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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Naphazoline New
Additional template
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15/05/2025
Further information can be found in the CMDh minutes from march 2025.
Naphazoline, naphazoline/zinc sulphate New
PSUR-outcome
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15/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Magnesium sulfate / sodium sulfate / potassium sulfate New
PSUR-outcome
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08/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Thiocolchicoside, paracetamol / thiocolchicoside New
PSUR-outcome
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07/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxytetracycline hydrochloride, hydrocortisone acetate, polymyxin B sulfate (ear/eye drops/suspension/ointment) New
PRAC signal recommendation
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06/05/2025
Risk for hearing and vestibular disorders. Further information and amendments to the product information can be found on the EMA website.
Acenocoumarol New
PSUR-outcome
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22/04/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Busulfan New
PSUR-outcome
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15/04/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tiagabine New
PSUR-outcome
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07/04/2025
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.
