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
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.
measles / mumps / rubella / varicella vaccines (live)
PSUR-outcome
|
23/07/2025
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.
Levofloxacin (intravenous and oral use) New
Additional template
|
22/07/2025
Further information can be found in the CMDh minutes from may 2025.
