What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Estradiol (except cream/balm/emulsion for application in female genital area) New
Additional template
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19/12/2025
Correction of wording to be implemented following PSUSA on estradiol (except cream/balm/emulsion for application in female genital area) (PSUSA/00010440/202108). Further information can be found in the CMDh minutes from november 2025.
Safety warnings
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Blood & Tissue
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16/12/2025
The Federal Agency for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed autochthonous cases of Chikungunya have been reported in Bellaria-Igea Marina (province of Rimini) in Italy.
Amplodipine/Atorvastatin New
PSUR-outcome
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15/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
10/12/2025
Referenced at:
Propylthiouracil New
PSUR-outcome
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03/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Vancomycin New
PSUR-outcome
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02/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Codeine New
PSUR-outcome
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28/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Atenolol New
PSUR-outcome
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28/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dorzolamide/Timolol New
Additional template
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27/11/2025
Further information can be found in the CMDh minutes from october 2025.