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
Oxaliplatin
PSUR-outcome
|
06/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nebivolol
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Promethazine
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ambrosia Artemisiifolia (sublingual use)
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pemetrexed
PSUR-outcome
|
04/02/2025
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.
Fentanyl (transdermal patches, solution for injection)
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Metformin
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Esomeprazole
PSUR-outcome
|
16/01/2025
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.
Cladribine (apart from products with multiple sclerosis indication)
PSUR-outcome
|
16/01/2025
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.
Risperidone oral solution
PRAC signal recommendation
|
09/01/2025
Risk for medication errors associated with accidental overdoses in children and adolescents treated with risperidone 1 mg/mL oral solution. Further information and amendments to the product information can be found on the EMA website.
