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
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.
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.
Calcineurin inhibitors for systemic use (ciclosporin; tacrolimus) and mammalian target of rapamycin (mTOR) inhibitors for systemic use (everolimus; sirolimus; temsirolimus)
PRAC signal recommendation
|
07/04/2022
Risk for drug interaction with cannabidiol leading to calcineurin inhibitors and mTOR inhibitors serum levels increased and toxicity. Further information and the changes to the product information in all EU languages are available on the EMA website.
Etifoxine
Referral
|
01/04/2022
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.
