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
Tenofovirdisoproxil
PSUR-outcome
|
17/01/2020
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.
Lisdexamfetamine
PSUR-outcome
|
16/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Simvastatin
Additional template
|
16/01/2020
Further information is available in the CMDh press release (Report from the meeting held on 12-14 November 2019) on the HMA-Website.
Erythromycin
PSUR-outcome
|
15/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Ezetimibe/Simvastatin
PSUR-outcome
|
15/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Vardenafil
PSUR-outcome
|
10/01/2020
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.
Acetylsalicylic acid
PSUR-outcome
|
13/12/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Fluoroquinolone (systemic use) update
Additional template
|
09/12/2019
Further information is available in the CMDh press release (Report from the meeting held on 15-17 October 2018) on the HMA-Website.
Cabergoline
PSUR-outcome
|
05/12/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Ciprofloxacin (systemic use) update
PSUR-outcome
|
29/11/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
