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
Olmesartan
PRAC signal recommendation
|
11/01/2022
Risk for Autoimmune hepatitis. Further information and the changes to the product information in all EU languages are available on the EMA website.
Metamizole
PSUR-outcome
|
03/01/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexmedetomidine
PSUR-outcome
|
21/12/2021
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.
Bimatoprost
PSUR-outcome
|
21/12/2021
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 (transmucosal)
PSUFU
|
17/12/2021
Further information is available on the HMA-Website.
Dexamethasone
PSUR-outcome
|
10/12/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Valproate
PSUR-outcome
|
03/12/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Perindopril update
PSUR-outcome
|
03/12/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Irinotecan
PSUR-outcome
|
30/11/2021
Further information is available on the HMA-Website.
Lanthanum
PSUR-outcome
|
30/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
