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
Betamethasone
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Carbamazepine
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
5-Fluorouracil
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Piperacilline
PRAC signal recommendation
|
29/10/2021
Risk for Haemophagocytic lymphohistiocytosis. Further information and the changes to the product information in all EU languages are available on the EMA website.
Warfarin
PRAC signal recommendation
|
29/10/2021
Risk for Anticoagulant-related nephropathy. Further information and the changes to the product information in all EU languages are available on the EMA website.
Amiodaron
PSUR-outcome
|
29/10/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., fructus / Melissa officinalis L., folium / Mentha piperita
PSUR-outcome
|
22/10/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ethinylestradiol
Additional template
|
15/10/2021
Further information is available in the CMDh Minutes (Meeting held on 22. - 23. June 2021)
Edotreotide
PSUR-outcome
|
05/10/2021
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.
Methotrexate
PRAC signal recommendation
|
01/10/2021
Risk for Progressive multifocal leukoencephalopathy. Further information and amendments to the product information in all EU languages are available on the EMA website.
