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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Miconazole
PSUR-outcome
|
18/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexketoprofen
PSUR-outcome
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18/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Methylphenidat
PSUR-outcome
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18/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Benzydamine
PSUR-outcome
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30/07/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
measles / mumps / rubella / varicella vaccines (live)
PSUR-outcome
|
23/07/2025
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.
Diclofenac (systemic formulations)
PSUR-outcome
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15/07/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Sumatriptan, Naproxen / Sumatriptan
PSUR-outcome
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09/07/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Etonogestrel
PSUR-outcome
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16/06/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Meropenem
PSUR-outcome
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12/06/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Hydrocortisone (systemic formulations....)
PSUR-outcome
|
06/06/2025
Hydrocortisone (systemic formulations except for products indicated in adrenal insufficiency in a modified release tablet formulation and except for centrally authorised products for adrenal insufficiency, paediatric use only). Further information…
