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
Estradiol / Nomegestrol acetate New
PSUR-outcome
|
18/02/2025
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.
Oxaliplatin New
PSUR-outcome
|
06/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nebivolol New
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Promethazine New
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) New
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pemetrexed New
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) New
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Metformin New
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.
