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
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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.
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.
Benazepril / Hydrochlorothiazide
PSUR-outcome
|
14/04/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tiagabine
PSUR-outcome
|
12/04/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nimesulide (systemic formulations)
PSUR-outcome
|
12/04/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Lithium (excluding diagnostic medicinal products)
PSUR-outcome
|
31/03/2022
Further information is available in the CMDh press release (Report from the meeting held on 14-16 December 2021) on the HMA-Website.
Imatinib
PSUR-outcome
|
25/03/2022
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.
