FAQ - reportable qualified persons Which key personnel are companies required to report immediately? a. Companies which place medicinal products on the market (wholesalers)with an operating licence pu

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 8558/Edward has been diagnosed with type 2 diabetes (DM2). The donor/gametes have been permanently blocked.

Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank European Sperm Bank (DK257572) darüber informiert wurde, dass bei dem Samenspender 8558/Edward Typ 2 Diabetes (DM2) diagnostiziert wurde. Der Spender/die Spendergameten wurden permanent gesperrt.

Referenced at:

• European Sperm Bank - Donor - 8558/Edward

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that an offspring of the sperm donor 28203/INGO has been diagnosed with Joubert syndrome. The child shows a Dandy Walker malformation. The donor/gametes have been permanently blocked.

Update of the Core SmPC/PL.

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  Mustertext HRT | 323 KB
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  Link to the Core SmPC and to the Core PL at HMA Website
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  Link to the press release of CMDh at HMA Website

Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank European Sperm Bank (DK257572) darüber informiert wurde, dass bei einem Nachkommen des Samenspenders 28203/INGO das Joubert Syndrom diagnostiziert wurde. Das Kind zeigt eine Dandy Walker Malformation. Der Spender/die Spendergameten wurden permanent gesperrt.

Referenced at:

• European Sperm Bank - Donor - 28203/INGO

Veterinary Antimicrobial Consumption NEWS New Recording and reporting of spent medicinal products To comply with Regulation EU 2021/578, a second master data set for (veterinary) medicines antimicrobi

FAQ antibiotics flow New Legal questions 1. What is the legal basis for the obligation to collect consumption data on antimicrobial medicinal products? 2. Why are voluntary reporting requirements laid

Further information and amendments to the product information in all EU languages are available on the EMA website.

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  Mustertext Terazosin | 412 KB
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  Link to the EMA Website

Risk for intestinal angioedema. Further information and amendments to the product information can be found on the EMA website.

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  Mustertext AT II Blocker | 473 KB
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  Link to the EMA Website