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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Zonisamide
PSUR-outcome
|
27/02/2023
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.
Lamivudine / Tenofovir disoproxil
PSUR-outcome
|
20/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ivermectin (systemic use)
PSUR-outcome
|
20/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefuroxime sodium (except for intracameral use)
PSUR-outcome
|
20/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefuroxime axetil
PSUR-outcome
|
20/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Methoxyflurane
PSUR-outcome
|
02/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bleomycin
PSUR-outcome
|
02/02/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fentanyl (transdermal patches, solution for injection)
PSUR-outcome
|
31/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Omeprazole
PSUR-outcome
|
30/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Vinorelbine
PSUR-outcome
|
30/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
