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
Imatinib
PSUR-outcome
|
25/03/2022
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.
Paracetamol
Additional template
|
25/03/2022
Further information is available in the CMDh press release (Report from the meeting held on 25-27 January 2022) on the HMA-Website.
Pholcodine
Additional template
|
24/03/2022
Further information is available in the CMDh press release (Report from the meeting held on 25-27 January 2022) on the HMA-Website.
Lactulose
PSUR-outcome
|
24/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pholcodine
PSUR-outcome
|
22/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Loperamide, Loperamide/Simeticone
PSUR-outcome
|
22/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levonorgestrel (all indications except emergency contraception)
PSUR-outcome
|
22/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Remifentanil
PSUR-outcome
|
18/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Paracetamol (IV formulation)
PSUR-outcome
|
18/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tacrolimus (systemic formulations)
PSUR-outcome
|
25/02/2022
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.
