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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Vancomycine
PSUR-outcome
|
21/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ibuprofen, Ibuprofen-Lysin (not indicated in Ductus arteriosus), Ibuprofen/Coffein
PSUR-outcome
|
10/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Verapamil
PSUR-outcome
|
10/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Vancomycin
PSUR-outcome
|
10/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website
Clobetasol
PSUR-outcome
|
02/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pregabalin
PSUR-outcome
|
02/12/2020
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.
Bendamustin
PSUR-outcome
|
25/11/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levonorgestrel / Ethinylestradiol, Ethinylestradiol (combination pack)
PSUR-outcome
|
09/11/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Iopamidol
PSUR-outcome
|
09/11/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phenylephrine
PSUR-outcome
|
09/11/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
