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
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.
Iodixanol
PSUFU
|
13/10/2022
Further information is available on the HMA-Website.
Erlotinib
PSUR-outcome
|
07/10/2022
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.
Donepezil
PSUR-outcome
|
06/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Chlormadinone acetate / Ethinylestradiol
PSUR-outcome
|
04/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pneumococcal polysaccharide vaccine (23 serotypes)
PRAC signal recommendation
|
27/09/2022
Risk for extensive swelling of vaccinated limb. Further information and the changes to the product information in all EU languages are available on the EMA website.
Edotreotide
PSUR-outcome
|
22/09/2022
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.
