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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Cladribine (apart from products with multiple sclerosis indication)
PSUR-outcome
|
16/01/2025
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.
Bilastine
PSUR-outcome
|
08/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rivastigmine
PSUR-outcome
|
07/01/2025
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.
Chlorphenamine maleate / Paracetamol
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Lanthanum
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone
PSUR-outcome
|
07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Sugammadex
PSUR-outcome
|
19/12/2024
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.
Terazosin
PSUR-outcome
|
27/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Mesalazine
PSUR-outcome
|
25/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Zofenopril
PSUR-outcome
|
25/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
