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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Stiripentol New
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 New
PSUR-outcome
|
25/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Domperidone New
PSUR-outcome
|
25/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Isoniazid New
PSUR-outcome
|
18/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Miconazole New
PSUR-outcome
|
18/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexketoprofen New
PSUR-outcome
|
18/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Methylphenidat New
PSUR-outcome
|
18/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Benzydamine New
PSUR-outcome
|
30/07/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levofloxacin (intravenous and oral use) New
Additional template
|
22/07/2025
Further information can be found in the CMDh minutes from may 2025.
Diclofenac (systemic formulations) New
PSUR-outcome
|
15/07/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
