What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Safety warnings
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Medical devices
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14/04/2025
The Federal Office for Safety in Health Care (BASG) has been informed that the manufacturer SEBBIN, which went bankrupt in March 2025, has no legal successor who continues to fulfil the manufacturer obligations arising from the Regulation (EU) 2017/745 on medical devices („MDR“), as amended.
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.
Measles /mumps /rubella vaccines (live, attenuated) New
PSUR-outcome
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02/04/2025
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.
Iobitridol New
PSUR-outcome
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18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone hydrochloride/Paracetamol New
PSUR-outcome
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18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bismuth subcitrate potassium / Metronidazole / Tetracycline New
PSUR-outcome
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18/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Aciclovir New
PSUR-outcome
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17/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phenylpropanolamine New
PSUR-outcome
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07/03/2025
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.