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
Etifoxine
Referral
|
01/04/2022
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.
Lithium (excluding diagnostic medicinal products)
PSUR-outcome
|
31/03/2022
Further information is available in the CMDh press release (Report from the meeting held on 14-16 December 2021) on the HMA-Website.
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.
