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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Azathioprine
PSUR-outcome
|
19/09/2025
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.
Hydromorphone
PSUR-outcome
|
15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phosphocreatine
PSUR-outcome
|
15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Acetylsalicylic acid / Bisoprolol
PSUR-outcome
|
12/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tapentadol
PSUR-outcome
|
09/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nicotine (Amendments of the product information for oral and oromucosal formulations)
PSUR-outcome
|
08/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Stiripentol
PSUR-outcome
|
27/08/2025
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.
Levosimendan
PSUR-outcome
|
25/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Domperidone
PSUR-outcome
|
25/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Isoniazid
PSUR-outcome
|
18/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
