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
Bendamustin
PSUR-outcome
|
25/11/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levonorgestrel / Ethinylestradiol, Ethinylestradiol (combination pack)
PSUR-outcome
|
09/11/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Iopamidol
PSUR-outcome
|
09/11/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phenylephrine
PSUR-outcome
|
09/11/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Citalopram; desvenlafaxine; escitalopram; fluoxetine; fluvoxamine; milnacipran; paroxetine; sertraline; venlafaxine; vortioxetine
PRAC signal recommendation
|
03/11/2020
Risk for postpartum haemorrhage. Further information and the changes to the product information in all EU languages are available on the EMA website.
Interferon alfa-2a; peginterferon alfa-2a
PRAC signal recommendation
|
07/10/2020
Risk for Neuromyelitis optica spectrum disorder. Further information and the changes to the product information in all EU languages are available on the EMA website.
Fluoroquinolones
PRAC signal recommendation
|
07/10/2020
Risk for heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection. Further information and the changes to the product information in all EU languages are available on the EMA website.
iron (parenteral preparations, except for iron dextran)
PSUR-outcome
|
24/09/2020
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.
Pancuronium
PSUR-outcome
|
24/09/2020
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.
Lenograstim
PSUR-outcome
|
14/08/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
