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
Dexketoprofen / Tramadol
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bupropion
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Botulinumtoxin Typ A
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Valaciclovir
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Terbutaline
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Codeine/Ibuprofen
PRAC signal recommendation
|
25/10/2022
Risk for renal tubular acidosis and hypokalaemia. Further information and the changes to the product information in all EU languages are available on the EMA website.
Ciclosporin (systemic use)
PSUR-outcome
|
20/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ethinylestradiol
Additional template
|
18/10/2022
Further information is available in the CMDh press release (Report from the meeting held on 19-20 July 2022) on the HMA-Website.
Iopromide
PSUFU
|
13/10/2022
Further information is available on the HMA-Website.
Iomeprol
PSUFU
|
13/10/2022
Further information is available on the HMA-Website.
