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
Oxacillin New
PRAC signal recommendation
|
29/09/2026
Risk for drug reaction with eosinophilia and systemic symptoms (DRESS). Further information and amendments to the product information can be found on the EMA website.
Lithium New
Additional template
|
29/09/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 21-22 July 2026.
Tropicamide New
Additional template
|
29/09/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 21-22 July 2026.
Phenylephrine / Tropicamide New
PSUR-outcome
|
28/09/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Choline Salicylate New
PSUR-outcome
|
02/09/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ramipril/Bisoprolol New
PSUR-outcome
|
02/09/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dimenhydrinate, Dimenhydrinate/Caffeine New
PSUR-outcome
|
02/09/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Methotrexate
PSUR-outcome
|
26/08/2026
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.
Telmisartan (fixed dose combination products)
Additional template
|
24/08/2026
Further information can be found in the CMDh minutes from July 2026.
Sulfonylureas
Additional template
|
21/08/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 23-25 June 2026.
