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
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.
Oxytetracycline hydrochloride, hydrocortisone acetate, polymyxin B sulfate (ear/eye drops/suspension/ointment) New
PRAC signal recommendation
|
06/05/2025
Risk for hearing and vestibular disorders. Further information and amendments to the product information can be found on the EMA website.
Acenocoumarol New
PSUR-outcome
|
22/04/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levonorgestrel IUS
Additional template
|
22/04/2025
Further information can be found in the CMDh minutes from february 2025.
Busulfan New
PSUR-outcome
|
15/04/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Capecitabine
PSUR-outcome
|
15/04/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Tobramycin (nebuliser solution)
Additional template
|
07/04/2025
Further information can be found in the CMDh minutes from february 2025.
