PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV 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
Vancomycin-containing medicinal products (parenteral formulations for intravenous use) New
Additional template
|
19/11/2024
Further information is available in the CMDh press release (Report from the meeting held on 17-18 September 2024) on the HMA-Website.
Levonorgestrel/Ethinylestradiol, Ethinylestradiol (combination pack) New
PSUR-outcome
|
14/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Liothyronine New
PSUR-outcome
|
13/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Zoledronic acid New
PSUR-outcome
|
13/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fluoroquinolones (for systemic and inhalation use) New
PSUFU
|
08/11/2024
Further information is available on the hma-Website.
5_Fluorouracil (iv use) New
PSUR-outcome
|
08/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amantadine New
PSUR-outcome
|
30/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amitriptyline/Perphenazine
PSUR-outcome
|
29/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
valproic acid and derivates New
PSUR-outcome
|
29/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amitriptyline, Amitriptyline/Amitriptylinoxide, Amitriptylinoxide
PSUR-outcome
|
29/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
