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
Macrogol 3350- combinations (oral use) New
PSUR-outcome
|
29/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Allopurinol New
PSUR-outcome
|
29/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Medroxyprogesterone acetate (MPA) New
PRAC signal recommendation
|
08/10/2024
Risk for Meningioma. Further information and amendments to the product information can be found on the EMA website.
Cefpodoxime
PSUR-outcome
|
27/09/2024
Further information and amendments to the product information can be found on the EMA website.
Codeine/Ibuprofen
PSUR-outcome
|
16/09/2024
Further information and amendments to the product information can be found on the EMA website.
Dydrogesterone/Estradiol
PSUR-outcome
|
13/09/2024
Further information and amendments to the product information can be found on the EMA website.
salicylic acid (topical use)
PSUR-outcome
|
13/09/2024
Further information and amendments to the product information can be found on the EMA website.
Atomoxetine
PSUR-outcome
|
05/09/2024
Further information and amendments to the product information can be found on the EMA website.
Glatiramer
PSUR-outcome
|
05/09/2024
Further information and amendments to the product information can be found on the EMA website.
Hydrochlorothiazide/Nebivolol
PSUR-outcome
|
05/09/2024
Further information and amendments to the product information can be found on the EMA website.