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
Ibuprofen/Pseudoephedrine
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Tramadol
PSUR-outcome
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Pseudoephedrine
Referral
|
08/04/2024
Further information and amendments to the product information can be found on the EMA website.
Nimesulide (topical formulations)
PSUR-outcome
|
04/04/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Mifepristone
PSUR-outcome
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Misoprostol (termination of pregnancy)
PSUR-outcome
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Chlormadinone acetat/Ethinylestradiol
Additional template
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Valproate
Additional template
|
22/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadobenic acid
PSUR-outcome
|
13/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gadoteric acid (IV and intravascular fomulations)
PSUR-outcome
|
13/03/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
