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
salicylic acid (topical use) New
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.
Methotrexate
PSUR-outcome
|
05/09/2024
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.
Havrix and associated names
Referral
|
02/09/2024
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.
Methylprednisolone (systemic formulations) New
PSUR-outcome
|
02/09/2024
Further information and amendments to the product information can be found on the EMA website.
Hydroxycarbamide New
PSUR-outcome
|
30/08/2024
Further information and amendments to the product information can be found on the EMA website.
Posaconazole
PSUR-outcome
|
23/08/2024
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.
Atorvastatin
PSUR-outcome
|
19/08/2024
Further information and amendments to the product information can be found on the EMA website.
