What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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CHMP Monthly News
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26/11/2024
Up-to-date information from the 11.11.-14.11.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Metamizole New
Referral
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26/11/2024
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.
Mesalazine New
PSUR-outcome
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25/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Safety warnings
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Blood & Tissue
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25/11/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Dahme-Spreewald in Germany.
25/11/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der ECDC (European Centre for Disease Prevention and Control) mitgeteilt, dass in Deutschland, zusätzlich zu den bereits bekannt gegebenen Regionen, in Dahme-Spreewald, bestätigte humane WNV-Infektionen verzeichnet wurden.
Referenced at:
Zofenopril New
PSUR-outcome
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25/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Safety warnings
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Blood & Tissue
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22/11/2024
The Federal Office for Safety in Health Care has been informed by the Greek authorities that in Greece, in addition to the regions already announced, a confirmed human WNV infection has been recorded in Zografos.
Amiodarone New
PSUR-outcome
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22/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Safety warnings
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Medical devices
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22/11/2024
The Federal Office for Safety in Health Care (BASG) warns against a potential Contamination of non-sterile ultrasound gel „AquaUltra Clear“ of the manufacturer Ultragel Medical Kft. According to the manufacturer the affected LOT has been narrowed down to LOT-Number 2024-4 to 2024-10.
Safety warnings
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Blood & Tissue
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22/11/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the French authorities that a confirmed autochthonous case of chikungunya has been recorded in La Réunion (overseas department; town: Etang Salé).