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
Etonogestrel
PSUR-outcome
|
09/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxcarbazepine
PSUR-outcome
|
07/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexamfetamine
PSUR-outcome
|
07/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Modafinil
PSUR-outcome
|
07/06/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Desloratadine
PSUR-outcome
|
03/06/2022
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.
Cabazitaxel
PSUR-outcome
|
03/06/2022
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.
Amlodipine/Rosuvastatin, Perindopril/Amlodipine/Rosuvastatin
PSUR-outcome
|
17/05/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amlodipine
Additional template
|
17/05/2022
Further information is available in the CMDh press release (Report from the meeting held on 22-23 March 2022) on the HMA-Website.
Leuprorelin (Depot formulations)
PSUR-outcome
|
16/05/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Sildenafil
Additional template
|
15/04/2022
Further information is available in the CMDh press release (Report from the meeting held on 25-27 January 2022) on the HMA-Website.
