PHV-wordings
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.
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.
