PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV 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
Risperidone oral solution New
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 New
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 New
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 New
PSUR-outcome
|
08/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rivastigmine New
PSUR-outcome
|
07/01/2025
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.
Chlorphenamine maleate / Paracetamol New
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Lanthanum New
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone New
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Sugammadex New
PSUR-outcome
|
19/12/2024
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.
Hormone Replacement Therapy New
Additional template
|
29/11/2024
Update of the Core SmPC/PL.
