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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Oxacillin New
PRAC signal recommendation
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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
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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
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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
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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
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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
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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
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02/09/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Carbidopa/Levodopa New
PSUR-outcome
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20/08/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Terbinafine New
PSUR-outcome
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17/08/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pipamperone New
PSUR-outcome
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13/08/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
