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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Iobitridol New
PSUR-outcome
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18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone hydrochloride/Paracetamol New
PSUR-outcome
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18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bismuth subcitrate potassium / Metronidazole / Tetracycline New
PSUR-outcome
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18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Aciclovir New
PSUR-outcome
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17/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phenylpropanolamine New
PSUR-outcome
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07/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Spironolactone New
PSUR-outcome
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06/03/2025
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.
Hormone Replacement Therapy New
Additional template
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29/11/2024
Update of the Core SmPC/PL.
