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
Phenobarbital
PSUR-outcome
|
25/05/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Buprenorphine (other formulations except for implant)
PSUR-outcome
|
25/05/2021
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
Quetiapine
PSUR-outcome
|
25/05/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fluocinolone acetonid
PSUR-outcome
|
14/05/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ezetimibe/Rosuvastatin
PSUR-outcome
|
12/05/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fosphenytoin
PSUR-outcome
|
10/05/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cisatracurium
PSUR-outcome
|
10/05/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Mifepristone
PSUR-outcome
|
10/05/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Varilrix and associated names
Referral
|
10/05/2021
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.
Azathioprine
PRAC signal recommendation
|
10/05/2021
Risk for Erythema nodosum. Further information and the changes to the product information in all EU languages are available on the EMA website.
