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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Carboplatin
PSUR-outcome
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01/12/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Mesalazine
PSUR-outcome
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01/12/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ketoprofen topical use only
PSUR-outcome
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01/12/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Riluzole
PSUR-outcome
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25/11/2022
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.
Dorzolamide
PSUR-outcome
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22/11/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexlansoprazole, Lansoprazole
PSUR-outcome
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10/11/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexketoprofen / Tramadol
PSUR-outcome
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28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bupropion
PSUR-outcome
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28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Botulinumtoxin Typ A
PSUR-outcome
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28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Valaciclovir
PSUR-outcome
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28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.