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
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.
Ifosfamide
Referral
|
25/06/2021
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.
Tacrolimus, Sertraline, Valproate, Methadone, Efavirenz- pharmacokinetic interaction with Metamizole
Additional template
|
21/06/2021
Further information is available in the CMDh press release (Report from the meeting held on 10-11 November 2020) on the HMA-Website
Ethinylestradiol
Additional template
|
21/06/2021
Further information is available in the CMDh press release (Report from the meeting held on 23-24 February 2021) on the HMA-Website
Tramadol; tramadol, dexketoprofen; tramadol, paracetamol
PRAC signal recommendation
|
09/06/2021
Risk for serotonin syndrome. Further information and the changes to the product information in all EU languages are available on the EMA website.
Clindamycin (for systemic use)
PRAC signal recommendation
|
09/06/2021
Risk for acute renal failure. Further information and the changes 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.
Sulfamethoxazol Trimethoprim
PRAC signal recommendation
|
08/06/2021
Risk for HLH. Further information and the changes to the product information in all EU languages are available on the EMA website.
Sulfamethoxazol/Trimethoprim
PRAC signal recommendation
|
08/06/2021
Risk for ARDS. Further information and the changes to the product information in all EU languages are available on the EMA website.
