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
Paroxetine
PRAC signal recommendation
|
07/04/2020
Microscopic colitis. Further information and amendments to the product information in all EU languages can be found on the EMA website.
Pholcodine
PSUR-outcome
|
06/04/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Iobitridol
PSUR-outcome
|
06/04/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Estradiol-containing (0.01% w/w) medicinal products for topical use
Referral
|
24/03/2020
Further information and amendments to the product information can be found on the EMA website.
Methadone
PSUR-outcome
|
24/03/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Levomethadone
PSUR-outcome
|
13/03/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Sulfametrole / Trimethoprim, Sulfadiazine / Trimethoprim, Sulfamethoxazole / Trimethoprim (Co-trimoxazole)
PSUR-outcome
|
11/03/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Tolperisone
PSUR-outcome
|
11/03/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Moxifloxacin (systemic use)
PSUR-outcome
|
11/03/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Levonorgestrel
PSUR-outcome
|
10/03/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
