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
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Hydroxycarbamide New
Additional template
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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
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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 New
Additional template
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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 New
Additional template
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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) New
PSUR-outcome
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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 New
PSUR-outcome
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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.
Mycophenolate mofetil, Mycophenolic acid New
PSUR-outcome
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09/04/2026
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.
Metronidazole/Miconazole New
PSUR-outcome
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08/04/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ropinirole New
PSUR-outcome
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08/04/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Galantamine New
PRAC signal recommendation
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07/04/2026
Risk for Nightmares. Further information and amendments to the product information can be found on the EMA website.
