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
Diclofenac (systemic formulations) New
PSUR-outcome
|
15/07/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Sumatriptan, Naproxen / Sumatriptan New
PSUR-outcome
|
09/07/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Enzalutamide; digoxin New
PRAC signal recommendation
|
08/07/2025
Laboratory test interference leading to falsely elevated digoxin plasma levels with enzalutamide. Further information and amendments to the product information can be found on the EMA website.
Etonogestrel New
PSUR-outcome
|
16/06/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Meropenem (fixed dose combination products) New
Additional template
|
12/06/2025
Further information can be found in the CMDh minutes from april 2025.
Meropenem New
PSUR-outcome
|
12/06/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Hydrocortisone (systemic formulations....) New
PSUR-outcome
|
06/06/2025
Hydrocortisone (systemic formulations except for products indicated in adrenal insufficiency in a modified release tablet formulation and except for centrally authorised products for adrenal insufficiency, paediatric use only). Further information…
Sertraline New
PRAC signal recommendation
|
06/06/2025
Risk for Multiple acyl-coenzyme A dehydrogenase deficiency (MADD). Further information and amendments to the product information can be found on the EMA website.
Sulfamethoxazole, trimethoprim (cotrimoxazole) New
PRAC signal recommendation
|
03/06/2025
Risk for Circulatory shock. Further information and amendments to the product information can be found on the EMA website.
Oxcarbazepine New
PSUR-outcome
|
02/06/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
