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
Clobetasol
PSUR-outcome
|
02/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pregabalin
PSUR-outcome
|
02/12/2020
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.
Lamotrigine
PRAC signal recommendation
|
01/12/2020
Risk for photosensitivity. Further information and the changes to the product information in all EU languages are available on the EMA website.
Ceftriaxone
PRAC signal recommendation
|
01/12/2020
Risk for encephalopathy. Further information and the changes to the product information in all EU languages are available on the EMA website.
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.