ACE-inhibitors
Additional template
|
12/05/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 24-25 March 2026.
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.
