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
Search narrowed by
Ibuprofen/Pseudoephedrine New
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Tramadol New
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Pseudoephedrine New
Referral
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Chlormadinone acetat/Ethinylestradiol New
Additional template
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Valproate New
Additional template
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadoteric acid (IV and intravascular fomulations) New
PSUR-outcome
|
13/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ceftriaxone New
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 New
PSUR-outcome
|
04/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadoteridol New
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 New
PSUR-outcome
|
01/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.