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
Piretanide / Ramipril, Piretanide
PSUR-outcome
|
11/05/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pethidine
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
PSUR-outcome
|
16/04/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ciprofloxacin intravenous and oral use; moxifloxacin intravenous and oral use
Additional template
|
14/04/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 9-11 December 2025.
Nirtate
Additional template
|
14/04/2026
Please regard the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 24-25 February 2026.
Human normal immunoglobulin (IgG)
PSUR-outcome
|
14/04/2026
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.
Hydrochlorothiazide / Telmisartan, Telmisartan
PSUR-outcome
|
13/04/2026
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.
