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
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.
Nitric oxide
PRAC signal recommendation
|
09/01/2025
Risk for pulmonary oedema in patients with veno-occlusive disease. Further information and amendments to the product information can be found on the EMA website.
Azathioprine
PRAC signal recommendation
|
08/01/2025
Risk for non-cirrhotic portal hypertension / portosinusoidal vascular disease. Further information and amendments to the product information can be found on the EMA website.
Bilastine
PSUR-outcome
|
08/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
