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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Terbinafine New
PSUR-outcome
|
17/08/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pipamperone New
PSUR-outcome
|
13/08/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bisoprolol/Perindopril New
PSUR-outcome
|
10/08/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
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
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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.
