PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV 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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Nitric oxide New
PRAC signal recommendation
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09/01/2025
Risk for pulmonary oedema in patients with veno-occlusive disease. Further information and amendments to the product information can be found on the EMA website.
Azathioprine New
PRAC signal recommendation
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08/01/2025
Risk for non-cirrhotic portal hypertension / portosinusoidal vascular disease. Further information and amendments to the product information can be found on the EMA website.
Bilastine New
PSUR-outcome
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08/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Chlorphenamine maleate / Paracetamol New
PSUR-outcome
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07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Lanthanum New
PSUR-outcome
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07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone New
PSUR-outcome
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07/01/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Hormone Replacement Therapy New
Additional template
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29/11/2024
Update of the Core SmPC/PL.