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
Bisoprolol New
PSUR-outcome
|
10/08/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tocopherol New
PSUR-outcome
|
10/08/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levonorgestrel intrauterine device 13,5 mg New
PRAC signal recommendation
|
06/08/2026
Increased risk of ectopic pregnancy. Further information and amendments to the product information can be found on the EMA website.
Desogestrel, Etonogestrel New
PRAC signal recommendation
|
05/08/2026
Risk for Meningioma. Further information and amendments to the product information can be found on the EMA website.
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
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
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
PSUR-outcome
|
05/06/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
