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
Tadalafil
PSUR-outcome
|
05/10/2023
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.
Acetazolamide
PRAC signal recommendation
|
26/09/2023
Risk for Choroidal effusion and choroidal detachment. Further information and the changes to the product information in all EU languages are available on the EMA website.
Lamotrigine
PSUR-outcome
|
13/09/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Flurbiprofen
PSUR-outcome
|
06/09/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Apomorphine
PSUR-outcome
|
01/09/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Morphine, Morphine/Cyclizine
PSUR-outcome
|
09/08/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Hormone Replacement Therapy
Additional template
|
04/08/2023
update PIL Juli 2023
Ropivacaine
PSUR-outcome
|
26/07/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Midazolam (oromucosal solution, treatment of prolonged, acute, convulsive seizures)
PSUR-outcome
|
21/07/2023
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.
Polystyrene sulfonate
PSUR-outcome
|
21/07/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
