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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Tamoxifen New
PSUR-outcome
|
06/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Piritramide New
PSUR-outcome
|
03/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Simvastatin (fixed dose combination products) New
Additional template
|
03/03/2026
Further information can be found in the CMDh minutes from december 2025.
Simvastatin New
PSUR-outcome
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02/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pegylated liposomal doxorubicin New
PRAC signal recommendation
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10/02/2026
Risk for Renal-limited thrombotic microangiopathy. Further information and amendments to the product information can be found on the EMA website.
Cefazolin; cefazolin, lidocaine hydrochloride New
PRAC signal recommendation
|
10/02/2026
Risk for Kounis syndrome. Further information and amendments to the product information can be found on the EMA website.
Isotretinoin (oral formulations) New
PSUR-outcome
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02/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cytarabine New
PSUR-outcome
|
02/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Linezolid New
PSUR-outcome
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30/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nefopam New
PSUR-outcome
|
29/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
