PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV 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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Perindopril
PSUR-outcome
|
11/08/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tobramycin (systemic use)
PSUR-outcome
|
06/07/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Naftifine
PSUR-outcome
|
08/06/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phenytoin
PSUR-outcome
|
08/06/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
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.
