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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Tranexamic acid
PSUR-outcome
|
09/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Testosterone (topical use)
PSUR-outcome
|
03/02/2026
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.
Isotretinoin (oral formulations)
PSUR-outcome
|
02/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cytarabine
PSUR-outcome
|
02/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Linezolid
PSUR-outcome
|
30/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nefopam
PSUR-outcome
|
29/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefditoren
PSUR-outcome
|
16/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Codeine/paracetamol
PSUR-outcome
|
15/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clomipramine
PSUR-outcome
|
09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clozapine
PSUR-outcome
|
09/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
