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
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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.
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.
Methylprednisolone (systemic formulations)
PSUR-outcome
|
02/09/2024
Further information and amendments to the product information can be found on the EMA website.
Hydroxycarbamide
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.
