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
Hydrochlorothiazide
Additional template
|
09/11/2021
Further information is available in the CMDh press release (Report from the meeting held on 14-16 Sep) on the HMA-Website.
Hydrochlorothiazide/Spironolacton
PSUR-outcome
|
09/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amitriptyline
PSUR-outcome
|
08/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefoperazone
PSUR-outcome
|
08/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Allopurinol
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Betamethasone
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Carbamazepine
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
5-Fluorouracil
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Piperacilline
PRAC signal recommendation
|
29/10/2021
Risk for Haemophagocytic lymphohistiocytosis. Further information and the changes to the product information in all EU languages are available on the EMA website.
Warfarin
PRAC signal recommendation
|
29/10/2021
Risk for Anticoagulant-related nephropathy. Further information and the changes to the product information in all EU languages are available on the EMA website.
