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
Misoprostol (termination of pregnancy)
PSUR-outcome
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Chlormadinone acetat/Ethinylestradiol
Additional template
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Valproate
Additional template
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadobenic acid
PSUR-outcome
|
13/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadoteric acid (IV and intravascular fomulations)
PSUR-outcome
|
13/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ceftriaxone
PSUR-outcome
|
04/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Moxifloxacin systemic use
PSUR-outcome
|
04/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tacrolimus (topical formulations)
PSUR-outcome
|
01/03/2024
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.
Gadoteridol
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadoxetic acid disodium
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
