PHV-wordings

Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV issues.

PSUR-outcome | 10/11/2023

Further information and amendments to the product information in all EU languages are available on the EMA website.

PSUR-outcome | 27/10/2023

Further information and amendments to the product information in all EU languages are available on the EMA website.

PSUR-outcome | 23/10/2023

Further information and amendments to the product information in all EU languages are available on the EMA website.

Further inquiry note