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
Epinephrine New
PSUR-outcome
|
12/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
ACE-inhibitors New
Additional template
|
12/05/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 24-25 March 2026.
Cetalkonium / Choline salicylate New
PSUR-outcome
|
12/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Buclizine / Codeine / Paracetamol, Caffeine / Codeine / Paracetamol New
PSUR-outcome
|
12/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Piretanide / Ramipril, Piretanide New
PSUR-outcome
|
11/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pethidine New
PSUR-outcome
|
11/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Digoxin
Additional template
|
04/05/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 24-25 March 2026.
Levamisole
Referral
|
29/04/2026
Further information can be found on the EMA website.
Hydroxycarbamide
Additional template
|
21/04/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 27 - 28 January 2026.
Albendazole New
PSUR-outcome
|
16/04/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
