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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Ciclosporin (systemic use)
PSUR-outcome
|
20/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Erlotinib
PSUR-outcome
|
07/10/2022
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.
Donepezil
PSUR-outcome
|
06/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Chlormadinone acetate / Ethinylestradiol
PSUR-outcome
|
04/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Edotreotide
PSUR-outcome
|
22/09/2022
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.
Hydromorphone
PSUR-outcome
|
13/09/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tapentadol
PSUR-outcome
|
09/09/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexketoprofen
PSUR-outcome
|
16/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Soybean phospholipids (oral use)
PSUR-outcome
|
16/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Diclofenac systemisch
PSUR-outcome
|
11/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
