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
Oxycodone
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Hydroxychloroquine
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Isotretinoin (oral formulations)
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Praziquantel
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Chloroquine
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ofloxacin (systemic use)
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Methotrexate (for non-oncology indication(s))
PSUFU
|
21/01/2022
Further information is available on the HMA-Website.
Metamizole
PSUR-outcome
|
20/01/2022
Further information is available in the CMDh press release (Report from the meeting held on 9-11 November 2021) on the HMA-Website.
Spironolacton
PSUR-outcome
|
20/01/2022
Further information is available in the CMDh press release (Report from the meeting held on 9-11 November 2021) on the HMA-Website.
Dobutamine
PSUR-outcome
|
18/01/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
