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
Fenoterol
PSUR-outcome
|
21/07/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Carbidopa_Levodopa
PSUR-outcome
|
18/07/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Famotidine
PSUR-outcome
|
29/06/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clenbuterol
PSUR-outcome
|
27/06/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levonorgestrel intra-uterine devices
PSUFU
|
13/06/2023
Further information is available on the HMA-Website.
Adenosine
PSUR-outcome
|
12/06/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Midazolam (all pharmaceutical forms and indications apart from oromucosal solution indicated for the treatment of prolonged, acute, convulsive seizures)
PSUR-outcome
|
12/06/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxybutynin
PSUR-outcome
|
06/06/2023
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.
Meloxicam
PSUR-outcome
|
12/05/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ketorolac (systemic formulations)
PSUR-outcome
|
09/05/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
