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
Hydrocortisone (systemic formulations....)
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.
Chlorocresol/chlorhexidine/hexamidine New
PSUR-outcome
|
30/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Anastrozole New
PSUR-outcome
|
30/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Naphazoline New
Additional template
|
15/05/2025
Further information can be found in the CMDh minutes from march 2025.
Naphazoline, naphazoline/zinc sulphate New
PSUR-outcome
|
15/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Magnesium sulfate / sodium sulfate / potassium sulfate New
PSUR-outcome
|
08/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Thiocolchicoside, paracetamol / thiocolchicoside New
PSUR-outcome
|
07/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
